EU Health Authorities Scientific and Regulatory Advice

NEW OFFERING! The course is built up as a dialogue between industry and regulator perspective and will teach you what authorities pay attention to, what inquiries they make and what they expect to hear from sponsors.

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SESSION 1: STRATEGY FOR SCIENTIFIC/REGULATORY ADVICE

Session Chair(s)

Birka Lehmann, MD

Senior Expert Drug Regulatory Affairs

Birka Lehmann, Germany

Trine B. Moulvad, MSc

Global RA, Medical Documentation and R&D QA

Lundbeck, Denmark

Finding the right strategy for scientific advice is the most important task of the whole process. There are multiple bodies offering advice, timing of advice vary and there are various intended outcomes, which depends on the stage of development.
In this session, the participants will discuss the following:

Whether to seek scientific advice or not
When is the right time to seek Scientific/Regulatory Advice
Types of Scientific/Regulatory Advice EU and US
Which agencies? Focus on EU and US
How to select the EU route for scientific advice: EU CHMP or National

Speaker(s)

STRATEGY FOR SCIENTIFIC/REGULATORY ADVICE

Birka Lehmann, MD

Birka Lehmann, Germany

Senior Expert Drug Regulatory Affairs

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EU Health Authorities Scientific and Regulatory Advice

SESSION 1: STRATEGY FOR SCIENTIFIC/REGULATORY ADVICE

Session Chair(s)

Birka Lehmann, MD

Trine B. Moulvad, MSc

Speaker(s)

STRATEGY FOR SCIENTIFIC/REGULATORY ADVICE

Be informed and stay engaged.