No clinical development program is perfect. Communicating a positive benefit-risk is essential to approval of a regulatory submission. In this free webinar, hear about a practical comprehensive step-by-step method to highlight your product’s strength and overcome its barriers.
- Proactively identify and address gaps, limitations and concerns;
- Align your team’s goals and messaging across the submission document; and
- Enhance your interactions with regulatory agencies
Kell Cannon, Founding Partner & Scientific Lead, 3D Communications
Kell Cannon, leverages 20 years of leadership at some of the world’s largest pharmaceutical companies along with 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 US Food and Drug Administration (FDA), 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.
Who Should Attend?
This webinar will be useful to anyone working in the pharmaceutical, biologics and medical device industries who is contributing to interpreting and communicating the clinical data within the integrated analyses and benefit-risk overview within your submission. This includes team members from research, development, regulatory affairs, commercial or marketing 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 gain insights into:
- Best practices for communicating a positive benefit-risk that can support approval of a regulatory submission
- Barriers to regulatory success
- Strategies to maximize credibility when interpreting data
- Aligning goals and messaging across the submission document
- Maximizing interactions with regulatory agencies
3D Communications 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.