Are You Thinking About Pharmacovigilance Inspection Readiness?

Pharmacovigilance (PV) inspections are increasingly challenging, whether in small start-ups with limited resources or in big pharma organizations with complex contractual arrangements and diverse products.  From process and documentation to PV systems and tools, you must be ready to address detailed inspection requests from regulatory authorities across the globe.

Here are some questions for you to consider:

  • Do you have subject matter experts who are ready to talk with inspectors about your database configuration, validation package, and security control?
  • Are your PV contracts up to date and are you compliant with the commitments in those contracts?
  • Are roles and responsibilities clearly defined cross-regionally for inspection support and involvement?
  • Is your PV team prepared to answer questions and provide supportive documentation on your systems and processes?
  • Are you keeping abreast of new PV guidance and regulations to ensure compliance?

If you answered no to any of these questions, then you are not alone.  Today’s post should get you thinking about inspection preparedness as it relates to 3 hot topics in the PV space.

1. Safety Database Management:

Regulators are focusing significant inspection time on electronic PV systems and tools.  They want to know the history of your system, how it’s utilized and maintained, and confirm it’s properly validated for use.  Inspectors also want to ensure you have oversight of vendors managing any systems on your behalf.  In particular, safety database configurations are critical to the business.  Incorrect or incomplete configuration of products, licenses, studies, or reporting rules could result in late submissions to regulatory authorities, non-compliance with contracts, and quality-related findings during an inspection.  A PV system health check might be in order to ensure your system, as well as the processes supporting them, is robust.

2. Data Privacy:

The EU General Data Protection Regulation (GDPR) serves to protect the data and privacy of all individuals in the EU.  This regulation became enforceable on 25 May 2018.  For companies who process and control personal EU data, key components include appointing a data protection officer, data minimization and purpose limitation, pseudonymization and encryption of data, as well as adequacy requirements for transfer of data to non-EU companies.  To avoid hefty monetary penalties, you’ll need to perform an impact analysis and consider changes to your PV business practices as well as your safety system.

3. EudraVigilance Monitoring by MAHs:

The EudraVigilance Data Analysis System (EVDAS) is a web-based tool that allows Market Authorization Holders (MAHs) to access a defined set of ICSR data elements for medicines for which they hold a marketing authorisation in the European Economic Area (EEA).  For a pilot period of one year starting on 22 February 2018, marketing authorisation holders are required to monitor EudraVigilance data and inform the Agency and national competent authorities of validated signals, only for active substances included in the list of medicinal products under additional monitoring which came into effect on 22 November 2017.  To maintain reporting compliance, it’s important to have a defined process in place to manage the use of this tool as well as the data from it.

These are just a few areas to review for PV inspection readiness and there are certainly many more to consider.  Remember that inspections may be triggered for many different reasons such as safety or compliance matters, pre-approval of a product, a new MAH, an MAH who has been involved in a merger or takeover, or even for a change to your PV system.

Daelight Solutions is ready to help you navigate your inspection readiness activities.  We can setup a mock inspection, perform a gap analysis of your processes, conduct a PV health check of your safety database, or even develop procedures where a gap has already been identified.  Daelight Solutions will work with you to clearly define your project needs and will bring seasoned and skilled individuals to assist in meeting your objectives.  We hope this post got you thinking about PV inspection readiness and we hope contacting Daelight Solutions to help is now at the top of your list!