The archiving of Pharmacovigilance data and documents is mandatory according to EMA's "Good pharmacovigilance practices" (GVP Module VI) and several other regulations to stay compliant, but many details need to be considered to do it correctly and efficient.
In this webinar, Dr. Reinhard Nibler will explain the definitions and standards of archiving, talk about the legal background and give advise what should be considered.
Dr. Andrea Striebel will present how archiving can be performed successfully using SafetyEasy PV.
At the end, we will answer your questions in the Q&A session.
1) EXTEDO company introduction
2) Dr. Nibler & Partner company introduction
3) Archiving in Pharmacovigilance
- Definitions and Standards
- Legal background
- Paper versus electronic
- Archivable data formats
4) Demo: How SafetyEasy PV can support your archiving needs
5) Questions & Answers
- Dr. med. Reinhard Nibler, Partner, Dr. Nibler & Partner
- Dr. Andrea Striebel, Senior Business Consultant, EXTEDO
Event Details and Registration
Date: Tuesday, 12 May 2020
10:00 am EDT (New York, Philadelphia)
02:00 pm BST (London, Lisbon)
15:00 h CEST (Madrid, Berlin)
Duration: 60 Minutes
Participation is free of charge.