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Tuesday, June 22 • 9:30am - 12:30pm
025A: #025A: Optimizing Your Interaction With EU Regulatory Authorities: How to Prepare and Perform

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Component Type: Tutorial
CE: ACPE 2.75 Application UAN: 0286-0000-21-509-L04-P; CME 2.75; IACET 2.75; RN 2.75

Preregistration required and is an additional fee. Already registered? Log in to DIA's My Account>My Events.

The possibilities to meet and engage with EU regulators to discuss/explain your clinical development plans are few. A successful outcome of such meetings will often be critical for your decisions and could in the end be decisive for approval of your product. Having mapped out a plan for your regulatory interactions throughout product development and having your team prepared to present in its most persuasive manner is critical for success. Being well-prepared and performing professional is key to success. This include demonstrating intimate knowledge of your 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 your support. 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 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 you through the key steps in preparing as well as the “do’s and don’ts” when presenting and engaging with regulators. We will discuss how best to present your key massages and supporting slides and manuscript. This short course will include anonymized examples from real or imagined meetings and enable the participants to better understand the process and its challenges as well as how best to cope with these. Need approval in order to attend? Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.
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Who should attend?

This short course is designed for members involved in: Regulatory professionals independent on company size who are planning to are are actively engaged with EU regulatory authorities in particular during marketing authorization review.

Learning Objectives

Summarize a high-level understanding of the EU regulatory system; Define a basic knowledge of the EU centralized procedure; Describe how best to prepare your team for an EU regulatory agency meeting; Recognize effective communication; Define an oral explanation, oral hearing, regulatory meetings, communication, and authority interaction.


Instructors
avatar for John Ellis

John Ellis

Communications Coach, PharmApprove, United States
John Ellis has been communications coach at PharmApprove since 2008. He has coached upwards of thirty teams as they have prepared for FDA advisory committee meetings, as well as OE's and SAG's in Europe. In addition, he creates and delivers workshops on a range of communications skills... Read More →
avatar for Steffen Thirstrup

Steffen Thirstrup

Director, NDA Regulatory Advisory Board, NDA Advisory Services Ltd, United Kingdom
Steffen Thirstrup is a medical doctor and board certified specialist in clinical pharmacology and therapeutics. He holds a PhD in pharmacology and has a long background in clinical internal medicine. He is an adjunct professor in pharmacotherapy at the Faculty of Health Sciences... Read More →

Tuesday June 22, 2021 9:30am - 12:30pm EDT
TBD Virtual Event Horsham, PA 19044
  19: Short Courses, Tutorial |   09: Regulatory, Tutorial
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial