Pharmacovigilance Archives - Techsol Life Sciences

Understanding the Importance of CMC (Chemistry, Manufacturing, and Controls) documents in the Pharmaceutical Product Lifecycle

Vinoth — Mon, 08 Apr 2024 08:28:11 +0000

Understanding the Importance of CMC (Chemistry, Manufacturing, and Controls) documents in the Pharmaceutical Product Lifecycle

In the pharmaceutical industry, Chemistry, Manufacturing, and Controls (CMC) documents play a pivotal role in ensuring the quality, safety, and efficacy of pharmaceutical products throughout their lifecycle. These documents provide a comprehensive overview of the manufacturing process, from raw material sourcing to final product distribution, and are essential for regulatory compliance, quality assurance, risk management, and product development.

Types of CMC Documents

Following are some of the key CMC documents prepared and submitted to regulatory bodies in the pharmaceutical industry. Each document plays a crucial role in demonstrating the quality, safety, and efficacy of pharmaceutical products and ensuring compliance with regulatory requirements.

Chemical and Pharmaceutical Quality Data (Module 3): This document provides detailed information about the quality of the drug substance and drug product, including chemical and physical properties, manufacturing process, specifications, and analytical methods.

Drug Master File (DMF): A DMF is a confidential document submitted to regulatory agencies that contains detailed information about the manufacturing process, facilities, and controls for an active pharmaceutical ingredient (API) or excipient. It is typically submitted by the API manufacturer and referenced by drug product manufacturers in their regulatory submissions.

Batch Records: Batch records document the manufacturing process for each batch of drug product, including raw material usage, processing steps, in-process controls, and final product testing results. These records are critical for demonstrating batch-to-batch consistency and ensuring compliance with Good Manufacturing Practice (GMP) regulations.

Analytical Procedures and Methods: These documents describe the analytical methods used to test the quality of the drug substance and drug product, including identification, purity, potency, and stability testing. They provide assurance that products meet specifications and regulatory requirements.

Stability Studies: Stability studies assess the long-term and accelerated stability of drug products under various storage conditions to ensure product quality and shelf-life. These studies provide data on product degradation and help establish expiration dating and storage recommendations.

Process Validation Documentation: Process validation documentation demonstrates that the manufacturing process is capable of consistently producing products that meet quality specifications. It includes protocols, reports, and data from process validation studies, such as process qualification, process performance qualification, and continued process verification.

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Container Closure System (CCS) Documentation: This documentation provides information about the packaging materials and closure systems used to protect the drug product from contamination and maintain its stability. It includes specifications, compatibility studies, and validation data for the container closure system.

Cleaning Validation Documentation: Cleaning validation documentation demonstrates that equipment used in the manufacturing process is effectively cleaned to prevent cross-contamination and ensure product safety. It includes cleaning procedures, sampling plans, and analytical results from cleaning validation studies.

Quality Risk Management (QRM) Documentation: QRM documentation assesses and manages risks associated with the manufacturing process to ensure product quality and patient safety. It includes risk assessments, risk mitigation strategies, and documentation of risk management decisions.

Regulatory Filings and Submissions: CMC documents are included in regulatory filings and submissions to regulatory agencies, such as Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs). These submissions provide comprehensive data to support product approval and licensure.

Importance of CMC Documents

CMC (Chemistry, Manufacturing, and Controls) documents are crucial in the pharmaceutical industry for several reasons:

Regulatory Compliance: CMC documents are required by regulatory agencies to ensure that pharmaceutical products meet quality, safety, and efficacy standards. These documents provide detailed information about the manufacturing process, including the raw materials used, manufacturing procedures, and quality control measures.

Quality Assurance: CMC documents play a vital role in ensuring the quality and consistency of pharmaceutical products. By documenting every aspect of the manufacturing process, from sourcing raw materials to packaging the final product, companies can identify and address any issues that may arise and maintain high-quality standards.

Risk Management: Comprehensive CMC documentation helps pharmaceutical companies identify and mitigate risks associated with the manufacturing process. By documenting manufacturing procedures and quality control measures, companies can identify potential risks and implement measures to prevent them, reducing the likelihood of product recalls or regulatory issues.

Product Development: CMC documents are essential during the product development process, providing critical information that informs decision-making and helps companies optimize manufacturing processes. By documenting each stage of product development, companies can track progress, identify areas for improvement, and ensure that products meet regulatory requirements.

Supply Chain Management: CMC documents provide transparency and traceability throughout the supply chain, from raw material suppliers to the final product distribution. By documenting the sourcing and handling of raw materials, as well as manufacturing and distribution processes, companies can ensure the integrity of their supply chain and minimize the risk of contamination or adulteration.

Common Challenges with CMC Documentation

While CMC documentation is crucial for regulatory compliance and ensuring product quality in the pharmaceutical industry, several challenges are associated with its creation and maintenance:

Complexity: CMC documentation is highly technical and requires expertise in various disciplines, including chemistry, manufacturing, and regulatory affairs. Ensuring that the documentation is accurate, comprehensive, and compliant with regulatory requirements can be challenging.

Regulatory Changes: Regulatory requirements for CMC documentation are constantly evolving, and keeping up with these changes can be challenging. Companies must stay informed about new regulations and guidelines and update their documentation accordingly.

Data Management: CMC documentation often involves managing large amounts of data related to manufacturing processes, raw materials, and quality control measures. Ensuring the accuracy, integrity, and accessibility of this data can be challenging, especially in complex manufacturing environments.

Cross-Functional Collaboration: Creating and maintaining CMC documentation requires collaboration among multiple departments, including research and development, manufacturing, quality assurance, and regulatory affairs. Ensuring effective communication and coordination among these departments can be challenging.

Globalization: Many pharmaceutical companies operate globally, which can introduce additional challenges related to harmonizing CMC documentation across different regions and complying with varying regulatory requirements.

Technological Challenges: Implementing and maintaining the technological infrastructure needed to support CMC documentation, such as electronic document management systems and data analytics tools, can be challenging and require significant investment.

Audits and Inspections: Pharmaceutical companies are subject to regular audits and inspections by regulatory agencies to ensure compliance with CMC documentation requirements. Preparing for and responding to these audits can be time-consuming and stressful.

Emerging Trends in Managing CMC Documentation

As regulatory requirements continue to evolve, pharmaceutical companies are constantly seeking new strategies to optimize their CMC regulatory affairs (RA) processes. From embracing digitalization to leveraging advanced technologies, here are some emerging trends in managing CMC documentation that can help pharma companies enhance their CMC RA strategies:

1. Digitalization and Electronic Documentation

Digitalization enables pharmaceutical companies to move away from paper-based systems, reducing the risk of errors and improving efficiency. Electronic document management systems (EDMS) provide a centralized platform for managing CMC documentation, allowing for easy access and collaboration among team members. By implementing EDMS, companies can ensure compliance with regulatory requirements, such as the FDA’s Electronic Common Technical Document (eCTD) format, which is increasingly being adopted globally.

2. Artificial Intelligence (AI) and Machine Learning

AI and machine learning technologies are revolutionizing CMC RA by automating manual processes, analyzing complex data sets, and predicting outcomes. These technologies can help companies identify trends, optimize manufacturing processes, and make informed decisions to improve regulatory compliance and product quality.

Example: AI algorithms can be used to analyze CMC data from multiple sources, such as manufacturing processes and regulatory submissions, to identify potential compliance issues and propose corrective actions.

3. Blockchain for Data Integrity and Traceability

Blockchain technology provides an immutable and transparent record of transactions, making it ideal for ensuring data integrity and traceability in CMC documentation. By utilizing blockchain, pharma companies can create a secure and auditable trail of documentation, from raw material sourcing to product distribution. This not only enhances regulatory compliance but also improves trust among stakeholders, including regulators and consumers.

