Optimizing Your Interaction with EU Regulatory Authorities: How to Prepare and Perform
There are few possibilities to meet and engage with EU regulators to discuss/explain your clinical development plans. A successful outcome of such meetings will often be critical for decisions and could, in the end, be decisive for approval of a product. Having mapped out a plan for regulatory interactions throughout product development and having the team prepared to present in its most persuasive manner is critical for success. Being well-prepared and performing professional is key to success. This includes demonstrating intimate knowledge of data to meet regulator’s concern as well as being able to present this in a crisp and clear manner. To get to this stage takes meticulous preparation of key messages, slides, and the actual speech and may additionally include training key opinion leaders and/or patient representatives to speak or respond to questions in support of the product. Finally, preparing a head of questions and being able to respond clear and unequivocally to these are equally important to increase chances of success. This on-demand short course focuses on how best to plan, manage, prepare, and execute successfully at EU high-stakes meetings. A former CHMP member and a communication specialist will walk through the key steps in preparing as well as the “do’s and don’ts” when presenting and engaging with regulators. This course will review how best to present key massages and supporting slides and manuscript. Anonymized examples from real or imagined meetings will be reviewed to enable the participants to better understand the process and its challenges as well as how best to cope with these.
This on-demand short course takes 2.75 hours to complete. Learners have access to the course for one year from the date of purchase.
- EU Procedures
- Preparing for an Oral Explanation (OE)
- Performing Well at High-Stakes Meetings
- Choosing your Team
- Preparing your Presentation and Q&A
- Rehearsing and Use of Mock Panels
Who should attend?
This short course is designed for regulatory professionals who are planning to or are actively engaged with EU regulatory authorities in particular during marketing authorization review including:
- Regulatory Affairs professionals
- Drug Development professionals
- Project managers
- Professionals involved in clinical trials
At the conclusion of this short course, participants should be able to:
- Identify the EU regulatory system
- Recognize the EU centralized procedure
- Determine the proper preparation for an EU regulatory agency meeting
- Define an oral explanation, oral hearing, regulatory meetings, communication, and authority interactions