National & EU scientific regulatory support mechanisms and initiatives for innovation in drug development (02/05/2016)

Summary:

On 02/05/2016 the famhp organized it’s first workshop for academic research centres/spin‐offs, university hospitals, and small‐ and medium‐sized‐enterprises (SMEs) to illustrate the role and importance of national and European scientific‐regulatory advice as support mechanisms in drug development. The workshop also provided an overview of the innovation support mechanisms and SME‐specific incentives that are currently in place at the level of the European Medicines Agency (EMA). Two case studies highlighted 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. In addition, the workshop also aimed to identify and initiate discussions with the workshop participants which types of guidance and early dialogue mechanisms, other than scientific‐regulatory advice, would be most needed in the future to facilitate and speed up innovation in drug development at the Belgian level.

Documents:

  1. Agenda - National & EU scientific regulatory support mechanisms and initiatives for innovation in drug develompment
  2. Presentation - The famhp and DG Pre-authorisation - key activities in evaluation and approval of innovative drug products at national and EU level(Greet Musch)
  3. Presentation - National Scientific & Technical/Regulatory advice from the famph: current procedures and experience(Christophe Lahorte)
  4. Presentation - The role and importance of European Scientific - Regulatory advice mechanisms - incentives for SME's & academics(Dieter Deforce)
  5. Presentation - Case study 1: How can scientific advice be helpful in drug development? - experience from a SME(Vincaine Wouters)
  6. Presentation - Case study 2: The hurdles of translating basic academic research into applied clinical research(Ilse Sienaert)
  7. Presentation - EU scientific regulatory support mechanisms and initiatives for innovation in drug development: the EMA perspective (Zahra Hanaizi)
  8. Presentation - Future famph initiatives to support drug development and innovation from SME's and academics: Questionnaire presentation (Karolina Szlufcik)

 

Last updated on 17/07/2017