4. Advanced Data Analytics and Visualization

Advanced data analytics and visualization tools enable pharma companies to gain valuable insights from CMC documentation, leading to informed decision-making and process improvements. By analyzing data from manufacturing processes, clinical trials, and regulatory submissions, companies can optimize their CMC RA strategies and enhance product quality.

Example: Advanced Data analytics can be used to generate actionable insights using the integrated data from MES, QMS and ERP systems to identify correlations between manufacturing parameters and product quality attributes, enabling companies to adjust processes for improved efficiency and compliance.

5. Integration of Regulatory Compliance Solutions

Integrating regulatory compliance solutions into CMC RA processes can help pharma companies streamline regulatory operations and ensure compliance with evolving regulatory requirements. These solutions provide centralized management of regulatory documents, automated compliance checks, and real-time updates on regulatory changes.

Example: Pharma sponsors and CMOs can adopt a regulatory lifecycle & compliance management platform to define suitable KPIs for product safety, quality, and risk parameters to establish proactive real-time oversight of their manufacturing and quality operations while generating different types of CMC documentation mandated by different global regulations.

In conclusion, by embracing emerging trends in managing CMC documentation, pharmaceutical companies can optimize their CMC RA strategies, enhance regulatory compliance, and improve product quality. From digitalization and AI to blockchain and advanced analytics, these trends offer innovative solutions to the challenges of CMC RA in the dynamic pharmaceutical landscape.

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MoCRA Made Easy: A Comprehensive Guide to Cosmetic Safety Compliance

Vinoth — Mon, 29 Jan 2024 15:39:33 +0000

MoCRA Made Easy: A Comprehensive Guide to Cosmetic Safety Compliance

On December 14, 2023, the U.S. Food and Drug Administration (FDA) issued updated instructions for facility registration, product listing, safety substantiation, and reporting adverse events associated with cosmetic products, further solidifying its enhanced oversight role mandated by the Modernization of Cosmetics Regulation Act (MoCRA) of 2022.

This new legislation empowers the Food and Drug Administration (FDA) with broader oversight, aiming to ensure the safety and quality of cosmetic products for consumers. Let’s delve deeper into the key provisions of MoCRA in its fullest detail:

Facility Registration

Prior to MoCRA, cosmetic facilities operated largely under self-regulation. Recognizing the need for transparency and accountability, MoCRA mandates the registration of all establishments engaged in the manufacturing, packaging, labeling, or holding of finished cosmetic products for U.S. distribution and renew their registration every two years.. This registration process creates a comprehensive database, enabling the FDA to track cosmetic production and distribution pathways.

Facility Registration and the FDA Establishment Identifier (FEI):

MoCRA utilizes the existing FDA Establishment Identifier (FEI) system for facility registration. This means the required facility registration number will be your assigned FEI. To streamline the process, obtaining an FEI number beforehand is recommended.

> Checking for Existing FEI:

Before acquiring a new FEI, check if your firm already possesses one through the FEI Search Portal. Simply enter your company information to see if a matching FEI exists.

> Obtaining a New FEI:

If your firm lacks an assigned FEI, navigate to the “How can I request an FEI?” section within the FEI Search Portal. This section guides you through the process of requesting a new FEI, ensuring you have the necessary information and documentation readily available.

Form FDA 5066: Registration of Cosmetic Product Facility

MoCRA Submission Options Now Available:

As of January 8, 2024, the FDA offers SPL Xforms, a new Structured Product Labeling (SPL) authoring tool for streamlined cosmetic product facility registration and listing. This tool simplifies data entry and ensures compliance with SPL formatting requirements.

Additionally, the FDA continues to accept electronic submissions through Cosmetics Direct and SPL-formatted submissions via the Electronic Submissions Gateway (ESG). These established options provide flexibility for businesses already familiar with their functionalities.

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For those preferring a paper approach, Forms FDA 5066 and 5067 are now available for download and submission. Completed forms can be mailed or emailed to the designated addresses.

Compliance Dates under MoCRA

While MoCRA introduced mandatory facility registration and product listing for cosmetic products, the FDA is currently implementing a gradual enforcement timeline to provide the industry time to adjust. Here’s a breakdown of the key dates:

Original Statutory Deadline: December 29, 2023

Delayed Enforcement Start Date: July 1, 2024 (six months after the original deadline)

This means that:

> Existing facilities and products: All facilities operating and products marketed before December 29, 2023, must comply with the registration and listing requirements by July 1, 2024.

> New facilities and products: Facilities that began operating after December 29, 2023, and products first marketed after that date have until July 1, 2024 to register and list.

This temporary enforcement delay provides valuable time for industry stakeholders to familiarize themselves with the new requirements and prepare for compliance. However, it’s crucial to remember that MoCRA remains in effect, and all cosmetic facilities and products will eventually need to be registered and listed with the FDA.

For further information and detailed guidance, you can refer to the FDA’s document: Guidance for Industry: Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing.

Suspension of Facility Registration under MoCRA

The FDA has the authority to temporarily suspend a cosmetic facility’s registration if it meets two critical conditions:

> Serious Safety Risk: The agency must determine that a cosmetic product manufactured or processed by the facility and distributed in the US has a reasonable probability of causing serious adverse health consequences or death to humans. This could involve documented cases of severe allergic reactions, chemical burns, or other serious health issues linked to the product.

> Widespread Failure: The FDA must also have a reasonable belief that other products manufactured or processed by the facility may be similarly affected. This means the safety concern is not likely an isolated incident with a single product, but rather indicates a systemic issue or failure within the facility’s manufacturing practices or quality control measures.

Product Listing

Complementing facility registration, MoCRA introduces mandatory product listing for all cosmetic products marketed in the US. Manufacturers and distributors must submit detailed information, including product name, ingredients, labeling, and manufacturer details, to the FDA . This centralized product repository enhances traceability and facilitates targeted safety interventions if necessary.

Form FDA 5067: Cosmetic Product Listing

MoCRA Exemptions for Small Businesses

While MoCRA tightens regulations for most cosmetics, small businesses may qualify for exemptions from certain requirements like quality control practices, facility registration, and product listing. Understanding these exceptions helps small businesses navigate MoCRA and focus on necessary compliance measures.

However, these exemptions do not apply to all small businesses. The following product categories remain subject to full MoCRA requirements, regardless of the manufacturer’s size:

> Eye Products: Cosmetics intended for regular contact with the eye’s mucus membranes (e.g., mascara, eyeliner).

> Injectable Products: Any cosmetic product designed for injection.

> Internal Use Products: Cosmetics intended for internal consumption (e.g., teeth whiteners with internal application).

> Long-Lasting Appearance Products: Cosmetics that alter appearance for more than 24 hours without requiring consumer removal (e.g., hair dyes, permanent tattoos).

Person Responsible

Understanding who the responsible person is for a particular cosmetic product is essential for various stakeholders in the industry. For manufacturers and distributors, it clarifies their legal obligations and responsibilities under MoCRA. For consumers, it provides a clear point of contact for reporting concerns or seeking information about the product’s safety.

As per MoCRA, the responsible person is a representative group from either of these parties:

> The manufacturer: This includes any entity that produces or significantly alters the cosmetic product before its distribution in the US.

> The packer: This refers to the entity that packages the finished cosmetic product for distribution.

> The distributor: This encompasses any entity that introduces the finished cosmetic product into US commerce, including importers, wholesalers, and retailers.

Importantly, the responsible person is designated as the entity whose name appears on the product label in accordance with specific sections of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). This designation clarifies who is ultimately accountable for ensuring the product’s safety, labeling accuracy, and compliance with MoCRA’s requirements.

