Every drug development program has problems. Big ones, little ones. You will work through them one way or another. But the most challenging problems are those which you cannot solve yourself, those which only work if regulatory authorities such as the FDA agree with your ideas.
It will happen to you. And when it does happen, there will be one chance to get it right.
One chance to provide your detailed, scientific arguments to the regulator. One chance to sway them to your point of view. Success means the development program will continue on down the path of your choice. Failure leads to delays, cost blow-outs, even cancellation of the project.
Don't waste this chance. Purchase this guide.
In this book we:
- 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 your 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.
To achieve this the book covers a number of areas:
- 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 for your current situation? Then take a look today.
