The advertising and promotion of prescription drugs and biologics in the United States is governed by a complex and evolving regulatory framework that requires careful coordination between regulatory, legal, compliance, medical, and marketing professionals. This workshop, developed in collaboration between DIA and RAPS, provides participants with a comprehensive understanding of the current regulatory and legal environment, enforcement trends, and promotional tactics that comply with FDA requirements. The program incorporates real-world scenarios and practical examples to ensure attendees leave with the tools needed to navigate this high-stakes space.
Through presentations, group discussions, and interactive case studies, participants will explore FDA’s requirements (OPDP/APLB), promotional review processes, and common challenges such as social media, digital communications, disease awareness campaigns, and booths at medical conventions. Attendees will also learn about the roles and responsibilities of promotional review committee members, enforcement mechanisms (including warning and untitled letters), and other applicable regulations such as the FTC Act and Lanham Act. Whether new to the field or seeking a structured refresher, this workshop is designed to equip professionals with the knowledge needed to confidently support compliant promotional efforts.
Registration Fees & Deadlines
DIA and RAPS members: Early Bird $580 | Regular $680
Nonmember: Early Bird $680 | Regular $800
Government/non-profit/academia: Early Bird $390 | Regular $455
Learning Objectives
Participants will be able to:
- Discuss the current regulatory, legal, and compliance environment for prescription drug and biologic promotion in the US.
- Understand FDA (OPDP/APLB) requirements.
- Describe the roles and responsibilities of Promotional Review Committee members and the operational review process.
- Recognize key enforcement mechanisms including FDA letters, FTC actions, and DOJ settlements.
- Apply best practices to common challenges including disease awareness campaigns, booths at conventions, and social media promotion.
Who Should Attend?
- Regulatory Affairs Professionals
- Regulatory Strategy
- Legal and Compliance
- Marketing and Communications Professionals
- Promotional Review Committee Members
- Consultants supporting promotional activities
- Early-career professionals or students interested in Ad Promo regulations
Audience Learning Level
Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Agenda Highlights
*Full agenda coming soon—stay tuned!
Thursday, November 20
High-Level Overview of Ad Promo
Session Chair: Micheline Awad, MBA
Senior Director, Regulatory Advertising, Promotion, and Labeling, Day One, Biopharmaceuticals
Legal Overview
Session Chair: Heather Banuelos, JD
Counsel, King & Spalding LLP
Ad Promo and Drug Promotion Basics
Session Co-Chairs:
Micheline Awad, MBA, Senior Director, Regulatory Advertising, Promotion, and Labeling, Day One, Biopharmaceuticals
Kimberly Belsky, MS, Regulatory Policy & Intell and AdPromo, Regulatory Affairs, Independent Consultant
OPDP 101
Session Chair: Twyla Mosey, PharmD
Division Director, FDA
Friday, November 21
Introduction to Day Two and Enforcement and Compliance Actions
Session Chair: Twyla Mosey, PharmD
Division Director, FDA
Hot Topics
Session Co-Chairs:
Micheline Awad, MBA, Day One, Biopharmaceuticals
Heather Banuelos, JD, King & Spalding LLP
Kimberly Belsky, MS, Independent Consultant
Enforcement Actions and Trends Case Examples
Presenter: Kimberly Belsky, MS
Regulatory Policy & Intell and AdPromo, Regulatory Affairs, Independent Consultant
Closing Remarks
Speakers
Micheline Awad, MBA
Senior Director, Regulatory Advertising, Promotion, and Labeling, Day One, Biopharmaceuticals
Kimberly Belsky, MS
Regulatory Policy & Intell and AdPromo, Regulatory Affairs, Independent Consultant
Twyla Mosey, PharmD
Division Director, CDER, OPDP, FDA
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
support@raps.org.