アジェンダ
9:00 AM — 9:15 AM
Welcome and Introductions9:15 AM — 10:30 AM
Session 1: The Big Picture10:30 AM — 10:45 AM
10:45 AM — 12:15 PM
Session 2: The Development Safety Update Report (DSUR)12:15 PM — 12:30 PM
12:30 PM — 1:15 PM
Session 3: Submission Time1:15 PM — 1:45 PM
Session 4: Workshop: Safety Concerns1:45 PM — 2:00 PM
Questions and Answers9:00 AM — 9:15 AM
Recap of Day 110:15 AM — 10:25 AM
10:25 AM — 11:55 AM
Session 6: Periodic Postmarketing Safety Reporting (PBRER/PSUR/PADER)11:55 AM — 12:10 PM
12:10 PM — 1:15 PM
Session 7: Safety Writing Skills1:15 PM — 1:45 PM
Session 8: Workshop: Writing Skills1:45 PM — 2:00 PM
Questions and Answers Wrap Up関連イベント
オンライン
Register for this On-demand Training Course to learn about benefit-risk assessment methods and how to incorporate the patient perspective.
| 会員価格： | 非会員価格： | |
|---|---|---|
| Virtual Event Price | $750.00 | $1,075.00 |
オンライン
This online course provides information on planning a business outsourcing model, best practices for selecting and managing providers, and regulatory authority expectations for pharmacovigilance agreements.
| 会員価格： | 非会員価格： | |
|---|---|---|
| Virtual Event Price | $220.00 | $270.00 |