B5 New regulatory approaches to accelerate access to medicines
Thursday 1 September 2016
Hilton Buenos Aires : Atlantico C, 3 hours
Organised by the FIP Industrial Pharmacy Section and the FIP Social and Administrative Pharmacy Section
Simultaneous translation in Spanish
Regulatory agencies are increasingly putting effort into reducing time to approval and reimbursement of new medicines by offering expedited review and development programmes. This approach is particularly relevant for treatments of serious conditions with an unmet medical need, and involves balancing the importance of timely patient access with the need for adequate, evolving information on a medicine’s benefit/risk profile.
At the conclusion of this knowledge-based session, participants will be able to:
- Identify the potential impact of accelerated access to new medicines — Risks, costs, benefits, etc.
- Describe the different tools regulatory agencies offer to accelerate access to medicines
- Identify the benefits and risks to the patient resulting from accelerated licensing
- Describe approaches to fast development of therapies in emergency situations.
Gabrielle Wiederkehr (Access Regulatory Consulting, Switzerland) and Ola Al Ahdab (Ministry of Health, United Arab Emirates)
1) ANVISA: Ways of granting rapid access of emerging therapies to Brazilian patients
Balbiana Verazez Sampaio Oliveira (ANVISA, Brazilian Health Surveillance Agency, Brazil)
2) Novel approaches to accelerate access to innovative medicines: catalysers and challenges
Ola Al Ahdab (Ministry of Health, United Arab Emirates)
10:20 – 10:40 Coffee/tea break
3) Regulatory tools in the USA to accelerate access to innovative medicines - an industry perspective Hermann Schulze (Sucampo AG, Switzerland)
4) The European perspective: Accelerating access to medicines by novel regulatory tools as well as early collaboration with HTA-bodies
Pär Tellner (EFPIA, Belgium)