Adverse Event Reporting (MedWatch)

One of MoCRA’s most significant provisions is the mandatory reporting of serious adverse events (SAEs) associated with cosmetic products through the FDA’s MedWatch system. Responsible persons from manufacturers and distributors are now obligated to report any serious side effects experienced by consumers within 15 business days using MedWatch Form 3500A. The recently updated form simplifies reporting, facilitating efficient communication and enabling the FDA to swiftly identify and address potential safety concerns.

Safety Substantiation

Manufacturers are responsible for ensuring the safety of their cosmetic products. This involves having adequate safety data to support their claims. The level of data required will vary depending on the product’s ingredients and intended use.

The FDA encourages utilizing the Cosmetics Ingredient Review (CIR) Program, which evaluates the safety of cosmetic ingredients. Unlike drugs and medical devices, cosmetics don’t require premarket approval from the FDA. However, the agency can take action against unsafe products after they enter the market.

Certain low-risk products, such as soaps and shampoos, may be eligible for exemptions from some MoCRA requirements.

Enhanced Labeling Requirements

MoCRA elevates the bar for cosmetic labeling, prioritizing transparency and informed consumer choices. Manufacturers must now ensure labels are accurate, comprehensive, and readily understandable. Key requirements include:

Clear ingredient disclosure: Complete ingredient lists, often presented in descending order of concentration, empower consumers to make informed choices based on personal preferences or potential sensitivities.

Prominent display of warnings and risks: Labels must clearly communicate any potential risks associated with product use, such as skin irritation or allergic reactions. This allows consumers to make informed decisions about product suitability for their individual needs.

Contact information for responsible persons: MoCRA mandates the inclusion of readily accessible contact information for the manufacturer or distributor on the label. This facilitates direct communication between consumers and responsible parties, fostering trust and transparency.

The implementation of MoCRA represents a substantial step forward in safeguarding consumer well-being in the cosmetics business segement.

By understanding these key provisions, cosmetic manufacturers and distributors can effectively navigate the evolving regulatory landscape and ensure compliance with MoCRA’s requirements. This, in turn, contributes to building trust with consumers and fostering a sustainable future for the cosmetic industry in the United States.

MoCRA represents a significant step forward in ensuring the safety and quality of cosmetic products in the US. While navigating the new requirements may seem daunting, understanding the key elements and staying informed will help you adapt and thrive in this evolving landscape. Remember, compliance isn’t just about avoiding penalties; it’s about building trust with consumers and ensuring the continued success of your cosmetic business.

Schedule a free consultation on how we can help your organization to meet FDA’s MoCRA requirements through our comprehensive list of cosmetics safety services.

Key References

Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products
FDA MoCRA webpage: https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022-mocra
FDA Cosmetic Facility Registration and Product Listing: https://www.fda.gov/cosmetics
FDA Adverse Event Reporting System (CAERS): https://www.fda.gov/food/cfsan-constituent-updates/fda-begins-posting-adverse-event-report-data-foods-and-cosmetics
Modernization of Cosmetics Regulation Act of 2022 – Key Terms and Provisions https://youtu.be/p4UsMzXKyck
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-compliance-policy-cosmetic-product-facility-registration-and-cosmetic-product

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Best Practices for Signal Management in Pharmacovigilance

Techsol Life Sciences — Fri, 03 Dec 2021 12:27:00 +0000

December 3, 2021
Posted by: Techsol Life Sciences
Category: Pharmacovigilance

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Pharmacovigilance involves the collection, detection, assessment, and monitoring of data on Adverse Drug Reactions (ADRs) which must be evaluated to derive vital safety information. Signal detection involves monitoring the adverse reaction data for patterns that suggest new safety information. Safety signals can be detected from an extensive range of sources, such as spontaneous reports, clinical studies, and scientific literature.

The EudraVigiliance database is an important source of information on suspected adverse reactions and signals. Commission Implementing Regulation (EU) No 520/2012 (article 18) requires EMA, national competent authorities (NCAs), and marketing authorization holders (MAHs) to continuously monitor the data available in EudraVigiliance. It also requires MAHs to inform EMA and national competent authorities of validated signals detected when monitoring the database. [3] The evaluation of safety signals is essential to ensure that regulatory authorities have the latest information on the holistic benefits and risks of a medicine.

What Is A Signal?

The definition of a signal as provided by the council for international organizations of medical sciences (CIOMS) Working Group 8 is: “Information that arises from one or multiple sources (including observations and experiments), which suggests a new potentially causal association, or a new aspect of a known association, between an intervention and an event or set of related events, either adverse or beneficial, that is judged to be of sufficient likelihood to justify verificatory action”. [1]

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In essence, a signal is a hypothesis of a risk associated with medicine along with supporting data. The evidence in a signal is an early indication and not definitive as it substantially changes as the data accumulates over time. The evaluation of safety signals should be a continuous process in pharmacovigilance as it is imperative for manufacturing authorization holders to have a well-defined process to capture, evaluate and take immediate action on potential PV risks as needed. A signal may be generated either by quantitative analysis through data mining algorithms (DMAs) and statistical analysis or by qualitative analysis of spontaneous reports.

A signal may provide supplementary or new information about adverse or beneficial effects of an intervention, or data about a known association of medicine with an adverse drug effect. For example: postulating a mechanism based on the range of severity of effect, suggesting a dose range, and indicating an at-risk group or sometimes lack of effect by a particular medicine.

What Is Signal Management in Pharmacovigilance?

The process of signal management in pharmacovigilance consists of a set of activities that aim to determine if there are new risks associated with an active substance or a medicinal product or whether known risks have changed based on a thorough analysis of individual case safety reports (ICSRs), aggregate data from active surveillance systems or scientific literature. The set of activities includes the following steps:

The sources for signal detection can come from:

Spontaneous reporting
Active monitoring systems
Interventional studies (clinical trials)
Non-interventional studies (Pharmacoepidemiologic studies)
Non-clinical studies (e.g. Animal toxicology studies)
Systematic reviews (i.e. Review of the published literature)

Signal Management Overview

A signal must be assessed to determine its validity by investigating the clinical relevance and by comparing it with the standard available information. The main areas to focus on an adverse event and trends are:

1. Case Data and Case Quality:
  - Is the signal associated with a trend related to frequency, seasonality, or geographical location?
  - What are the expectations based on product distribution or clinical data as compared to historical data?
  - Is the data of good quality or most of the cases assessed as unclassifiable because the information provided is insufficient or contradictory?
2. Patient Data:
  - Is the signal associated with a trend related to the patient’s age, sex, profession, lifestyle, medical conditions, or other relevant factors?
3. Product Data:
  - Is the signal associated with a trend related to the product’s use (or misuse), serial/batch, location of the manufacturer, labeling, distribution?
4. Event Data:
  - Is the signal associated with a trend related to severity, frequency, time of onset, duration, progression, the outcome of the event?

Once a signal is identified, it must be further evaluated and classified either as a new risk or a previously reported risk. It is conducive to document and store all identified, ongoing, or closed signals as the information will be readily available to the signal management team for easy assessment and decision making. Do not discard refuted signal data, maintaining this in a searchable document management system can be very helpful for responding to National Competent Authorities (NCAs) inquiries or in evaluating similar signals in the future.

Challenges in Signal Management

Throughout the signal management process, multiple challenges can be encountered such as:

Continuous increase in data volumes
Large numbers of potential safety signals
- Drug-event combinations identified through disproportionality analysis
Large number of false positives
Signal scores below the threshold limit
No new cases or changes recorded over time
Associated with labeled or other reported event(s)
Reducing false positives to minimize the workload for signal evaluators
Providing better safety information before clinical trials begin

Best Practices for Signal Management

The best practices mentioned below refer to general areas to specific steps in the signal management process.

