National Symposium 2012

Date : Thursday 18 October 2012

Location : Sheraton Rogier

Speakers : FAMHP + Industry - Academy - Patients Group

AGENDA

08.30 REGISTRATION & COFFEE

09.00 Welcome Address
Kuo-Wei Chan

09.15 Setting the scene
Xavier De Cuyper

I. Research & Development

09.30 Clinical Trials: From Directive to Regulation
The new CT regulation (impact assessment)
The renewed legislation at national level (law 7 may 2004)
The new structure of the R&D department, objectives 2013-2014
Greet Musch - Kristof Bonnarens

II. Marketing Authorisations

10.10 Variations and article 34: practical aspects
Update of the Variation regulation: what is new?
Notification article 34: implementation rules
Iris Geussens

10.40 COFFEE BREAK

11.00 eSubmission : reflection
Regulated Product Submission: status and future evolution. What is in it for me ?
New EU validation criteria for NeeS and eCTD: impact Belgian NeeS Checker
Common EU Submission Platform  - Cesp - extended pilot.
Pieter Vankeerberghen

III. Distribution and Delivery

11.40 Impact of new GDP Guideline and Counterfeit Directive on Distribution
Ethel Mertens – Philippe De Buck

12.30 Q&A
Moderated by Dimitry Christiaens

13.00 LUNCH

IV. Pharmacovigilance: long term vision

14.00 Pharmacovigilance: long term vision
Thierry Roisin

14.15 PV legislation: implementation – transition – first experience
Jean-Michel Dogné

15.00 Patients platform
François Houÿez

15.30 COFFEE BREAK

V. Proper Use of Medicine

16.00 Advertising of medicinal products to the
public using social media tools.
Marie-Louise Bouffioux

16.15 Other considerations to be taken in account
by pharmaceuticals companies when using
social media tools.
Annabelle Bruyndonckx

16.45 Q&A
Moderated by Annabelle Bruyndonckx

17.15 Closing remarks
Kuo-Wei Chan

17.30 COCKTAIL


Fees : 575€ for BRAS Members and 765€ for non BRAS Members