RAPS Workshop: Taking Q&A with Regulators to the Next Level

Answering questions —written or verbal— from FDA and other health authorities is a necessary step to get healthcare products approved. The Question and Answer (Q&A) portion of any regulatory meeting is a make-or-break opportunity to convey your messages, relieve doubts, and move your product forward. 

Learn what it takes to be prepared for the different types of questions and the different scenarios you and your team may face. Through this straightforward strategy and process you can ensure your team has effective and timely responses to regulatory questions and remove barriers to approval. 

Registration Fees & Deadlines

Learning Objectives

• Anticipate and prioritize questions.
• Plan for different scenarios and strategies for responding.
• Prepare answers and bridge to messages

Audience Learning Level

Advanced: Content is designed for individuals who are well-versed in most, if not all, concepts associated with the topic(s). Activities place a high concentration on analysis and application of concepts or demonstration of competencies through exercises such as case studies, scenario building, and group projects. A high level of participation is expected from each attendee.

Speakers

Amy Tezel, PhD
Scientific Lead, 3D Communications

Amy leverages a powerful combination of scientific, regulatory, and communications expertise to help clients achieve success in their highest stakes interactions. Amy works with clients to turn their data into compelling messages and presentations that resonate with regulatory, medical, and investor audiences. She has demonstrated success with clinical and regulatory submission strategy and writing, FDA and Advisory Committee meetings, developing and executing global regulatory strategies and scientific storytelling. Amy has nearly 20 years of experience in scientific communication and global regulatory affairs, holding regulatory leadership positions in a wide range of therapeutic areas at Allergan, Alcon, and BVI Medical. Amy received a bachelor’s degree in chemical engineering from the University of Washington and a PhD in chemical engineering from the University of California at Santa Barbara. Amy enjoys traveling with her husband, reading, running, and hiking, and is an enthusiastic soccer mom for her three young daughters. She also serves on the board of her local arboretum. 

Catherine Leonard, MA, RAC
Communications Lead, 3D Communications

Catherine is an experienced communications professional who has prepared companies across a wide range of therapeutic areas for more than 60 FDA Advisory Committee meetings and other US and European regulatory interactions. She combines her background as an academic writer, researcher, and lecturer with her understanding of science to develop clear, concise, and relevant messages that align across deliverables – ensuring an effective communication strategy for every interaction. Cat synthesizes complex data and information and translates them into simple concepts — building messages that reach and resonate with audiences and stakeholders. Whether working with individuals to script presentations or in group settings to draft messages, she is inclusive of client desires and needs while keeping the process moving forward. Cat is results-oriented and keeps clients working toward their communication and business goals. Before coming to 3D, Cat taught classes at the university, high school, and intermediate levels. Cat earned a bachelor’s degrees in history, political science, and nutrition from Pennsylvania State University, and a master’s degree in history from the University at Albany, where she also completed doctoral coursework in early American history. She holds Regulatory Affairs Certification (RAC US) from the Regulatory Affairs Professionals Society. Cat is an avid supporter of Penn State’s Four Diamonds Fund, and Big Brothers Big Sisters of America. In her spare time, she runs long-distance road races, coaches youth track programs, and enters culinary competitions. 

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