Comprehensive access to data is essential to perform signal management activities

Access to all valid documents and data sources is essential to PV evaluators involved in signal management to ensure thorough assessment. [2] Some of the most relevant documents and data sources are clinical trial data, product application dossier, SmPC, patient leaflet, PSURs, RMPs, EPITT, decision-making documents (e.g. from scientific committees or regulatory procedures), scientific literature, data provided by a marketing authorization holder (MAH) and data sources outside spontaneous reports, such as registries and databases, etc.[2]

Disproportionality methods should be applied to databases of the right size and background.

The practice of disproportionality methods is not suitable in all situations as the application of disproportionality methods to a dataset with a limited set of drugs or events reported may not provide any added benefits compared to using qualitative methods. Hence, it may be more appropriate to apply qualitative methods (e.g. count of case reports) for small databases.

The method of disproportionality analysis is insignificant compared to the chosen threshold for detection

It is important that any signal threshold applied is appropriate to the size of the database, the products it contains, and the level of sensitivity. This applies when complex disproportionality methods or rule-based approaches (such as reviewing all fatal case reports) are employed. [2] It is imperative that the chosen approach can be shown to identify signals through a validation process (the statistical analyses should be robust against false associations due to random variability). This process should ensure that the approach can detect issues that have been identified in the past for the products under review.

Prioritization should be a continuous process

Signal prioritization should be a continuous process. A standardized approach should be in place with predefined criteria and validated constantly. Careful prioritization of signals and related variables need to be implemented as a continuous process for effective signal management. [2]

Future Trends in Signal Management

Automated signal management processes will likely be the future trend as it augments quality and efficiency while remaining compliant. The computerized algorithms used in automated processes are able to complete many of the arduous steps, such as signal evaluation and validation, involving activities at the case and AE level and significantly reduce time, resources and expenses for signal management.

Using AI such as neural networks enables neural signal detection for greater modeling power and flexibility than the non-AI-based methods, greatly improving detection accuracy. Another method called multimodal signal detection represents an advanced process that can be employed when searching through large volumes of data located in disparate data sets. In this process, signal statistics are aggregated across the available data sets in order to generate a more accurate composite signal score.

Sponsors need a reliable and centralized system to track signals, ensuring all safety actions are reconciled in a standard manner, independent of therapeutic category or geography. The risk associated with a siloed and inefficient PV infrastructure is enormous. Companies need to scrutinize their safety signal information systems to minimize patient safety risks and also to avoid audit findings.

How We Can Help

Techsol has deep expertise across all signal management activities, including implementation, detection, validation, and assessment by using a wide range of sources, such as spontaneous cases, safety data from clinical trials, and literature reports. We are also experienced in the EudraVigilance Data Analysis System (EVDAS) functionality and can ensure that sponsors and Marketing Authorization Holders (MAHs) thoroughly comply with their signal detection and management obligations. With our technology and expertise organizations can benefit from an end-to-end Signal Management solution according to industry best practices and recent regulations (CIOMS VIII, GVP Module IX). To know more, please reach out to us at info@techsollifesciences.com.

References:

1. CIOMS. (2010). https://cioms.ch/wp-content/uploads/2018/03/WG8-Signal-Detection.pdf (No. WG8-signal).
2. SCOPE Work Package 5 Signal Management. Best Practice Guide – PDF Free Download. (2016). https://docplayer.net/79618432-Scope-work-package-5-signal-management-best-practice-guide.html
3. EMA. (2021, September 16). Signal management. European Medicines Agency. https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/signal-management

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Aggregate Reporting – Significance, Classification and Challenges

Techsol Life Sciences — Thu, 02 Sep 2021 05:44:00 +0000

September 2, 2021
Posted by: Techsol Life Sciences
Category: Pharmacovigilance

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Aggregate reports are the cumulative reports in the database that emphasise on evaluation of safety profile and risk-benefit analysis of a drug. Aggregate reporting is the process of compilation and submission of aggregate reports to the regulatory agencies over the period of the product’s life cycle (during pre-marketing and post-marketing phase) to provide a comprehensive view of the drug’s safety profile.

Why Aggregate Reporting?

Aggregate reports are intended to provide an evaluation of the benefit-risk analysis balance for submission by pharmaceutical companies to the regulatory authorities at a defined point of time during the post-authorization phase. But why is aggregate reporting essential?

As greater number of individuals are exposed to the drugs compared to clinical trials, it is essential that real-world drug safety information is gathered in the post-marketing phase. During this stage, rare AE (Adverse Events) that haven’t been identified earlier might come to light. Medicinal products administered in real-world patients with underlying diseases tend to have various reactions. When submitted through Aggregate reports, such information will prove crucial for further studies on deciding the limitations of the product.

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Moreover, the post-marketing studies conducted to demonstrate drug effectiveness and risk stratification can lead to discovery of deviations in the Benefit-Risk balance of medicinal products. But it isn’t logical to conclude it and continue/ discontinue the medicine without further study. Therefore, uninterrupted surveillance of the benefit-risk profile of the product is necessary. Comprehensive and critical analysis of novel and evolving information on the risks and evidence of benefits must be identified and reported all of which is clearly reflected in aggregate reports.

Classification of Aggregate Reports

Aggregate reports are required during both pre-marketing and post-marketing stages of a product. These aggregate reports are required during both pre-marketing and post-marketing stages of a product. Each of these reports identifies and highlights a specific aspect of risk or benefit. The aggregate reports for respective stages are listed below.

Pre-marketing Aggregate Reports:

Clinical Study Reports (CSRs)
IND annual reports in the USA
Development Safety Update Report (DSUR)
Annual Safety Reports (ASRs) in Europe

Post-marketing Aggregate Reports:

Periodic Safety Update Report (PSUR)
Periodic Benefit-Risk Evaluation Report (PBRER)
Periodic Adverse Drug Experience Report (PADER)
NDA and ANDA Annual Reports

Challenges in Aggregate Reporting

Owing to the nature of the process, companies often face multiple challenges while compiling the aggregate reports and submitting them compliantly. Most commonly noticed, the documentation process is often quite daunting considering the extensive range of reports that must be included in the submission. While moving to electronic platforms has created some ease in sorting the reports, it still remains complex.

Similarly, scheduling and assigning the tasks among the workforce by identifying the right resource for individual process remains a long-standing challenge that must be addressed. Even after having allocated the right resources, aggregate reporting continues to remain labour-intensive manual process, and tracking it via spreadsheets might make it more disarrayed.

Any updates to the reports must be uniform. Therefore timely updates of information from multiple stakeholders such as the regulatory team, safety and clinical team, and marketing team are required. Pharma companies are required to track the status of each report from submission to approval. Considering the gamut of data involved, they must also identify and review the line-listings for accuracy.

The high volumes of data involved in the reporting process continue to increase with each passing day. And with it, the risks for errors leading to non-compliance findings is a major reason for concern for the pharma companies.

Amidst all of these challenges, another common concern is that of regional regulatory requirements. From time to time, the regulatory guidelines are revised in phases and they are not uniform across the globe pushing the need for multiple trackers for multiple products and countries.

Companies continue to realize that some of these challenges can be addressed by harmonization of guidelines which the global regulatory bodies continue to work on. Meanwhile, adapting to intelligent solutions that are cloud-enabled and can be sourced instantly irrespective of geographic limitations and varying timelines could alleviate a major set of issues. They allow for better coordination and instant data access. Improve search criteria and sorting ability cuts down on the time required for filing the data for submission.

Compier Aggregate Reports

Amidst the growing complexity involved in aggregate reporting, pharma companies will find that automating the regulatory reporting lifecycle management could offer improved quality in authoring and will help to complete the review in time-bound scenarios providing respite to the stakeholders. To help companies achieve the same, Techsol is offering Compier Aggregate Reports, a key module of our Compier platform focused on pharma operations oversight and compliance governance.

