Proceedings: DIA 2019 Global Annual Meeting

DIA GAM 2019

Community Meet-Up: Forum of Pharmacovigilance Quality Heads

Elena Popa


n a rapidly changing environment, pharmacovigilance activities ensure that patient safety remain front and center, ensuring—among other things—that information for patients is always accurate. Because it plays a critical role in medicines development, the industry safety and quality departments are also increasingly monitored by Health Authorities through regular inspections. Key Performance Indicators (KPIs) and Quality Assurance checks are scrutinized by inspectors in order to ensure compliance with regulatory requirements.

The Forum of Pharmacovigilance Quality Heads Community Meet-Up focused its discussion on the challenges, the goals, and the areas where industry could work together with health authorities in order to develop common tools.

Key Takeaways

  • Joint Inspections are becoming more common, and there is a need to harmonize the inspection methodology for all authorities.
  • Industry needs more support and guidance to comply with regulatory requirements. Close collaboration may allow for the development of common tools to help address these challenges effectively.
  • Joint audits to assess the pharmacovigilance systems of common service providers could be planned and organized to save costs.
A new item addressed at this Meet-Up was the status of joint inspections by authorities from different regions, such as the joint MHRA-FDA-Health Canada inspection. In general, there was a call to harmonize the inspection processes in order to improve the synergy of the quality systems; one of the examples mentioned were the differences between EMA and FDA with regard to Reference Safety Information (RSI). In addition, the acceptance of a generalized “audit standard certification” by the Authorities during inspections could afford a possibility to decrease companies’ costs burden. The lack of global harmonization regarding pharmacovigilance regulations is putting pressure on companies during inspections and audits. The main recommendation therefore was for industry to work closely with regulators to reach an agreement or create tools that could help simplify the processes before, during, and after inspections.

Health Authority Inspections

Joint Inspections are becoming more common, and there is a need to harmonize inspection methodologies across authorities. A concrete example of joint inspection was a MHRA–FDA–Health Canada inspection. Joint inspection, for example, save time and reduce costs significantly throughout the year. The downside: If the inspected company fails to comply with the requirements of one Authority, it automatically fails the other two Authority inspections as well.

Regulatory Compliance and Quality Oversight Across the Organization

Many questions were raised by industry representatives regarding RSI submission timelines, how to track Risk Management Plan (RMP) submission compliance, best approach to submit the batch cases to the Authorities, and how to communicate late cases properly to the Authorities. There was a general feeling that industry needs more support with and guidance on these issues and that a close collaboration could help with developing tools to navigate the challenges they are facing.

In a changing landscape, companies also need to have quality oversight across the organization. This is related to the different pharmacovigilance functions and their role in monitoring patient safety.

Oversight of Business Partners

Some Health Authorities, such as EMA, highly recommend having in place a system to oversee business partners. In order to avoid inspectional findings, companies are working on risk-based approaches for their partners. Another topic of huge interest in the Community debate was which KPIs the companies put in place with their business partners, and how pharmacovigilance is viewed from an automation perspective.

Many questions remained regarding audits, including how many business partners companies are planning to audit, and how companies can audit each other and not create a financial burden. For companies to save costs but still maintain the partners’ relationships, the forum recommended to plan joint audits to assess the pharmacovigilance systems of common service providers.

Quality Report of the ICSR

Industry representatives pointed to several challenges with assessing the content quality of pharmacovigilance deliverables, products, and causality reports, and determining which methodology to use. These issues were presented as priorities for industry to find ways and tools to simplify processes.

The DIA Pharmacovigilance Community members present at this Meet-Up were determined to work together with the Health Authorities to reach an agreement on how to avoid adding more pharmacovigilance regulations when there is a lack of global harmonization.