IMB Pharmacovigilance/Safety-based conference - 07 November 2008
The IMB will hold a Pharmacovigilance/Safety-based conference on Friday 7th November 2008 at the Crowne Plaza Hotel, Santry from 09.00 – 16.00hrs.
Aims of the Seminar
Topics that will be addressed include Risk Management Plans, Periodic Safety Update Reports, Monitoring of Compliance with Pharmacovigilance Obligations and Pharmacovigilance Inspections, EudraVigilance and Electronic Reporting
Invited speakers from the European Medicines Agency (EMEA), the Netherlands Medicines Evaluation Board (MEB) and Medicines and Healthcare Products Regulatory Agency (MHRA), will be in attendance, in addition to IMB speakers and staff.
Click on the link below for a detailed agenda
IMB PV Info Day Final Agenda Nov 2008
Who Should Attend
Fee & Venue Details
Enquiries regarding this event can be directed to Karen.Dooley@imb.ie
To attend the event please complete the registration form and payment and return to Karen Dooley.
Details of the venue and directions can be found on the website
Presentations from the event are now available for download:
Presentation 1: Risk Management in the EU:Concept and Components - Dr. Xavier Kurz - European Medicines Agency (EMEA)
Presentation 2: Risk Management in Practice - Kevin Blake - Irish Medicines Board
Presentation 3: PSUR Assessment – Practical Issues - Elaine Breslin - Irish Medicines Board
Presentation 4: Periodic Safety Update Reports Synchronization and Work-Sharing - Dr W.F.(Pim) van der Giesen Medicines Evaluation Board The Netherlands
Presentation 5: Surveillance-related Activities in Pharmacovigilance - Almath Spooner - Irish Medicines Board
Presentation 6: Overview of Experience with Pharmacovigilance Inspections - Carrie Scott - MHRA
Presentation 7: Compliance Monitoring by the Irish Medicines Board - Deirdre O’Regan - Irish Medicines Board
Presentation 8: Eudravigilance/Electronic Reporting Update on Requirements and Experience - Ms. Leigh-Anne Carney - Irish Medicines Board