Key Product Features

Report Schedule Management
Predefined Templates for PADER, PSUR,
PBRER, DSUR, CTPR & others as per business requirement
Digital Authoring
Collaborative Review
Workflow driven activities
Regulatory tracking
Access Control
Version Control
Auto Update Rules
Sharing Aggregate Reports
Alerts & Notifications
Insights & Analytics

If you want to understand how integrating Compier Aggregate Reports module can help you achieve digitalization and automation in associated processes or have queries with any other aspects of PV, please feel free to contact us at info@techsollifesciences.com.

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Literature Screening – Process overview, challenges en-route and the scope for automation

Techsol Life Sciences — Mon, 30 Aug 2021 05:03:00 +0000

August 30, 2021
Posted by: Techsol Life Sciences
Category: Pharmacovigilance

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Medical and scientific literature is a valuable source of safety information that helps in monitoring benefit-risk profiles and emerging safety issues of medicinal products. Literature screening is conducted to ascertain abstracts and articles that provide crucial information on serious and non-serious Individual Case Safety Reports (ICSR) reports and risk-benefit assessment of a drug.

The scientific literature is screened to identify individual adverse drug reactions or any special situations relevant to the therapeutic area. The literature is targeted to identify records such as ICSRs of adverse reactions, and aggregate reports-PSURs, PBRER and DSUR. The literature is also a source for the eventual follow-up and identification of a safety signal which is a new adverse event that has not occurred or seen before for a particular drug.

Marketing authorization holders (MAHs) are required to monitor and maintain awareness of possible suspected Adverse Drug Reactions (ADRs). The other important safety information to be monitored by MAHs are the class effects, off-label use, misuse and potential drug interactions at least once every week through a systemic literature review of widely used reference databases such as Medline, Embase etc. Reports of suspected adverse reactions from medical literature, including relevant published abstracts from meetings and draft manuscripts are anticipated to be reviewed and assessed from time to time.

Marketing authorization applicants are expected to conduct literature search before obtaining the marketing authorization. As the application is sent for approval, literature searches should begin to ensure the identification of any safety signals or emerging safety issues that could impact the benefit-risk ratio of the medicinal product.

Literature screening – An integral part of safety assessments

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The medical literature has been designated in line with the provisions set out in GVP Module VI that clarifies that regulators expect consistent screening to be an integral part of day-to-day drug safety operations and is based on the use of literature databases such as Embase.

The purpose of the screening and assessment process is to identify valid ICSRs related to

Suspected adverse reactions originating from spontaneous reports in humans
Special situations such as the use of a medicinal product during pregnancy or lactation or in the elderly population, off-label use, abuse, overdose, medication errors, and occupational exposure with suspected adverse reactions.
Lack of therapeutic efficacy: suspected adverse reactions related to quality defects in medicinal products
To understand spread of an infectious agent through a medicinal product.

Outline of steps involved in the Screening Process

An important aspect of pharmacovigilance, literature screening is more than just a drug safety regulatory requirement. It provides insights into safety issues like drug interactions to identify patient safety risks and preparation of critical reports that may have to be sent to regulatory bodies. This is incredibly time-consuming and labour-intensive work, with the risk of inefficiencies such as duplications. It requires judicious processing of records as it puts market authorization holders (MAH) at risk of non-compliance and regulatory fines. As part of the screening process, MAHs are expected to:

Identify and understand which publication reference databases are most relevant to each medicinal product (E.g. PubMed, Embase etc.).
Systematically monitor these databases for publications worldwide not frequently but at least once a week.
Intrinsically monitor all the “active substances” for which the organisations hold Marketing Authorisations.
Monitor articles published locally in each territory where the product is marketed
An initial review of the records should be performed based on title, keywords, citations and the available abstract.
Records, which could qualify for ICSR reporting, are moved to an inclusion group and which do not qualify for ICSR reporting, are archived in an exclusion group with the exclusion criteria recorded.
These records are further screened for any duplications as several reference databases are used to ensure wider journal coverage.
The results obtained are routed to the appropriate departments within the company to comprehend and comply with the time deadlines that apply to Individual Case Safety Reports Literature Screening.
Analyse and elaborate about any “new and significant safety findings” in the medicinal product’s PSUR (Periodic safety update report).
Immediately notify regulators of new safety information obtained from screening.

Challenges associated with Literature Screening

Growing regulatory scrutiny from regulatory bodies resulting in increased compliance requirements is placing additional pressure on sponsors. Additionally, the screening process itself is complex leading to multiple challenges which the marketing authorization applicants (MAAs) must navigate carefully.

Growing volumes of literature – As the research surrounding new indications and safety signals, the volume of literature continues to grow. As a result, the screening process becomes challenging for the MAAs.
Unexpected spikes in the number of references and weekly variations – Due to constant publications of articles in relation to clinical trials in conference proceedings and journals.
Duplicate references – Search strategies for diverse drugs and data migration are highly likely to produce duplicate references.
Regular maintenance and management of search strategy – It is a tedious process to maintain and manage database search systems regularly.
Building an ideal search strategy – A consistent approach for creating a comprehensive search strategy has not yet been defined.
Search strategy amendments -record keeping – Identification and keeping a record of key words, terms and phrases is time-consuming.
Output formats vary widely making it hard to reuse data downstream.
Increases cost of Literature review – Dealing with duplicate references can add up to 30% the cost of literature review.

Role of automation in improving literature monitoring process

Automation in literature screening helps identify both new and important ICSRs of Adverse Reactions and periodic safety update reports (PSUR) of a relevant medicinal product. The use of Natural Language Processing (NLP) aids in understanding the relationship between sentences during literature screening and quickly identifies ADEs from an extensive range of sources such as Embase and PubMed.

Automation considerably assists in the reviewing process of scientific literature and effectively screens the article channel from a single browser interface. It radically decreases review time by automatically eliminating repeated information. Automation can help improvise literature monitoring process in the following ways:

Reduces administrative burden using automatic import of articles, which results in reduced manual input thus eliminating human error
Decreases duplication of articles
A clear day zero which ensures consistency, reduces risk and saves time
(International Standards Organization (ISO) Individual Case Safety Report (ICSR) standard) E2B R3 XML output for more efficient integration with downstream applications
Expedites identification/ submission of serious ICSRs to case processing by using AI / Machine Learning (ML)
Demonstrates, mechanizes and tracks quality control
Increases oversight of outsourcing partners and internal KPIs
Inspection readiness of end-to-end process, audit trail, instant reports thus minimizing the risk of inspection findings
All software used in PV is part of the quality management system –validation is necessary

Machine learning (ML) can improve the efficiency of literature monitoring by highlighting key drug safety concepts. It can also help reduce the workload by carrying out a bulk review where multiple references can be identified as non-relevant. ML model assists reviewers and helps them manage risk as a priority. It expedites the reporting process and augments quality.

As the regulatory landscape of pharmacovigilance keeps evolving, MAHs will require to adapt and overcome process challenges from time to time. Enabling effective PV requires a strong literature screening process. Biopharma organizations will require expert assistance and advanced solutions that can guide them with a compliant and efficient approach. Choose a solution that can diligently address the current and anticipated regulatory guidelines for literature screening.

Techsol’s Compier Literature Screening Solution Overview

Identifying adverse events from medical literature is one of the key and most complex tasks in pharmacovigilance (PV). The huge volume of data available makes it difficult to conduct searches precisely, and only five percent of references retrieved are relevant. Literature screening has an extra layer of complexity, added by the issue of duplication of articles. On the other hand, regulatory authorities demand high levels of quality management, which is required to operate and meet the demanding standards.

