The CHMP Meeting Survival Manual (e-book)
Table of Contents
Introduction
Chapter 1: Overview of the CHMP Timeline and Key Meetings
Chapter 2: Preparing for Oral Explanation Success
Chapter 3: Selecting, Organizing, and Managing the Team
Chapter 4: Creating, Prioritizing, and Harmonizing Content
Chapter 5: Writing the Briefing Document
Chapter 6: Writing the Core Presentation
Chapter 7: Creating Slides and Visual Aids
Chapter 8: Creating, Managing, and Using Backup Slides
Chapter 9: Practicing the Core Presentation
Chapter 10: Preparing for Q&A
Chapter 11: Organizing Mock Oral Explanation Meetings
Chapter 12: Handling Game-Day Communications and Logistics
Chapter 13: Overcoming the Challenges of Virtual Oral Explanations
Chapter 14: A Final Word
List of Abbreviations
Overview of the Key EMA Advice Meetings and Their Goals
3D Communications, Publisher
About the Book
Available formats: print and e-book
RAPS has teamed up with 3D Communications to offer The CHMP Meeting Survival Manual, a step-by-step guide to help pharma and biotech teams succeed at CHMP meetings. The book is based on 3D Communications’ experience preparing more than 50 pharmaceutical and biotech companies to present at a range of high-stakes meetings with the European Medicines Agency (EMA). This book helps teams turn their complex evidence packages into a clear and persuasive narrative to present to European regulators.
The CHMP Meeting Survival Manual is an essential resource for busy regulatory professionals, offering quick overviews, figures, and tables to help teams navigate the CHMP process. It provides a clear structure for both new and experienced professionals to quickly understand key topics and efficiently communicate critical information to internal stakeholders. The book covers everything from the CHMP review process and timeline to practical tips for developing briefing documents, presentations, and slides tailored for EMA meetings. It also offers advice on message development, storytelling techniques, Q&A preparation, and virtual meetings. The step-by-step guidance ensures teams are well-prepared for every aspect of the CHMP meeting process, with actionable tools that can be immediately applied to daily work.
Whether you're new to CHMP meetings or looking to refine your approach, this manual is the ultimate guide to navigating the process with confidence and success.
Who will benefit from this book?
The CHMP Meeting Survival Manual is designed for anyone involved in preparing for and navigating the EMA approval process, offering clear, practical insights to ensure success at CHMP meetings.
Special Thanks to 3D Communications
3D Communications is donating all royalties from sales of this book to The RAPS Convergence Student Ambassador Program. This program empowers the next generation of regulatory professionals to attend RAPS Convergence, enhancing their regulatory education while providing important networking opportunities. By purchasing this book, you’re not only gaining valuable resources, but you’re also contributing to a meaningful cause.
Purchasing Options
This book can be purchased in the following formats:
- Digital e-book. Single purchase; accessible online via RAPS Library online reader and downloadable.
- Printed book.
This book can also be purchased as part of the following bundles:
- All Access Library (12-month digital subscription)
Published by RAPS © 2024. Paperback. 109 pages.
