アジェンダ
8:00 AM — 8:30 AM
8:30 AM — 8:45 AM
Welcome and Opening Remarks8:45 AM — 11:00 AM
Session 1: Drug Legislation and Drug Regulation11:00 AM — 12:00 PM
Session 2: The Role of Regulatory Affairs During Drug Development12:00 PM — 1:00 PM
1:00 PM — 2:00 PM
Session 3: The New Pharmacovigilance Regulations2:00 PM — 3:30 PM
Session 4: Registration Dossier3:30 PM — 4:00 PM
5:00 PM — 5:30 PM
Questions and Answers8:00 AM — 8:30 AM
8:30 AM — 8:45 AM
Recap of Day 18:45 AM — 10:45 AM
Session 6: Legal Types of Marketing Authorizations in the EU10:45 AM — 11:00 AM
12:30 PM — 1:30 PM
2:00 PM — 3:30 PM
Session 8: Transparency in Drug Regulatory Affairs3:30 PM — 3:45 PM
3:45 PM — 5:00 PM
Session 9: Regulatory Strategy5:00 PM — 5:15 PM
Questions and Answers