EVENTS

fagg Workshop “National & EU scientific regulatory support mechanisms and initiatives for innovation in drug development"

Date:
02/05/2016
Location:
fagg, Eurostation II Place Victor Horta 40/40 B - 1060 Brussels

De eenheid Wetenschappelijk-Technisch Advies & Kennismanagement van het federaal agentschap voor geneesmiddelen en gezondheidsproducten (fagg) nodigt alle geïnteresseerden graag uit voor de interactieve workshop “National & EU scientific regulatory support mechanisms and initiatives for innovation in drug development” op maandagmiddag 2 mei 2016 in de kantoren van het fagg in Brussel. De workshop is volledig kosteloos.

 

 

Het programma :

12.00 – 13.00: Registration and walking lunch
13.00 – 13.15: Welcome & introduction
Greet Musch, general director DG Pre-Marketing Authorisation, famhp
13.15 – 13.45: The famhp and DG Pre-authorization – key activities in evaluation and approval of innovative drug products at national and EU level
Greet Musch, general director DG Pre-Marketing Authorisation, famhp
13.45 – 14.15: National Scientific & Technical/Regulatory advice from the famhp: current procedures and experience
Christophe Lahorte, head of scientific-technical advice & KM unit, famhp
14.15 – 14.45: The role and importance of European Scientific-Regulatory advice mechanisms – incentives for SME’s & academics
Dieter Deforce, Director of the Laboratory of Pharmaceutical Biotechnology, Faculty Pharmaceutical Sciences, UGent and SAWP member
14.45 – 15.15: Case study 1: How can scientific advice be helpful in drug development? – experience from a SME
Vinciane Wouters, Director Regulatory Affairs, Promethera Biosciences
15.15 – 15.30: Questions and Answers
Moderator: Christophe Lahorte, head of scientific-technical advice & KM unit, famhp
15.30 – 15.45 Coffee break 
15.45 – 16.15: Case study 2: The hurdles of translating basic academic research into applied clinical research
Ilse Sienaert, Innovation Manager, KU Leuven Research & Development
16.15 – 16.45: EU scientific regulatory support mechanisms and initiatives for innovation in drug development: the EMA perspective
Zahra Hanaizi, Scientific officer, PRIME coordinator, Product Development Scientific Support Department, European Medicines Agency
16.45 – 17.15: Future famhp initiatives to support drug development and innovation from SME’s and academics: Questionnaire presentation
Karolina Szlufcik, scientific file manager, scientific-technical advice & KM unit, famhp
17.15 – 17.45: Questions and Answers
Moderator: Christophe Lahorte, head of scientific-technical advice & KM unit, famhp
17.45 – 18.00: Closing remarks and the way forward
Greet Musch, general director DG Pre-Marketing Authorisation, famhp

Bekijk hier de volledige uitnodiging