Essentials of Safety Medical Writing

Everything you need to know to effectively write safety reports.

会议日程

天 1 2021 年 12 月 02 日

9:00 AM — 9:15 AM

Welcome and Introductions

9:15 AM — 10:30 AM

Session 1: The Big Picture

10:30 AM — 10:45 AM

Refreshment Break

10:45 AM — 12:15 PM

Session 2: The Development Safety Update Report (DSUR)

12:15 PM — 12:30 PM

Refreshment Break

12:30 PM — 1:15 PM

Session 3: Submission Time

1:15 PM — 1:45 PM

Session 4: Workshop: Safety Concerns

1:45 PM — 2:00 PM

Questions and Answers

天 2 2021 年 12 月 03 日

9:00 AM — 9:15 AM

Recap of Day 1

9:15 AM — 10:15 AM

Session 5: The Risk Management Plan (RMP) and Risk Evaluation and Mitigation Strategies (REMS)

10:15 AM — 10:25 AM

Refreshment Break

10:25 AM — 11:55 AM

Session 6: Periodic Postmarketing Safety Reporting (PBRER/PSUR/PADER)

11:55 AM — 12:10 PM

Refreshment Break

12:10 PM — 1:15 PM

Session 7: Safety Writing Skills

1:15 PM — 1:45 PM

Session 8: Workshop: Writing Skills

1:45 PM — 2:00 PM

Questions and Answers Wrap Up