Literature screening is one of the highly focused areas of PV at Techsol. We help companies identify all kinds of elements needed to screen literature articles using NLP (natural language processing). Our advanced NLP technology helps understand relationships in sentences in literature from a screening point of view. With this technology, we can help companies reduce 60% of manual effort and provide increased compliance which will directly influence the cross-savings for the companies.

Our service is structured to deliver quality outcomes for your pharmacovigilance system and is acutely focused on the recurrent review and quality check of literature references. Leveraging our global Compier Literature screening service delivers costs benefits through our scale of operation, and allows you to focus on other areas of your core business.

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How the Trial Master File is Expected to Evolve in the Next Three Years

Techsol Life Sciences — Wed, 28 Jul 2021 12:40:00 +0000

July 28, 2021
Posted by: Techsol Life Sciences
Category: Pharmacovigilance

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The Trial Master File (TMF) is the centralized repository that contains all the essential documentation generated right from the start of a clinical trial until its closure to demonstrate that the trial was conducted as per the clinical study protocol in compliance to the requirements of ICH E6 Good Clinical Practice. Managing the TMF is a huge responsibility for sponsors and affiliated CROs because it should remain accurate, complete and always ready for audits and inspections.

The Current State of the Electronic Trial Master File (eTMF)

In the last five years, there has been a rapid transition amongst sponsors to move away from the traditional paper-based TMF to a more robust electronic Trial Master File (eTMF). Due to the increasing demand to unify clinical processes, sponsors put forward the idea of integrating their eTMF application with their clinical trial management system (CTMS) in an effort to go paperless. The key commercial drivers motivating sponsors to move to eTMF are improved inspection readiness, rapid study start-up, and remote oversight of the TMF.

This has resulted in gaining real-time access to the review, update and monitor the contents of the TMF with simplified file management, robust document workflows, accountable audit trails, and seamless information exchange amongst stakeholders. Oversight has been made easier with personalized dashboards allow comprehensive monitoring of a clinical trial.

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The immense transformation in technology over the past decade has accelerated the need to be faster, more prolific, and competent. With the assistance of eTMF technology sponsors and CROs can speed up timelines, reduce the risk of minor and major findings, and better align with regulatory compliance that has been updated for a digital world. Those who have already adopted eTMF applications in particular report upgraded audit and inspection readiness, improved central and remote monitoring, and gained a better understanding of performance metrics.

Here is our take on how eTMF platforms can evolve in the next few years.

1. Increased Adoption of Artificial Intelligence to Automate eTMF Workflows

In the next two to three years, the emerging technologies such as Artificial Intelligence (AI) and Machine Learning (ML) can further advance the eTMF by eliminating resource intensive cumbersome tasks to increasing stakeholder collaboration. It can transform the eTMF from being a traditional document repository to an intelligent platform for improved ICH-GCP compliance. With rising workload and complexity in clinical research eTMF system can propel document storage, security and access controls, audit trails, and system validation, and drive compliance throughout the study.

The increasing variability in the documents required by regulatory authorities has steered the need for automation and ML for processing clinical and regulatory documentation. As a move towards greater data standardization, modern-day cloud computing services offer a scalable means to store and process large libraries of documents. The industry’s steady adoption of Standard Reference Model version 3.2 aids in providing more consistent and reliable terminology that ML can identify as metadata. Coalescing the eTMF system with ML can improve TMF operations through more automated document transfer, classification and indexing. For example, with integrated ML it is possible to convert a physical document into structured data that can be automatically processed, and subsequently useful knowledge can be extracted.

1.1. How Machine Learning can enhance the eTMF

A Machine Learning (ML) application uses a neural network, a structure analogous to the network of neurons in the human brain to train a machine to learn from experience by processing examples to analyse without relying on traditional computer programs. With ML, there are a wide range of TMF related manual activities that can be automated based on pattern recognition. For example, the auto-identification and auto-classification of different types of source data, auto-translation of multi-lingual source documents, and auto-redaction of personally identifiable information (PII) are some of the significant benefits that can be realized with ML capability.

1.2 Reducing redundant tasks with predefined integrated workflows

eTMF systems can be configured with pre-defined workflows to trigger event-driven external document exchange as well as internal document management with automated eSignatures that facilitate contract execution, training sign-offs, and internal SOP management within the platform.

1.3 Extraction of Metadata embedded in unstructured text

Manual entry is the most common way firms get metadata into eTMF systems. Metadata consists of attributes that describe a document, such as the research data to which the document relates. System operators depend on metadata to trace documents in eTMF databases. By using optical character recognition (OCR), the neural network can be trained to recognize an extracted attribute such as the name of a study to an index that links the document containing it to the correct study. Thus, ML can minimise manual entry of filing TMF documents by automating classification and indexing. It could also stimulate metadata standardization by decreasing errors and maintaining uniformity. As a result, ML has the potential to fast-track TMF filing processes with fewer corrections and rework.

1.4 Minimizing interoperability challenges with ML

As clinical trials can be large and complex linking many sponsor departments, investigator sites and contract research organisation (CRO), the management of the TMF can become challenging. Automating the process of sharing data across multiple systems leads to minimal development timelines. Thus companies can progress their TMF operations with improved data integration and easy access to auditors. Sponsors have also reported a reasonable decline in labour, acceleration in uploading documents, quality enhancement and standardization.

2. The Rise of Automated Document Quality Control in the eTMF

In recent times, the frequency of compliance updates from regulatory authorities and International Standards Organizations (ISO) has increased. The European Medicines Agency (EMA) published new guidelines on content and essential documents management and archiving of the TMF. With the introduction of these composite guidelines, it is becoming increasingly difficult to remain compliant. Additionally, even the slightest changes in terminology, procedures and processes are bound to increase the compliance efforts.

Considering these impediments, we can predict that modern eTMF systems will have the capability of automated Quality Checks (QC). Automated QC eliminate if not reduce the manual QC findings and provide regular signals for low performing study sites. They will also be capable of organising content within a shorter time frame, and forecasting inspection outcomes to comply with various regulatory requirements.

3. Orchestrating eTMF Real-Time Collaboration between Clinical Research Sites, Sponsors and Regulators

Clearly, the modern eTMF (Electronic Trial Master File) system is no longer a mere manuscript repository. It serves as an active platform for accelerating clinical trials, reducing compliance risks and ensuring real-time collaboration between research sites, sponsors and regulators.

More than ever before, today research is significantly outsourced as the demand for integrated systems has increased to enable better collaboration between sponsors, investigator site and CRO. The systems that hold research content outside of the eTMF (e.g. within external email servers) are usually siloed leading to inconsistent and inaccurate descriptions amongst internal and external teams. As illustrated here, lack of common lexicon and communication between organizations often creates data management challenges when it comes to portraying the entire TMF.

The integration of the eTMF system with the research site and Electronic Investigator Site File (eISF) can ensure TMF completeness. This combination allows for real-time, quality controlled remote monitoring, and document exchange with sites considerably reducing document cycle time. It also moderates the amount of time CRAs spend on site. Compliance risks can be effectively managed by swiftly identifying missing and incomplete documents across the Sponsor, CRO and participating research sites eTMF systems.

Most recently, sponsors and clinical research sites have voiced the need for tools that envision the evolution of Key Performance Indicators (KPIs) throughout the clinical trial. KPIs represent Individual and Vendor Performance, TMF Timeliness, and QC Findings. Although many organizations have KPIs in place, users need TMF completeness metrics for better awareness of their level of inspection readiness.

Keeping up with the growing requirements, eTMF solution providers are introducing more advanced data visualization and reporting capabilities that can describe the entire TMF content. With integrated reporting, researchers will be able to draw connections between data to enable strategic decision-making. In the next three to five years, biopharma companies can expect spontaneous navigation and process mapping between systems that contribute to the TMF. This practice of integrated document management will ease the process of inspection with the complete single source of truth to auditors.

