Pharmacovigilance audits are a crucial component of any pharmaceutical company’s Quality Management System. By measuring the system against its own procedures and against the regulatory guidelines, auditing provides an unbiased assessment of the operational performance and compliance of the Pharmacovigilance system.
The normal flow of audits and inspections starts with a physical visit to the company, but there is another mechanism starting to come into play now by some agencies and companies and these are remote audits and inspections which means that the inspectors will not physically go to the company.
The EMA issued a document on "Distant/virtual pharmacovigilance inspections of MAHs during a crisis situation- Points to consider" in 2013 already, but in the current Corona crisis, this is more actual than ever before.
In this webinar, Dr. Reinhard Nibler will explain the regulatory background and he will show you, together with Dr. Andrea Striebel, how a remote audit can be performed successfully.
1) EXTEDO company introduction
2) Dr. Nibler & Partner company introduction
3) Regulatory background: Dir 2001/83, GVP, ISO 19011
4) Risk based audit strategy under pandemia conditions
5) Alternative audit techniques:
b) Remote audits
6) Strengths and weaknesses of different audit methods
7) Practical exercise of a remote audit
8) Questions & Answers
- Dr. med. Reinhard Nibler, Partner, Dr. Nibler & Partner
- Dr. Andrea Striebel, Senior Business Consultant, EXTEDO
Event Details and Registration
Date: Tuesday, 21 April 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.