Crafting Effective Scientific Advice Strategies in the EU

Sponsors should always seek scientific advice in the EU. Prospectively engaging with the regulators will help sponsors from two important perspectives…

• You don’t know, what you don’t know!
• Forewarned is forearmed!

Scientific advice is key to designing a development programme to mitigate risks, maximise the probability of success and benefit from fee reductions in the process.

Our webinar provides an in-depth discussion of the scientific advice procedure to help you craft an effective scientific advice strategy for your medicinal product in the EU.

The webinar provides:

1. An introduction to the EMA and the centralised procedure,
2. An overview of national scientific advice,
3. An overview of CHMP scientific advice,
4. A proposed approach to creating a scientific advice strategy,
5. An introduction to different pilot procedures (SNSA, pre-CTA, SAWP-CTCG),
6. A compare and contrast of each scientific advice and pilot procedures,
7. Recommendations for your scientific advice strategy, and
8. A Q&A session.