PHARMACOVIGILANCE SESSION 5 DECEMBER 2017
NL/FR/EN speaking – Slides in English
Programme and Speakers:
13:30 Session introduction Noëlla Heyman, BRAS Education Group
13:35 Pharmacovigilance Programme Update
Overview 5Y new legislation/New Topics
PV structure at FAMHP (organizational chart PV Unit)
Speaker TBD, FAMHP
Eudravigilance, Katrien Bernaert, FAMHP (NL)
Signals and its management, Sophie Goethals, FAMHP (NL)
PRAC 5 years experience, Laurence Defays, FAMHP (EN)
14:55 Coffee Break
15:15 PHARMACOVIGILANCE INSPECTIONS
5 years implementation of the new legislation: "most encountered issues by Inspection"
Non-limitative list of topics
Figures from FAMHP re 5Y inspections
Highlighting differences between EU QPPV vs LCP PV inspections: areas of focus
Do's and Don'ts
Tips and Tricks
Nele Matthijs, FAMHP (EN)
16:30 Questions and Answers, Noëlla Heyman, BRAS Education Group
16:45 End of session, Annabelle Bruyndonckx, BRAS Education Group
Registrations through our website. (www.bras-org.be)
For registration you click on the line of the session in “Future courses and events” on the Home Page and then sign up. If you are not yet registered on the website you will be asked to do so. The system will send you a confirmation of registration with payment modalities by return mail.
If you need more assistance please contact Brigitte at email@example.com or call her on 02.757 06 29.
Fees: BRAS member 150€ - Non-BRAS member 350€
It is understood, to be admitted to the session, that the fees have been pre-paid. In case of cancellation after 27 November 2017 or no-show, the fees are due and will be invoiced.
Program and speakers
If you need more assistance, please contact Brigitte Frenay at firstname.lastname@example.org or call her on +32 2 757 06 29.
It is understood, to be admitted to the session, that the fees have been pre-paid. In case of cancellation after 27/11/2017 or no-show, the fees are due and will be invoiced.
05 December 13:30
De Montil, Moortelstraat 8 - 1790 Affligem