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WORKSHOP “National & EU scientific regulatory support mechanisms and initiatives for innovation in drug development”

May 2, 2016 @ 12:00 am - 6:00 pm

bannière workshop 1000x297

The federal agency of medicines and healthcare products (famhp), DG Pre‐Marketing Authorization organizes an
interactive workshop to illustrate the role and importance of national and European scientific‐regulatory advice
as support mechanisms in drug development performed by academic research centres/spin‐offs, university
hospitals, and in small‐ and medium‐sized‐enterprises (SMEs). This workshop will also provide an overview of the
innovation support mechanisms and SME‐specific incentives that are in place at the level of the European
Medicines Agency (EMA). Two case study sessions are foreseen to highlight and discuss the different hurdles and
challenges that investigators from academia/university hospitals and SME’s are facing during the transition from
basic academic research into clinical research. Finally, the workshop also aims to identify and discuss with the
audience which other guidance and early dialogue mechanisms would be most needed in the future to facilitate
and speed up innovation in drug development at the Belgian level.

Main target audience: Academic research centres/spin‐offs, university hospitals, small‐ and medium‐sizedenterprises
(SMEs), Technology Transfer Offices (TTO’s).


This workshop will be held at EUROSTATION II building (Place Victor Hortaplein 40, 1060 Brussels – in front of
the railway station Brussel‐Zuid/Bruxelles‐Midi) in meeting room “Espace Bara”. At the ground floor of the
building, you will need to register and get a batch from the reception desk after which you need to follow the
workshop’s signalisation to the first floor where we will welcome you in the meeting room “Espace Bara”.
The workshop is an initiative of the famhp’s Scientific‐Technical Advice & KM unit from the DG Pre‐Marketing

How to register?

Please send an e‐mail to staworkshop@fagg‐afmps.be mentioning your name, institute/company name, address,
phone number and e‐mail address. You will receive a confirmation of registration and a detailed route description
afterwards. Participation to the workshop is free of charge.


  • 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


May 2, 2016
12:00 am - 6:00 pm
Event Category:




Place Victor Horta 40/40 , Brussels, 1060
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