How We Can Help

Techsol’s eSource System Integration and Validation practice focuses on introducing latest technology innovation and best practices that can be scaled to requirements of your organization. With our clinical development and technology expertise, our team can lay down the technology roadmap to implement, validation and optimize your current trial master file management process. To know more, please reach out to us at info@techsollifesciences.com.

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Automation Opportunities in Pharmacovigilance

Techsol Life Sciences — Fri, 25 Jun 2021 10:33:00 +0000

June 25, 2021
Posted by: Techsol Life Sciences
Category: Pharmacovigilance

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PV Industry Outlook

Pharmacovigilance (PV) is the function in the drug development process that ensures patient safety and release of high-quality medicinal products to the market. Life sciences organisations receive huge volumes of adverse event information from patients, manufacturers, and healthcare professionals to analyse, assess and report it to the authorities in a timely manner. This process of capturing repetitive adverse event data becomes challenging on a day-to-day basis, as it is not only time-consuming but also extremely costly for the organization.

Pharmaceutical companies can leverage latest automation technologies such as artificial intelligence (AI) and machine learning (ML), natural language processing (NLP), and deep learning to eliminate manual PV processes and facilitate faster decision-making.

Automation empowers organizations to recognize greater efficiency, quality of work and the speed at which manual tasks can be accomplished while re-directing valuable resources to focus on higher-order tasks. It also helps in addressing the global requirements of detection, assessment and understanding of drug-related problems including signal detection, risk management, adverse event reporting, and other activities.

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Automation – A Game Changer in PV

With the use of automation Pharmaceutical can realize significant value-add across all the core areas of PV such as literature screening, ICSR reporting, and signal detection in drug safety, pharmacovigilance analytics, and benefit-risk assessment. Repetitive and routine manual tasks such as adverse event case intake, Individual Case Study Report (ICSR) processing, and data quality assurance can be automated and tackled by AI in a refined and seamless way.

The use of advanced technology in PV adds value across the whole spectrum of pharmacovigilance operations starting from AE data management in clinical development; preparation of programmed summary tabulations; and listings for aggregate reporting, social media monitoring, and post-marketing surveillance.

PV automation holds the potential to improve compliance, higher reporting volumes, and speed, which in turn helps companies with quality evidence available for scientific assessment and to expedite decisions about the minimization of risks associated with medicines.

Key Drivers for PV Automation

The volume of adverse event (AE) cases is growing rapidly with increasing disease complexity
Global regulations becoming more complex due to increased regulatory scrutiny
Rising organizational pressure to minimize costs
Regulators evaluating real-world evidence (RWE) sources
Data science and automation evolving for signal detection and case management
Increased focus on risk/benefit analysis and signal management
Need for advanced safety data analytics tools
The Consumer is demanding improved focus on patient centricity
Medicinal product portfolios are increasing in complexity

Shaping the Path Forward with Various Automation Platforms in PV

PV automation tools range from basic to robotic process automation, offering a wide variety of technology solutions that can be employed to drive operational efficiencies across the PV continuum.

Artificial Intelligence (AI)
Machine Learning (ML)
Robotic Process Automation (RPA)
Natural Language Processing (NLP)
Big Data Analytics

These novel automation technologies offer significant opportunities to boost the process of PV with the following benefits:

Reduce the need for outsourcing to multiple service providers
Facilitate cross-functional process integration
Eliminate manual errors that result in poor quality
Increase process efficiency and resource productivity

Role of Automation in Reducing Literature Screening Time

Literature screening is conducted to identify abstracts and articles that provide information on serious and non-serious ICSR reports and risk-benefit assessment of a medicinal product under evaluation.

As part of PV workflow, literature screening is more than just a drug safety regulatory obligation. The insights into safety issues like drug interactions to identify patient safety risks and allow the preparation of critical reports that may have to be sent to regulatory bodies.

This is incredibly time-consuming and labor-intensive work, with the risk of inefficiencies like the same document being viewed multiple times. It requires timely processing of records as it puts market authorization holders (MAH) at risk of non-compliance and regulatory fines.

Automation in literature screening helps identify both new and significant ICSRs of Adverse Reactions and relevant medicinal products’ periodic safety update reports (PSUR).

The use of NLP helps understand the relationship in sentences during literature screening and quickly identifies ADEs from a wide area of sources such as Embase and PubMed.

Automation in literature screening aids in reviewing the medical literature and monitoring the article channel from a single browser interface. It drastically reduces review time by automatically eliminating repeated redundant information.

Decreasing ICSR Case Processing Time using Automation

In PV, ICSR processing is resource-intensive, attributing to the approval of new therapies, evolving regulations, patient support programs and an increase in sources of adverse event reporting through social media and mobile applications. But, it also carries the risk of operational inefficiencies and errors.

There is a tremendous burden of manually processing these adverse event report cases. The advent of robotic process automation (RPA), cognitive computing and ML present a significant opportunity to automate several steps in the ICSR process and thereby reducing the case intake time.

Companies receive cases from different sources such as clinical trials, spontaneous reports and literature in both structured and unstructured formats depending on the source of data being collected. This data is further acknowledged for receipt and checked for duplications. The cases are then reviewed to prioritize based on key factors such as life-threatening, resulting in death, disabling etc. and then the case is assigned to a particular person or workflow for further processing.

Automation with AI can be brought in steps during case intake, acknowledgment of receipt of data, duplicate checks, submissions, distribution and prioritization/triage. ML and NLP can be used for screening digital media, and extracting and classifying data from various source documents. This automation would not only result in reducing the time and costs but also helps eliminate errors and improve overall consistency during information processing.

Most significantly, intelligent automation of the ICSR process will benefit patients by enhancing safety signal detection and risk management.

Enhancing Signal Management Processing through Automation

The signal management process is defined as the set of activities performed to determine whether there are any new risks associated with a medicinal product up on examining ICSRs, aggregated data from active surveillance systems, and literature information.

Signal management processing includes signal detection, analysis and prioritization, evaluation/validation, and signal assessment to recommend a future course of action. It primarily addresses the risk-management strategy.

The signal management system must be compliant, rapid, and efficient. By using an automated system, advanced algorithms will be able to complete most of the cumbersome steps, pertaining to signal detection and evaluation/validation, and other important activities at the adverse event level. As a result, these advanced automation technologies will significantly reduce time, resources and expenses for signal management.

How Techsol’s PV Compier Platform can Enhance and help Companies Transform their PV Processes

Compier is our compliance-driven platform addressing various challenges associated with pharmacovigilance. We at Techsol, help organizations in bringing in automation and regulatory compliance. The platform is engineered with modern technology to facilitate automation-driven process workflows and it enables companies to make informed decisions using actionable insights.

Compier Platform PV Modules we offer

At Techsol, we understand the benefits that these automation tools offer and how our clients can take advantage of them. With highly configurable modules, sponsors and service providers can opt for one or more application modules in varying combinations according to their business need. Every module focuses on addressing a quality or improvising compliance.

Key Platform components

Following are some of the key platform components which enable operational oversight and compliance management across various PV Operations:

Process Alerts & Notifications
Integrated Email Inbox
PVOps Business Intelligence Studio
Process Automation
Audit Trail & Utilities
Cross-Functional System Integrations
Business Workflows
Digitalization of content
Collaboration on tasks and activities

* Compier Interfaces and Integrations

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Factors Influencing the Outsourcing of Pharmacovigilance Processes

Techsol Life Sciences — Wed, 13 Jan 2021 11:53:00 +0000

January 13, 2021
Posted by: Techsol Life Sciences
Category: Pharmacovigilance

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Introduction

Pharmacovigilance is a very important process associated with the gathering, detection, assessment, monitoring and prevention of Adverse Events associated with pharmaceutical products. The immense volume of unstructured information flowing through various channels into the organization also needs to be processed and sent to the relevant Agencies in the prescribed structured format.

