Science Researcher Update: Spotlight on Meetings, Conferences, and Events

DIA & TOPRA 2015, Workshop on Adaptive Pathways

Posted on May 22, 2015 5:17:00 AM

Workshop - Brussels, Belgium
Adjusting the route to the market is vital to support innovation and timely approvals for products that could cover unmet or high medical needs. However, what remains unclear is how to shape regulatory strategy to overcome the barriers and whether the evidence gathered for authorisation marries up with the health technology assessment (HTA) strategy. Also the bottlenecks in bringing products onto the market and legislative frameworks at national level are of particular interest. The workshop aims to look into both the regulatory hurdles as well as discuss improvements in market access based on evidence from recent years and the situation in European countries. Insights from experts from both regulatory as well as market access side are brought to the table, connecting all stakeholders.
Registrations will be done through TOPRA website. More information and a detailed agenda will be available soon.
The workshop aims to discuss following key topics:
Current regulatory framework for adaptive pathways and its evolvement How to use adaptive pathways for new products – experiences from professionals EMA adaptive licencing pilot project HTA approval for conditionally approved products in European countries – status quo Additional evidence generation – how to tackle the challenges? Political and public perception of limited evidence on safety and/or efficacy US and EU frameworks – completely incompatible?
Organization: DIA EMEA
30th June 2015 at 06:00 to 18:00 (GMT+02:00) Minsk
Hotel Pullman Brussels Midi
Place Victor Horta 1, 1060, Brussels, Belgium
If you'd like to ask a question or post a comment about this talk please do so below.
This seminar posting is brought to you by Biotechnology Calendar, Inc. providing access to research information and research tools for nearly 20 years. Visit our Science Market Update Blog for current science funding and market information or see our schedule of upcoming science research laboratory product shows.

Tags: June, Medical Research, Workshop, 2015, Belgium, Brussels, Conference, Drug Development

This meeting information is brought to you by Biotechnology Calendar, Inc

We connect researchers with the tools they need to succeed. 

Get 2020 Schedule

sell more lab supplies