Book Review: The CHMP Meeting Survival Manual –
A Step-by-Step Guide to Succeeding at Regulatory Meetings for Marketing Authorization
Review by Meredith Brown-Tuttle, RAC
"The CHMP Meeting Survival Manual" is a step-by-step guide to help pharma and biotech teams succeed at CHMP meetings. The Survival Manual 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 EMA. As with 3D’s EMA services, this book helps teams turn their complex evidence packages into a clear and persuasive narrative to present to European regulators.
Regulatory is the conduit for communication between global regulatory agencies and internal stakeholders; therefore, Regulatory’s ability to rapidly understand the requirements, address the requirements with data/commit to providing the data and communication this internally and externally can make or break a company. 3D Communications has produced yet another book that I am going to always keep on my desktop. Why? In Regulatory, especially in small companies, you are doing many things, often at one time. You can remember only so much, that’s why you need summaries available to quickly orient or re-orient you on submission requirements and successful strategies. Often, I am looking for a quick overview, with lots of figures to introduce me to a new topic quickly or bring me back up to speed. After I’ve been primed on the overview of the topic, I am ready to dig in deeper in particular areas of interest. I then use this overview to orient C-level personnel, other regulatory department teams members, or development teams on the issues, requirements, format, timeline and make recommendations. The problem is, getting that overview in a succinct manner that provides a balance of depth and breadth on a topic can be a challenge. 3D Communication books always do just that, takes what can be an overwhelming topic for those not familiar with a topic, this time EMA meetings, and makes the process easy to understand, accessible and includes easy to understand figures and comprehensive tables.
This new book, The CHMP Meeting Survival Manual, is very useful CHMP meeting primer for new and old regulatory professionals alike for several reasons:
Provides a summary of 5 key EMA meetings that can be requested.
Provides an overview of the CHMP review process and timeline, explaining the critical milestones and activities that happen before and during each milestone. This helps you understand the standard review schedule and key decision points essential for regulatory professionals to effectively plan and prepare themselves and the team.
The book offers specific, practical tips for developing effective briefing documents, presentations, slides, and backup materials tailored for EMA review and meetings. Following these best practices can help ensure regulatory processes are optimized for the EMA meetings.
There are detailed recommendations on message development, storytelling techniques, and slide design optimized for EMA. I found this helpful for enhancing the clarity and persuasiveness of the presentation.
Tips for Q&A preparation, mock meeting rehearsals, and virtual meeting success to equip regulatory professionals with the skills needed to perform well at CHMP meetings.
Strategies are provided for selecting, preparing, and managing a meeting team. Especially helpful is the guidance on team roles, responsibilities, and dynamics helps regulatory professionals assemble the most effective group.
Invaluable insider knowledge into the workings of the EMA and dynamics of CHMP meetings is provided.
The step-by-step guide is incredibly thorough and detailed – it leaves no stone unturned in preparing teams for every aspect of CHMP meetings in a simple and easy to read format. Overall, the regulatory-specific focus and practical nature of the advice can enhance regulatory professionals' knowledge, strategy, skills, and confidence for engaging in the EMA approval process and interacting with the CHMP. Such comprehensive guidance is priceless.
The tools and lessons given in this book can be immediately applied to your job especially planning the long-term timelines for CHMP meetings. Additionally, the beauty of the colors and illustrations in this book really helps deepen reader comprehension of the material presented.
Meredith Brown-Tuttle, RAC is the chair of the RAPS Publication Task Force. She is a consultant for Regulatorium.com, an instructor for the UC-Santa Cruz Regulatory Certificate program, and author of “IND Submissions: A Primer” and “Regulatory Intelligence 101.” She can be reached at email@example.com.