Scientific Advice Meetings: A Guide to Successful Interactions with FDA, EMA and Beyond - E-book - ePub

Ensure that your advice meetings lead to a positive outcome. Every drug development program has problems. But sometimes more difficult challenges arise. Ones which require discussion with regulatory authorities such as FDA to solve. There is one chance to get this right. One chance to provide your detailed, scientific arguments to the authority and sway them to your point of view. Success means the development program will continue on down the path of your choice.
Failure can lead to cost overruns, delays or even cancellation of the project. Don't waste this chance. Purchase this guide. This book will: Provide a step-by-step guide: With in-depth discussion of each part of the process, from initial idea generation through to post-meeting stakeholder management, you can ensure that nothing is missed. Help determine your ideal strategy: Via a comprehensive guide to developing a formalized statement of what you want to achieve, perfect for keeping the team on track and getting management buy-in.
Encourage persuasive writing: Information on structuring a briefing book, developing your chain of logic, and the art of writing ensures that you will maximize your chances of success. Help new and experienced professionals: Providing baseline knowledge for those new to the field as well as tips and tricks for late-career experts.  How does it manage this? We've included the following chapters: Chapters 1 & 2 provide baseline knowledge for people entering the field, including the role that regulatory authorities play, their expectations, and information on the meeting types offered by FDA, EMA, PMDA and NMPA.
Chapter 3 discusses best practice for creating a strategy and formalizing it into a document for team discussions and stakeholder management. Chapters 4 and 5 describes the requirements for the initial application, then the process of creating a persuasive and comprehensive briefing book. Chapters 6 and 7 cover preparation for the meeting - the initial practice rounds, dealing with challenge sessions, interpreting the preliminary feedback, then finalizing your strategy and company presentation.
Chapters 8 and 9 describe best practices for the meeting itself and the activities which need to occur after it has been held. Finally several appendices discuss writing skills for persuasive documents, review best practice, and problem solving skills.  Sounds helpful? Then take a look today.