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Sheraton Boston Hotel

Aug 16, 2017 8:00 AM - Aug 17, 2017 5:15 PM

39 Dalton Street, , Boston, MA 02119 , USA

European Regulatory Affairs: Keeping Your Finger on the Pulse of Marketing Authorizations

Agenda

Day 1 Aug 16, 2017

8:00 AM — 8:30 AM

Registration and Continental Breakfast

8:30 AM — 8:45 AM

Welcome and Opening Remarks

8:45 AM — 11:00 AM

Session 1: Drug Legislation and Drug Regulation

11:00 AM — 12:00 PM

Session 2: The Role of Regulatory Affairs During Drug Development

12:00 PM — 1:00 PM

Luncheon

1:00 PM — 2:00 PM

Session 3: The New Pharmacovigilance Regulations

2:00 PM — 3:30 PM

Session 4: Registration Dossier

3:30 PM — 4:00 PM

Refreshment Break

4:00 PM — 5:00 PM

Session 4: Regulatory Procedures of Drug Marketing Authorizations in the EU

5:00 PM — 5:30 PM

Questions and Answers

Day 2 Aug 17, 2017

8:00 AM — 8:30 AM

Continental Breakfast

8:30 AM — 8:45 AM

Recap of Day 1

8:45 AM — 10:45 AM

Session 6: Legal Types of Marketing Authorizations in the EU

10:45 AM — 11:00 AM

Refreshment Break

11:00 AM — 12:30 PM

Session 7: Variations: The Role of Regulatory Affairs After Marketing Authorization

12:30 PM — 1:30 PM

Luncheon

1:30 PM — 2:00 PM

Session 7 (continued): Variations: The Role of Regulatory Affairs After Marketing Authorization

2:00 PM — 3:30 PM

Session 8: Transparency in Drug Regulatory Affairs

3:30 PM — 3:45 PM

Refreshment Break

3:45 PM — 5:00 PM

Session 9: Regulatory Strategy

5:00 PM — 5:15 PM

Questions and Answers

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European Regulatory Affairs: Keeping Your Finger on the Pulse of Marketing Authorizations

Agenda

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