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FAMHP Active partner in the EU regulatory framework Supporting innovative drug development

FAMHP Active partner in the EU regulatory framework Supporting innovative drug development Greet Musch BRUSSELS, 9 September 2017.

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FAMHP Active partner in the EU regulatory framework Supporting innovative drug development

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  1. FAMHP Active partner in the EU regulatory framework Supporting innovative drug development Greet Musch BRUSSELS, 9 September 2017

  2. The FAMHP: mid-size agencywith full competencies(scientificadvice, clinical trials, marketing authorisations, vigilance, inspections of medicines for human and veterinary use) Significantinvestment in the EU regulatoryframework at the regulatory, scientific, policy-making level 35delegatesat EMA/the HMA 70scientificinternal experts: multidisciplinary, international expanded database of 800external experts Special focus on access to innovation Unmet Medical Need (UMN) and linkwith Health Technology Assessment (HTA) medical devices, cells and tissues 1. Strategy of the FAMHP (1/2)

  3. UMN (@ EU Commission STAMP; @ HMA working group Access to innovation) Clinical trials EU CTR coordination group (EU Commission, EMA, the HMA) the CTFG, Expert group on clinicaltrials EU Network training Centre National Innovation Office SAWP (multinational assessment teams) CHMP (Prime), the PDCO, CAT and PRAC Spearheads Vaccines Early Phase Development 1. Strategy of the FAMHP (2/2)

  4. 2. Focus on early access to innovation: clinical trials Approved Trials (2014-2016) per therapeutic area: # trials BE, EU 12% of the trials in EU are performed in BE 22% Phase I trials Oncology, CNS, viral diseases

  5. Ratio of approved trials (2014 - 2016) per therapeutic area, BE vs. EU and per capita Trials above the red line are better than the EU average

  6. Belgium vs. Europe

  7. EU landscape

  8. Profile of trials and populations

  9. Commercial vs. noncommercial

  10. 3. Focus on early access to innovation: scientific advice

  11. 3. Focus on early access to innovation: national scientific advice

  12. 3. Focus on early access to innovation: national scientific advice (applications validated 2015 - 2016)

  13. 3. Focus on early access to innovation: scientific advice at SAWP 2012-2017: 45 SAWP advices provided by the BE team (30%)

  14. 3. Focus on early access to innovation: PRIME The FAMHP in the top 5

  15. 4. Marketing authorisation: BE rapporteurships 2012-2017: 17 applications for vaccines via the centralised procedure received @ EMA: BE @ CHMP: 7 rapporteurships, 3 co-rapporteurships, 5 peer reviews BE @ PRAC: 7 rapporteurships, 2 co-rapporteurships

  16. 5. Spearhead Early Phase Development • Regulatoryandscientificadviceconcerningearlyphase trials • Clinical Trial attractiveness: network of well knownphase I centers, recruitinghealthyvolunteers • Stablenumber of phase I and FIH clinical trials • Phase I centers allinspectedfor GCP andifproducingIMP’salsofor GMP

  17. 5. Spearhead Early Phase Development • Accreditation of Phase I centers on voluntary basis • Alsorecognisedclinical centers recruitingpatientsintoearlyphaseclinical trials • Exploratoryclinical trials • Participation at nationaland EU level in advices, draftingand training (SAWP, draftinggroup FIH GL at EMA, the ANSM CSST Rennes, EU NTC)

  18. 5. Spearhead Vaccines A Belgiannetworkof four core expert activities, each embedded withinannationalandinternationalnetwork

  19. 5. Spearhead Vaccines • Point of referenceforregulatoryandscientificadvice at European andnational level • Clinical Trial attractiveness: network of well known vaccine clinical trial centers, including human challenge unit • Leadingrole at EMA CHMP and PRAC forrapporteurship of new marketing authorisation (including first PRIME vaccine evaluation) • Point of referenceforGxPinspections (includingthirdcountriesinspection) • Representation in nationalandinternalcommitteesandworkinggroups (EMA Vaccines working party, FDA, WHO Sage, CEPI …) • Scientificandregulatory expertise: network of internalandexternalexpertise (universities and research centers, government institutions)

  20. 6. Conclusions • Solid EU regulatorynetwork HMA-EMA is key. • The FAMHP is fullyengaged in thisstructureand philosophy. • The FAMHP fullysubscribesthenecessitytostronglyinteractwith universities and research centers and the pharmaceutical industry (national and global). • The FAMHP recognisesthestrengths of thedifferent agencies (i.e. spearheads and multinational teams). • The FAMHP willconsolidatethe impact of the Brexit • (additional workload/opportunities).

  21. Federal Agency for Medicines and Health Products – FAMHP Place Victor Horta 40/40 1060 BRUXELLES tel. + 32 2 528 40 00 fax + 32 2 528 40 01 e-mail welcome@fagg-afmps.be www.afmps.be Contact

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