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.

Agenda

Day 1 Apr 24, 2017

8:00 AM — 8:30 AM

REGISTRATION

8:30 AM — 10:00 AM

SESSION 1: STRATEGY FOR SCIENTIFIC/REGULATORY ADVICE

10:00 AM — 10:30 AM

COFFEE BREAK

10:30 AM — 11:00 AM

GROUP EXERCISE TO REFLECT ON THE TOPICS COVERED IN SESSION 1

11:00 AM — 12:30 PM

SESSION 2: PLANNING, PREPARING AND MANAGING THE MEETING – EMA & FDA

12:30 PM — 1:30 PM

LUNCH BREAK

1:30 PM — 3:00 PM

SESSION 2 CONTINUED: PLANNING, PREPARING AND MANAGING THE MEETING – EMA & FDA

3:00 PM — 3:30 PM

COFFEE BREAK

3:30 PM — 4:30 PM

SESSION 3: WHAT HAPPENS AFTER THE AGENCY MEETING/FEEDBACK

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EU Health Authorities Scientific and Regulatory Advice

Agenda

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