US Regulation of Advertising and Promotion of Drugs

6.0 RAC Credits On-demand     Member: $399.00 Nonmember: $499.00


US Regulation of Advertising and Promotion of Drugs

This is an On-demand recording from June 2021 

Examine current guidelines and expectations for advertising and promotion of pharmaceuticals and biologics in the US in this online training event. Broken into two half-day sessions, this virtual event will cover the current requirements for advertising and promotion of healthcare products in the US, and how they impact the way you communication with healthcare professionals, consumers and managed care audiences. The program will feature industry leaders, regulatory experts and legal professionals who will share their expertise through presentations, discussions and case studies.

Pricing Amounts & Deadlines

16 March – 4 May 2021: Early $399 Member | $499 Nonmember

5 May – 23 June 2021: Regular $499 Member | $599 Nonmember

Objective

  • Examine the current structure and regulatory climate at FDA
  • Provide a strategic-level overview of the overall regulation of promotional materials
  • Review key topics in the advertising and promotion world, including Consistency with Labeling, Direct-to-Consumer (DTC) promotion, and Payor Communications
  • Understand the role of FDA and FTC

Who Should Attend?

  • Early to mid-level regulatory professionals involved in advertising and promotion of drugs for the US market, plus:
  • Regulatory consultants
  • Compliance specialists
  • Food and drug lawyers
  • Marketing representatives
  • Medical communications professionals
  • Medical affairs
  • Medical writing
  • Medical Science Liaisons (MSLs)
  • Clinical research professionals

Agenda

Day 1

  • Current FDA Environment for Advertising and Promotion
  • Strategic Overview of Drug/Biologic Advertising and Promotion Regulation
  • Consistency with Labeling – Analysis of Industry Implementation

Day 2

  • FTC Hot Topics & Law Enforcement: Trends in the Health Product Industry
  • Direct-to-Consumer (DTC) Pharmaceutical Advertising – New Developments
  • Payor Communications

Speakers

Glenn Byrd

Glenn Byrd, MBA, President, GByrd Ad-Promo Solutions, LLC

Glenn currently runs his own consulting company focused on providing expert advertising and promotion regulatory support to the biopharmaceutical industry. Glenn previously headed the AstraZeneca Oncology Promotional Regulatory Affairs team for over 11 years. He has held numerous regulatory leadership roles over his 29 year career in regulatory affairs. Glenn has served on the RAPS Board of Directors for the last 9 years and is currently President of the Board.

He also spent 10 years at the US FDA (6yrs in CDRH as a device reviewer and 4 yrs in CBER as head of the Advertising and Promotional Labeling Branch).

Glenn's experience includes roles in government, industry, consulting firms and Clinical Research Organizations (CROs). He received his MBA from Hood College and his BS in Aerospace and Ocean Engineering from Virginia Tech.


Catherine Gray

Catherine Gray, Acting Director, Office of Prescription Drug Promotion, Center for Drug Evaluation and Research, FDA - Invited

Speaker Information To Be Confirmed.






Carolyn Hann

Carolyn Hann, JD, Chief of Staff for Advertising Practices, FTC

Carolyn L. Hann is the Chief of Staff for Advertising Practices in the Federal Trade Commission's Bureau of Consumer Protection, Division of Advertising Practices in Washington, DC. During a recent FTC detail to the U.S. House of Representatives, she served as counsel to the House Energy & Commerce Committee, where she advised on consumer protection issues. She previously served as an attorney advisor to Commissioner J. Thomas Rosch and as a staff attorney in the Bureau of Consumer Protection's Division of Enforcement. Carolyn has led several FTC law enforcement actions involving complex health issues, such as CellMark, Tommie Copper, and GeneLink.

Prior to joining the FTC, Carolyn worked in private practice, specializing in advertising, marketing, and food and drug law. She received her J.D. from The University of Chicago Law School and her B.A. from Haverford College.


Dale Cooke

Dale Cooke, JD, MA, President, PhillyCooke Consulting

Dale Cooke is the president of PhillyCooke Consulting, which helps companies communicate about FDA-regulated products using 21st century tools, while remaining compliant with regulations written in the 1960s. Dale has worked with more than 50 pharmaceutical and medical device clients and more than 20 advertising agencies around the world. His insights have been featured in the Politico, The Pink Sheet, Stat News, Law360, and other publications. Dale is an active member of the Regulatory Affairs Professionals Society (RAPS), Drug Information Association (DIA), Food and Drug Law Institute (FDLI), the Alliance for a Stronger FDA, and the Google Health Advisory Board.

Dale is the author of Effective Review and Approval of Digital Promotional Tactics, which is now in its second edition in FDLI's Topics in Food and Drug Law series. He is regularly invited to speak at industry conferences on topics including FDA enforcement trends, best practices for review processes, global review practices, and life sciences use of social media. Previously, Dale served as the head of Regulatory for Digitas Health LifeBrands, which is part of the Publicis Healthcare Communications Group.

Dale earned his B.A. in Philosophy from Southern Methodist University, an M.A. in Philosophy from the University of Arizona, studied Epidemiology and Biostatistics at Drexel University's School of Public Health, received a graduate certificate in Healthcare Compliance from Seton Hall University's School of Law, and earned his JD at Drexel University's Kline School of Law.


Carla Brooks

Carla Brooks, Senior Director, RA Advertising & Promotion, Blueprint Medicines

Carla serves as the primary regulatory advertising and promotion reviewer at Blueprint Medicines Corporation. Prior to joining the team, she was a key leader of the Compliance Leadership team at United Therapeutics, and worked in the North America Compliance and the Promotional Regulatory Affairs departments at AstraZeneca. Carla's experiences have ranged from preclinical and clinical research and development to post-approval marketing and have allowed her to gain insight into the full spectrum of the biopharmaceutical product lifecycle. Carla received the Healthcare Compliance Certification from Seton Hall Law School and the Regulatory Affairs Certification (RAC) from RAPS. She has an MS in Biotechnology from Johns Hopkins University and a BS in Biology from Morgan State University in Baltimore, MD

Cancellation Policy

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 via our online cancellation form. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and the event title. Substitutions may be accepted with written approval from RAPS and must be submitted to raps@raps.org.

Proof of Attendance

RAPS will send an electronic letter or a certificate of attendance upon request.

Questions

Call RAPS Solutions Center at +1 301.770.2920, Ext 200