Fees : 150€ for the Members and 350€ for the non Members.

PROGRAMME

Thursday 15 March 2012 - De Montil, Affigem

The conference will clarify us on two main topics related to paediatric development.

This afternoon session starts with a lesson for the future by analysing the past. Five years after the implementation of the Paediatric regulation, the time has come to make an intermediate analysis. We will hear first-hand about the extensive experience of the PDCO (EMA) and have an actualized viewpoint on how the Paediatric Committee plans to continue their effort in the future.

The two next presentations will focus on the importance of the Non-Clinical part in a paediatric development. Both the viewpoint from an assessor at the FAMHP, and an insight on how the industry copes with some specific requirements will be presented.
The last presentation covers various issues encountered by companies when introducing a PIP or claiming the SPC extension and proposes some possible practical ways to resolve them.

13.30 – 13.45 Session introduction
Marc Benijts, BRAS Executive Manager

13.45 – 14.15 PDCO, where are we heading to?
Daniel Brasseur, Chair Paediatric Committee (PDCO), EMA London - FAMHP and Childrens Hospital Queen Fabiola, Brussels, Belgium

14.15 – 15.00 Non Clinical support to paediatric drug development.
Jacqueline Carleer, Safety Assessor, Research and Development, Federal Agency for Medicines and Health Products (FAMHP), Belgium, Alternate member of the Paediatric Committee (PDCO)

15.00 – 15.30 Coffee

15.30 – 16.00 An industry approach on Juvenile toxicity testing.
Graham Bailey, ETS President, Senior Research Fellow (Reprotox) Toxicology and Pathology Drug Safety Sciences Janssen Pharmaceutica N.V.

16.00 – 16.45 Legal constraints and proposals to address them
Geneviève Michaux (Counsel), Covington & Burling LLP, Belgium

16.45 – 17.15 Panel discussion

A “must attend” seminar for professionals working in national, EU and International Regulatory Affairs and colleagues from Development, Clinical Research, Project Management, Legal & Patent Departments