Pharmacovigilance Inspections and Audit activities should verify, by examination and evaluation of objective evidence, the appropriateness and effectiveness of the implementation and operation of a pharmacovigilance system, including its quality system for pharmacovigilance activities.
This webinar will provide guidance on the planning, conduct, reporting, and follow-up of pharmacovigilance (PV) inspections and audits in the EU from the perspective of the inspector or auditor. You will gain insight into the regulatory framework as well as into the concept of inspection and audit from the inspector/auditor perspective. The webinar will also contain examples of inspection/audit findings that might help you to fix potential gaps in your PV system.
Choose between one of 3 sessions available for this webinar on July 28th:
- Session 1: 28 Jul, 6am EDT / 11am BST / 12pm CEST
- Session 2: 28 Jul, 10am EDT / 3pm BST / 4pm CEST
- Session 3: 28 Jul, 2pm EDT / 7pm BST / 8pm CEST
- Regulatory framework applicable to PV Inspections and Audits
- PV Inspection Readiness from inspector perspective
- PV Audit Readiness from auditor perspective
- Examples of Inspection/Audit findings
At the end of the webinar, you will have the opportunity to ask our experts any questions you may have.
About our expert speakers:
Jana Hyankova, MD
Senior PV Director, EU QPPV, UK QPPV
Jana Hyankova is an expert on pharmacovigilance with more than 15 years of working experience from several global pharma companies. Jana joined PrimeVigilance (former PharmInvent) in 2014 and currently holds the position of Senior PV Director in the QPPV Department. She serves as EU QPPV and UK QPPV for several clients and conducts PV audits as requested by clients. Prior to joining PrimeVigilance, she held managerial pharmacovigilance roles at Bristol Myers Squibb and PharmaSwiss SA after acquisition of the company Valeant Pharmaceutical International. Jana has gained her medical education at Charles University in Prague. Outside of PrimeVigilance, Jana is chairing RQA Pharmacovigilance Committee and is also an active lecturer of the RQA, PIPA, ISoP, and Conforum.
Senior Strategic Advisor, EU QPPV, UK QPPV
Zuzana Chomatova is a professional with 14 years of experience in pharmacovigilance gained in regulatory agencies and the pharmaceutical industry. Zuzana is currently working in PrimeVigilance in the position of Senior Strategic Advisor for pharmacovigilance. Zuzana serves as the EU QPPV and the UK QPPV for several clients (MAHs). Prior to joining PrimeVigilance in 2019, Zuzana as the pharmacovigilance inspector at the Czech national agency, built up the procedure for conducting pharmacovigilance inspections and completed a large number of inspections (according to the national inspection programme as well as the EMA inspection programme for CAPs, all of them as a Lead inspector). As a member of the Pharmacovigilance Inspectors Working Group under EMA, she participated in the development of European Pharmacovigilance Guidelines (GVP), Union Procedures on EU pharmacovigilance inspections, and other documents or opinions. Zuzana is also occasionally leading PV audits and gap analysis of PV Systems of the clients and providing PV trainings internally and externally.
If you have any questions about our webinar please feel free to contact us