Join regulatory and industry leaders at the only Europe-wide healthcare regulatory affairs conference with comprehensive programmes covering medical technologies, human and animal medicines –held by TOPRA in partnership this year with the Swedish MPA in Stockholm from 1–3 October 2018.
Get important updates by speakers from:
- The European Medicines Agency (EMA), including Executive Director Guido Rasi
- The Heads of Medicines Agencies (HMA), including Chair Thomas Senderovitz
- Representatives from the European Commission.
- Multiple notified bodies and over 30 national agencies, including the Swedish Medical Products Agency, the British Medicines and Healthcare products Regulatory Agency (MHRA), the Dutch Medicines Evaluation Board (MEB) and the German Paul Ehrlich Institute (PEI).
Some of the key subjects this year will include:
- EMA/HMA European Network Strategy: halfway to 2020 – achievements, challenges and obstacles
- Implementation of medical device and IVD regulations
- Updates on Brexit
- Cooperation between medicinal products and medical devices
- Early access schemes, HTA and market access
- International collaborations: the work of ICMRA, EMA collaborations and WHO’s 50th anniversary
- Clinical evidence and post-market surveillance under the new MDR
- CT regulation – portal pilot
- Advanced therapies for humans and animals
- CMC updates – paediatric formulations and the evolving CMC landscape in China