How to Effectively Communicate with FDA and EMA Regulators – In a Virtual Meeting Environment

Life Sciences, Pharmaceutical Regulation, Pharmaceutical, Drug Discovery & Development, Biosimilars,
  • Thursday, April 09, 2020

3D Communications has spent two decades preparing companies for meetings with regulators – including FDA pre-submission and Advisory Committee meetings, and CHMP Oral Explanations. During this time, 3D has developed its “Top 10 Rules” to help make the journey smoother for clients and help them effectively hit their target.

Now, with company regulatory teams all working remotely from different locations, and FDA and EMA telling sponsors and applicants to prepare for virtual meetings – companies face new challenges.

In this webinar, 3D experts – including former FDA team members – will provide relevant case studies and showcase processes and technology that address these challenges.

They will also identify some of the common mistakes that sponsors and applicants make in their communications with regulators, and discuss ways they can effectively prepare for, and execute in, a virtual environment.

What You Will Learn

  • How to ensure your team members establish the right relationship with regulators, have a clear “win” for the interaction, and understand their audience and regulatory precedent.
  • How to run efficient and effective remote rehearsals with your company’s team members as they prepare for interactions with regulatory authorities.
  • How to execute during the virtual meeting itself, including:
    • Making sure your speakers can get immediate access to appropriate data and slides as needed;
    • Conducting efficient Q&A with responders in numerous locations;
    • Having private conversations with internal team members during the meeting; and
    • Managing technology issues in a virtual meeting environment.

3D Communications is preparing companies for virtual regulatory meetings and has already been conducting full-scale virtual rehearsals for company teams that are all participating from different remote locations. 3D offers practical, proven tactics to help companies communicate effectively with regulators so that meetings are productive and successful.

Speakers

http://Virginia%20Cox,%20JD%20,3D%20Communications

Virginia Cox, JD - Senior Consultant and Lead, 3D Communications

Virginia Cox has spent more than 25 years in healthcare communications, including at the highest levels of government. She brings a unique blend of strategic communications skills, health policy background, and firsthand FDA regulatory experience to all her clients.

Virginia helps clients embrace any communications challenge – no matter how complex and complicated – and turn it into an opportunity to deliver a compelling story. Her years of experience at the FDA and US Department of Health and Human Services (DHHS), combined with her background in law, enable her to approach any healthcare communications challenge with a critical eye and sound advice. Since joining 3D Communications, she has helped clients prepare for more than 50 FDA Advisory Panel meetings and submissions, as well as numerous CHMP meetings.

Prior to rejoining 3D Communications, Virginia was the highest-ranking communications officer at the US FDA. As associate commissioner for the Office of External Affairs, she provided strategic leadership and communications oversight to a wide range of agency activities. She also served as a special assistant to the secretary of the US DHHS, and as the FDA commissioner’s director of outreach and strategic initiatives. Before working at the FDA, Virginia worked at 3D Communications and the Consumer Healthcare Products Association, where she was senior vice president for communications and strategic initiatives. She received an undergraduate degree from the University of California, Los Angeles and a law degree from Georgetown Law, and is a member of the Maryland Bar Association.

Message Presenter
http://Adam%20George,%203D%20Communications

Adam George, PharmD - Senior Consultant and Lead, 3D Communications

Adam George is a seasoned regulatory affairs professional with broad expertise that leverages his prior experience as an FDA Office of New Drugs clinical reviewer to bring a dynamic approach to clients. He specializes in interactions with current and former US regulatory authorities; expedited development programs for rare, serious, and life-threatening diseases; 505(b)(2) new drug applications; and biosimilars.

Adam is known for his creative, analytical, and detail-focused approach to scientific and regulatory communications. He works closely with clients and key opinion leaders to create cohesive and convincing scientific messages supported by credible data presentations.

Before joining 3D Communications, Adam was a regulatory affairs therapeutic area head for oncology, respiratory drugs and biologics at Teva Pharmaceuticals. Prior to joining Teva, he spent more than six years at the FDA as a clinical reviewer in the Division of Hematology Products (DHP), Office of Hematology Oncology Products, and as a senior regulatory reviewer in the Office of Prescription Drug Promotion (OPDP).

As a clinical reviewer in DHP, he was responsible for the clinical review of NDAs, BLAs, and INDs for drugs to treat hematologic malignancies. He has reviewed and recommended products to be discussed at the Oncologic Drugs Advisory Committee, as well as reviewed and recommended products for fast-track designation, priority review, and breakthrough therapy designation. At OPDP, he was responsible for the review of promotional materials for hematology-oncology products and anti-infective agents. He holds a PharmD from Temple University.

Message Presenter
http://Jim%20DiBiasi,%203D%20Communications

Jim DiBiasi, 3D Founding Partner & Communications Lead, 3D Communications

Jim DiBiasi has provided strategic and tactical communications counseling and coaching to top executives, scientists, and doctors in the pharmaceutical, biotech, and medical device industries. With experience guiding more than 100 companies through high-stakes regulatory interactions, Jim is known for his ability to lead diverse teams and help them achieve their goals at decisive communications opportunities.

Jim’s unique approach focuses on both the individual client and the client’s audience. He coaches clients on the need to get into the audience’s head to effectively communicate, so speakers can use audience insights to inform how they develop and deliver clear, engaging, and impactful messages. He also uses 3D Communications’ proprietary process, practical tools, and purpose-built technology to help clients analyze their audience and prepare for challenging communications in more effective ways. Jim is dedicated to bringing out the best in each client – addressing challenges, seizing opportunities, and maximizing their unique talents and skills in every communication.

Jim has always been an entrepreneur who enjoys solving complex problems with creative solutions. With a strong background in business, finance, and accounting, he began his career with Ernst & Young in Philadelphia. He became a CPA, and initially was focused on finance in the independent energy sector, where he was involved in more than a billion dollars in non-recourse debt financing. Moving beyond finance and into operations and communications, he has been responsible for marketing, public relations, contract management, and legislative lobbying – and served as a media spokesperson for a Fortune 500 company. Before 3D, Jim owned a company that developed, financed, oversaw construction, and operated independently owned power plants. He earned an undergraduate degree in accounting from Villanova University.

Message Presenter

Who Should Attend?

  • Senior level professionals working within Regulatory Affairs and Clinical Operations for pharma, medical device and biologics companies
  • Anyone preparing for interactions and regulatory meetings with FDA

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

Xtalks Partner

3D Communications

3D Communications is the global leader in preparing Pharmaceutical, Biotech, and Medical Device companies for FDA and EMA regulatory meetings, including FDA Advisory Committee meetings and CHMP/SAG/Oral Explanations. We also specialize in preparing teams for launch and value communications, including market access negotiations. 3D’s team of 65 full-time colleagues specializes in all aspects of both virtual and live meeting preparation. Our team’s experience from hundreds of regulatory and commercial projects, our proven 3D ACT® process, and our state-of-the-art technology ensure our clients are prepared for the best possible outcome in the most challenging situations.

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