14 October 2010 at 9:15 a.m.

Location: Sheraton Rogier

WARNING: (new rule in order to comply with the general tendency of respecting the Earth and the environment).
As from now on, binders with copies of the slides will no longer be disseminated the day of the symposium. The presentations will be at your disposal (if we get these in time) on our website 10 days before the event. Nevertheless a writing pad will be handed over to you at the welcome desk together with the agenda of the day and the participants list. Many thanks for your understanding.

PROGRAMME

08.30   REGISTRATION & COFFEE

   09.15 Welcome Address
               Pieter De Pourcq

    09.30 EMA Road Map 2015
               Noël Wathion

Referrals

    09.50 Regulatory framework for Referrals to the CHMP
               Zaide Frias

    10.10 CMDh-referrals and national implementation of referral opinions  
               Sophie Colyn

10.30   COFFEE BREAK           

    11.00 Referrals: an industry perspective
               Anne De Bock

    11.20 Questions & Answers

Topics of special interest 

    11.50 New biomarker qualification process                                                                                      Dieter Deforce

    12.20 Paediatric regulation: experience with Art 45  and 46 
               Truus Janse-de Hoog

12.50   LUNCH                        

Vaccines

   14.00 Regulatory Framework for vaccines
              Pieter Neels

   14.20 EU perspective on public health aspects of vaccines                              
              Antoon Gijsens

   14.40 Vaccines: an industry perspective
              Frank Vandendriessche

   15.00 Questions & Answers

15.30    COFFEE BREAK

Topics of special interest

   16.00 Experiences with the revised variations regulation 
                Iris Geussens

   16.30 Pharmaceutical Package
               Annabelle Bruyndonckx

    17.10 Closing Remarks 
               Pieter De Pourcq

17.30         COCKTAIL