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 discussthe 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‐sized‐
enterprises (SMEs), Technology Transfer Offices (TTO’s).
The presentations will be given in English.
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 willreceive a confirmation ofregistration and a detailed route description
afterwards. The final programme of the workshop and meeting room info will be sent to you in March.