US Regulation of Advertising and Promotion for Drugs

6.0
RAC Credits
Thursday, 24 June 2021 (12:00 PM) - Friday, 25 June 2021 (4:00 PM) Eastern Time (US & Canada)

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 communicate 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

Objectives

  • 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

Micheline Awad

Micheline Awad, MBA, Director Regulatory Affairs, Advertising and Promotion, Neurocrine Biosciences, Inc.

Micheline Awad leads the Neurocrine Biosciences Promotional Review Committee (PRC) as well as represents Regulatory on the Medical Review Committee (MRC). She has 20 years of Biotechnology/Pharmaceutical industry experience including 3 years in Regulatory Affairs (RA) and 14 years in RA - Advertising & Promotion. She has been at Neurocrine Biosciences for approximately 5 years. Micheline’s Regulatory experience includes Biologic, Drug, and Device, and multiple product/indication launches. She received her M.B.A. from University of Southern California with a focus on Strategy and Marketing, and her B.S. in Biology specializing Biotechnology from George Mason University.


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


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 and teaches at UNC Wilmington in their undergraduate and graduate Clinical Research programs. Glenn has spent 30+ years in the Regulatory field; previously heading the AstraZeneca Oncology Promotional Regulatory Affairs team for over 11 years and has spent the last 21 years of his career focused on Advertising and Promotion. Glenn has served on the RAPS Board of Directors for the last 10 years and is currently Chairman of the Board.

He 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 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.


Richard L. Cleland

Richard L. Cleland, Assistant Director, Division of Advertising Practices, Federal Trade Commission

Mr. Cleland joined the Federal Trade Commission's Division of Advertising Practices in 1991. In 1996, Mr. Cleland was appointed Assistant to the Director of the Bureau of Consumer Protection and, in 1998, he was appointed Assistant Director of the Division of Service Industry Practices. He currently serves as Assistant Director of the Division of Advertising Practices. His primary area of expertise is the advertising and marketing of health-related products and services. He also supervises many of the Commission's health fraud law enforcement initiatives. Mr. Cleland supervised the FTC's review of the Endorsement and Testimonial Guides and the revision of the FTC's guidance on making effective disclosures on the Internet and other digital platforms (.com Disclosures). Mr. Cleland’s most recent work has focused on supervising the Commission's efforts to stop sellers of bogus products and services promoted to treat or prevent COVID-19.


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.


Jean-Ah Kang

Jean-Ah Kang, PharmD, Special Assistant to the Director, Office of Prescription Drug Promotion (OPDP), CDER, FDA

Jean-Ah has over 20 years of varied experience in prescription drug promotion. She currently focuses on policy/guidance development/communications initiatives for OPDP and has a special interest in social media/accelerated approval issues. Prior to this role, she worked in the private sector as a senior regulatory affairs consultant at Science Applications International Corporation (SAIC), where she advised pharmaceutical clients on advertising and promotion matters, trained multi-disciplinary review teams on related FDA regulations, and recommended best practices for regulatory compliance. Before joining SAIC, she served in FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC) in both team leader and oncology reviewer positions.

Jean-Ah began her career as an assistant professor at Shenandoah University after completing a drug information residency at the University of Pittsburgh Medical Center. She earned a Doctor of Pharmacy degree from the University of Maryland and graduated with a double major in Biochemistry and Music (Distinguished Majors Program) from the University of Virginia.


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