Complimentary Webinar: The New EU ADR Reporting Rules GVP Module VI, Revision 2

EXTEDO invites you to its complimentary webinar about the new EU ADR Reporting Rules, which implies that Marketing authorisation holders shall submit all serious suspected adverse reactions that occur in the Union and in third countries within 15 days and all non-serious suspected adverse reactions that occur in the Union, within 90 days. This will be coming into effect on 22 November 2017.

During the webinar, Dr. Reinhard Nibler will explain the legal basis of the new reporting rules and its implications on the collection, management and submission of reports of suspected adverse reactions to medicinal products.
Following the theoretical part, Dr. Andrea Striebel will show you how cases can be managed within EXTEDO´s Drug Safety management solution PcVmanager.  

 

Agenda

  1. Legal basis: Dir 2001/83, GVP VI
  2. Information collection
  3. Case validation
  4. Case management
  5. Submission to Eudravigilance
  6. Compliance and Quality
  7. Practical example: Case Management in EXTEDO's PcVmanager
  8. Q&A Session

Speakers

Dr. med. Reinhard Nibler

Pharmacovigilance Consultant and General Manager, Dr. Nibler and Partner

He is specialist in anaesthesia, medical quality manager and TÜV-CERT auditor with several years of expertise in different areas of pharmaceutical industry. He is a regular speaker at national and international conferences and active member in several professional societies. Dr. Nibler is also lecturer for Drug Safety at the Berlin University for Professional Studies.

Dr. Andrea Striebel

Senior Business Consultant, EXTEDO

Before joining EXTEDO in January 2016, Andrea worked in the pharmaceutical industry for more than 11 years. Being a graduate biologist she started her career as a scientist in the pharmacovigilance department. After five years, Andrea took over the team leader position for global drug safety and in 2011 she became QPPV. In her role she was responsible to establish and maintain the global pharmacovigilance system within the company.

Details

Date: Tuesday, 14 November 2017

09:00 am EDT (New York, Philadelphia)
02:00 pm BST (London, Lisbon)
15:00 h    CEST (Madrid, Berlin)

Duration: 60 Minutes

Registration

Click here to register free of charge

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