As Pharmacovigilance activities are crucial to the pharmaceutical companies, the demand for robust compliance systems and experienced professionals has raised the cost of maintaining the infrastructure needed to support in-house pharmacovigilance activities. So, many companies outsource some of their pharmacovigilance activities to reduce cost and to improve the efficiency of their Pharmacovigilance Systems. Outsourcing the tasks in the Pharmacovigilance processes also provides a flexible solution to the ever-changing demands of the PV team.

Apart from the cost and human resources, the other prominent factors influencing the outsourcing of PV processes are training, technology and changes in regulatory rules.

The Factors Influencing Outsourcing of PV Processes

Now that we have identified the most prominent factors influencing the outsourcing of PV processes, let’s discuss these prominent factors in brief.

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Skilled Resources

Finding the right personnel to maintain and operate the PV processes in-house is a tough ask as there is a dearth of talented and dedicated professionals in many geographical locations. Reaching out to the right people, interviewing them, getting them on board and retaining them is an exercise that many firms are not too keen to take up. Companies find it easier to outsource their PV processes to third party vendors who take care of their PV requirements.

Resources who can manage the entire PV process and also adapt to deal with regulatory and compliance requirements are not easy to find. It is not an easy task, especially for large scale organizations due to the number of required employees. Finding the right resources is challenging task in any type of industry and is even more challenging in the Pharma and Lifesciences industries.

Technology

Technology is an area in which every organization is keen to invest in. Firms want in-house processes to take care of their PV needs. However, using the standard tools can limit the organization’s capability to control the business processes. The compliance factor graph too tends to drop if new technology is not utilized to drive the processes. If companies invest in new technology, they have to deal with the additional responsibilities such as finding the right people and defining the processes around the new technology.

Whenever new technology is implemented, it should be done so by using a set of Standard Operating Procedures in order to optimize the performance of the implemented technology. The SOP’s should always be aligned with the regulatory guidelines. Procuring the right technology is one important factor while the main focus should be on whether the new technology will be in sync with other implementations or not. If not, it would become an information silo. A deep learning curve is required for the usage of the technology and it is not an easy task for the daily users to get hands-on experience for the new technology that is implemented.

Training Employees

Training is a very important factor that determines the success of the PV processes implementation. Making the users understand the configurations and usage policy as per the needs of the organization is crucial. Implementing new technology, new processes etc. can only be achieved by training the existing resources as hiring experienced PV resources is challenging.

Cost of In-house PV Processes

One of the biggest factors influencing the outsourcing of PV processes is Cost. The actual cost involved in implementing Technology, Hiring and Training Resources varies based on multiple variables such as the size of the company, number of PV processes being implemented etc. It is now a proven fact that outsourcing PV processes to a specialized vendor is more cost effective.

Changes in Regulatory Rules

Since the introduction of Good PV Practices (GVPs) in the European Union (EU) in 2012, the industry experienced a huge change in the regulatory requirements applicable to PV.

More stringent regulatory requirements including greater reliance on in-market and real-time monitoring made performing compliance related tasks tougher for PV teams. Globalization and national variations in regulatory frameworks too made adherence to the new regulations difficult. Increasing scrutiny of adverse events by regulators is also strong factor in making PV compliance more daunting and difficult.

Given this scenario and looking at a future likely to include additional requirements and increased emphasis on safety data gleaned from social media and industry sponsored websites, outsourcing of PV operations is a viable solution to several companies as the vendors take care of all the regulatory requirements.

Legend: The above table represents the outsourcing trends of PV Processes.

Most Commonly Outsourced Processes
Not So Commonly Outsourced Processes

The Future of PV Outsourcing

As more and more companies outsource their PV functions, the future is shaping up to facilitate end-to-end outsourcing of PV processes and capabilities. We will see the outsourcing of PV processes not just in case processing, aggregate reports or literature views but also in crucial PV areas such as PCVQA, risk management, signal detection etc.

Thought it cannot be a certainty, we can be sure that end-to-end PV process outsourcing will be a reality in the near future. This can be substantiated by the number of companies opting for PV outsourcing and the increasing worth of the PV Outsourcing market. The worldwide market for PV Outsourcing was worth more than $3.8 Billion in 2019 and is estimated to grow at a yearly rate of 15.8% and reach a value of $10.6 Billion by 2026.
Note: The figures mentioned above are as per Global Market Insights, a global Market Research and Consulting Service provider.

– By Sharath Anil

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With over 12+ years of Drug Safety and Pharmacovigilance experience, we provide end-to-end technical and functional services to manage the safety profile of drugs and devices for sponsors.

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Pharmacovigilance Archives - Techsol Life Sciences

Understanding the Importance of CMC (Chemistry, Manufacturing, and Controls) documents in the Pharmaceutical Product Lifecycle

Understanding the Importance of CMC (Chemistry, Manufacturing, and Controls) documents in the Pharmaceutical Product Lifecycle

Types of CMC Documents

Importance of CMC Documents

Common Challenges with CMC Documentation

Emerging Trends in Managing CMC Documentation

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MoCRA Made Easy: A Comprehensive Guide to Cosmetic Safety Compliance

MoCRA Made Easy: A Comprehensive Guide to Cosmetic Safety Compliance

Facility Registration

Compliance Dates under MoCRA

Suspension of Facility Registration under MoCRA

Product Listing

MoCRA Exemptions for Small Businesses

Person Responsible

Adverse Event Reporting (MedWatch)

Safety Substantiation

Enhanced Labeling Requirements

Key References

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Our Perspectives

Understanding the Importance of CMC (Chemistry, Manufacturing, and Controls) documents in the Pharmaceutical Product Lifecycle

MoCRA Made Easy: A Comprehensive Guide to Cosmetic Safety Compliance

Understanding how Disease Registries can Power Oncology R&D Pipeline and De-Risk Clinical Trials

Best Practices for Signal Management in Pharmacovigilance

What Is A Signal?

What Is Signal Management in Pharmacovigilance?

Signal Management Overview

Challenges in Signal Management

Best Practices for Signal Management

Future Trends in Signal Management

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Aggregate Reporting – Significance, Classification and Challenges

Why Aggregate Reporting?

Classification of Aggregate Reports

Challenges in Aggregate Reporting

Compier Aggregate Reports

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Literature Screening – Process overview, challenges en-route and the scope for automation

Outline of steps involved in the Screening Process

Challenges associated with Literature Screening

Role of automation in improving literature monitoring process

Techsol’s Compier Literature Screening Solution Overview

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How the Trial Master File is Expected to Evolve in the Next Three Years

The Current State of the Electronic Trial Master File (eTMF)

1. Increased Adoption of Artificial Intelligence to Automate eTMF Workflows

2. The Rise of Automated Document Quality Control in the eTMF

3. Orchestrating eTMF Real-Time Collaboration between Clinical Research Sites, Sponsors and Regulators

How We Can Help

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Automation Opportunities in Pharmacovigilance

PV Industry Outlook

Automation – A Game Changer in PV

Key Drivers for PV Automation

Role of Automation in Reducing Literature Screening Time

Decreasing ICSR Case Processing Time using Automation

Enhancing Signal Management Processing through Automation

How Techsol’s PV Compier Platform can Enhance and help Companies Transform their PV Processes

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Factors Influencing the Outsourcing of Pharmacovigilance Processes

Introduction

The Factors Influencing Outsourcing of PV Processes

How We Help Sponsors

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