European Medicines Agency-EuropaBio information day

• Date:
  Thursday, 15 October 2015, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

The third EMA-EuropaBio information day will take place in London. Participants will discuss three main topics: early access scientific and regulatory tools, updates and achievements of orphan medicine development in the past 15 years and challenges ahead, and development considerations of advance-therapy medicinal products. Registration closed.

Documents

Summary report - European Medicines Agency-EuropaBio information day

Participants list - European Medicines Agency-EuropaBio information day

Agenda - European Medicines Agency - EuropaBio information day

Reference Number: EMA/656844/2015

Presentation - European Medicines Agency - focus on the future (Guido Rasi)

Presentation - PRIority MEdicines (PRIME) Support to development of priority medicines for unmet medical needs (Jordi Llinares)

Presentation - Early access tools: accelerated assessment and conditional marketing authorisation (Michael Berntgen)

Presentation - Early access session (Martine Zimmermann)

Presentation - European Medicines Agency adaptive licensing: a tool concept for accelerated access to innovative medicines? (Rob Hemmings)

Presentation - Our first experience with a European Medicines Agency adaptive licensing pilot project (Fabrizia Bignami)

Presentation - The patient perspective: Adaptive licensing (Emily Crossley)

Presentation - Building on 15 years of Orphan legislation: current and future approaches (Stelios Tsigkos)

Presentation - Orphan medicinal products: Challenges faced by companies in implementing the existing guidelines (Robert Morgan)

Presentation - Level of evidence from Orphan designation to European Union marketing authorisation (Laura Fregonese)

Presentation - Good manufacturing practice for advanced-therapy medicinal products (ATMPs) (Rocio Salvador Roldan)

Presentation - Good manufacturing practice considerations for advanced-therapy medicinal products (ATMPs) (Alec Orphanidis)

Presentation - Committee for Advanced Therapies (CAT) considerations for minimally manipulated advanced-therapy medicinal products (ATMPs) and the use of RBA for such products (Metoda Lipnik-Š tangelj)

Presentation - Advanced-therapy medicinal product (ATMP) development challenges: From scientific advice to market authorisation (Peter McArdle)

Presentation - Advanced-therapy medicinal product (ATMP) development challenges: From scientific advice to market authorisation (Lisbeth Barkholt, Caroline Voltz)