1 option
Advanced therapies in an evolving regulatory and access environment.
- Format:
- Video
- Language:
- English
- Subjects (All):
- Gene therapy.
- Physical Description:
- 1 online resource
- Place of Publication:
- [Place of publication not identified]: Henry Stewart Talks Ltd, 2026.
- Contents:
- Introduction
- Overview of the presentation
- Overview of current situation in Europe
- Academic involvement in early AT development
- Inbuilt access thinking in all developments of advanced therapies
- Mapping the path ahead
- How to de-risk academic early developments to increase translation via SMEs and pharma
- Select your product carefully: unmet medical need
- EMA tools available to medicines’ developers from academia
- Next generation regulatory: conscious manufacturing
- The changing regulatory-access world
- Legislative finalization and approval process
- Implementing the new EU pharmaceutical legislation
- The compromise document: relevance for advanced therapies
- From orphan to common
- Long-term sustainability
- The moving geopolitical environment
- The changing regulatory-access framework take home messages
- The complete ecosystem with academia at its center as the engine of innovation
- Final thoughts: two coming challenges
- Ackowledgements and financial disclosures.
- Notes:
- Part of the metadata in this record was created with the help of AI Metadata Assistant
The Penn Libraries is committed to describing library materials using current, accurate, and responsible language. If you discover outdated or inaccurate language, please fill out this feedback form to report it and suggest alternative language.