After years of development, it’s time to justify that an application has a positive benefit−risk and merits approval in the EU. Even for companies expert at handling US Food and Drug Administration (FDA) interactions, Committee for Medicinal Products for Human Use (CHMP) meetings can pose a challenge. They have unique characteristics that may make it even more difficult for company teams to overcome objections that stand in the way of marketing authorization. Join 3D Communications in a free webinar where the featured speaker will discuss what these characteristics are and provide practical process and tools to ensure teams are prepared to:
- Define the communications strategy necessary to achieve success
- Determine the deliverables to support a successful meeting
- Construct appropriate timelines
- Choose the appropriate team members, including external experts
Speaker
Kell Cannon, Scientific Lead, 3D Communications
Kell Cannon leverages 20 years of leadership experience at some of the world’s largest pharmaceutical companies along with over a decade of healthcare consulting experience to help clients achieve regulatory success and communicate product value. He has been instrumental in developing 3D Communications’ processes, tools and training which help clients prepare for regulatory submissions, key regulatory meetings at the FDA and European Medicines Agency (EMA) and important meetings with payers.
Kell collaborates with clients to systematically identify the strengths and weaknesses in their data, consider the realities of their environment and develop compelling messages that help companies differentiate their products. His knowledge and broad experience in regulatory affairs, science, marketing and value communications provide the unique holistic approach that is essential in today’s competitive market. Kell has held US and international leadership positions at Roche, Novartis, Ciba and Merck in clinical development and trial strategy, branding and positioning, advocacy development, commercialization and payer strategy. Kell has an MBA and a Bachelor of Science in Microbiology from Penn State University.
Message PresenterWho Should Attend?
This webinar will be useful to anyone preparing for a CHMP meeting, including Oral Explanation (OE), Scientific Advisory Group (SAG), ad hoc Expert Group or Pharmacovigilance Risk Assessment Committee (PRAC). The information can help them set realistic timelines, choose the best presenters and team members, plan and conduct effective mock meetings, utilize-technologies to improve the preparation and maximize the chance for a majority vote.
This includes team members from research, development, regulatory affairs, statistics and communications including but not limited to:
- Chief Medical Officer
- VP, Clinical Development
- Director, Clinical Development Lead
- VP, Regulatory Affairs
- Director, Regulatory Affairs
What You Will Learn
Participants will learn about:
- Characteristics of CHMP meetings
- Practical processes and tools to:
-
- Define the communications strategy necessary to achieve success
- Determine the deliverables to support a successful meeting
- Construct appropriate timelines
- Choose the appropriate team members, including external experts
Xtalks Partner
3D Communications
3D Communications is the global leader in preparing Pharmaceutical and Medical Device Companies for FDA Advisory Committees and EMA – CHMP /SAG/Oral Explanations. Our expertise and experience is the foundation of our success. 3D’s team is comprised of 65 full time colleagues — who specialize in all aspects of preparing our clients for the best possible outcome at these high-stakes regulatory meetings. Following our ACT process ensures that we “vet” all possible scenarios – applying knowledge gained from more than 300 advisory committee meetings. We support our team and process with state-of-the-art technology to ensure constant collaboration and accountability. Our clients typically engage us before they file their applications, through regulatory approval and product launch.
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