Every important communication begins with understanding what your audience needs and wants to hear — and setting a communications goal that focuses on the key concepts that you want and need regulators to grasp. The important word here is “key.” If you communicate everything you know, your audience simply won’t retain anything.
The challenge: how do you distill a massive amount of data and science into clear, concise, and credible messages that are relevant and memorable to regulatory authorities?
Learn what it takes to effectively develop key messages and communicate them with confidence in any regulatory engagement — large or small, phone calls or meetings, written on paper or delivered virtually (or delivered on camera). By leveraging a proven process and practical tools — and receiving expert, hands on coaching — you can guide your team to create messaging that resonates, has impact, and helps you achieve your goals.
Registration Fees & Deadlines
Present–16 September 2024: Member $150 | Nonmember $175
16 September 2024 – 16 October 2024: Member $175 | Nonmember $200
Learning Objectives
- Develop key messages that meet your communication objectives
- Identify the most important facts that support these key messages
- Create stories that will engage your audience and visually support your key messages
Who Should Attend?
Whether you are responsible for a single regulatory application, leading a team, or managing a broader regulatory portfolio, this workshop will provide you with practical tools to increase your success handling regulators’ questions.
Speakers
Virginia Cox
Communications Lead, 3D Communications
Virginia 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 US Food and Drug Administration (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. Virginia supports numerous charities for cancer research, ending childhood hunger, rescuing animals, and preserving the environment. As a mother of two competitive athletes, she spends most of her free time on the ski slopes or the side of a soccer field. A perfect day includes skiing with her family, hiking, and cooking with her husband.
Bert Regeer
Science Lead, 3D Communications
As a medical doctor with three decades of experience in the pharmaceutical industry, Bert is an invaluable resource for the 3D Communications team and provides in-depth scientific knowledge. He is known for his sharp strategic mind and thorough understanding of data. Bert approaches projects with an almost infectious positive attitude and commitment. His style is direct and no fuss. Nothing escapes his attention, and he does not hesitate to challenge the team by addressing the hard issues. Bert has more than 30 years’ experience in clinical development and regulatory submission strategy while working at 3D and previously at some of the largest pharmaceutical companies in the world. His expertise in clinical program design, development, and implementation helps clients prepare FDA and EMA applications, as well as regulatory interactions that support product development. In his role as a senior medical executive at Roche and Bristol Myers Squibb, he was instrumental in designing clinical trials, obtaining approval for new medications, and increasing market value for those companies. His expertise spans both small molecules and biologics in the areas of oncology, cardiology, endocrinology, immunology, infectious diseases, neurology, and supportive care. He holds an MD from Leiden University, Netherlands. A family man above all else, Bert loves to spend time with his five kids, who reside both in Europe and the US. He enjoys being in nature by hiking, playing outdoor sports, and sailing.
Cancellations and Refunds
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email
RAPS@raps.org