Samuele Di Lascio -

From 12th till 14th of October RPN exhibits at the TOPRA Annual Symposium which will be held in Berlin at the Maritim ProArte Hotel.

You are warmly welcome to visit our booth (n. 13) and discuss with us current projects as well as potential future collaboration.
If you want to agree on a specific time for the meeting, please contact Dr. Anita Falezza: a.falezza@regulatorypharmanet.com

The TOPRA’s Annual Symposium, – covering pharmaceuticals, veterinary medicines and medical devices – is the largest forum for European regulatory professionals to meet up, discuss current regulatory issues and debate future plans for regulation.

During the Symposium, participants will have the opportunity to discuss and understand proposed regulations and other issues affecting the regulatory roles.

Topics discussed will include the following:

  • Accelerating drug development – What is the regulatory role in delivering medicines more quickly to patients?
  • Implementation of the new clinical trials Regulation – Are we on the right track?
  • Scientific (regulatory) advice and HTA advice – How best to talk to each other
  • Globalisation of pharmaceutical regulation – What do agencies discuss behind closed doors?
  • Mutual recognition/decentralised procedure (MRP/DCP) – What is working well and what challenges remain?
  • Drug-Device Combination Products – Regulatory challenges and importance of usability and human factors considerations
  • Biosimilar medicines
  • The Pharmacovigilance Regulation – 3 years into implementation: challenges and opportunities
  • Availability of medicines – How do new medicines impact the supply of established and essential medicines?
  • The New EU Device Regulations – Impact on Notified Bodies and industry
  • Software as a medical device
  • Vigilance
  • Clinical evaluations and clinical investigations

 

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