Overview

Primer: March 05, 2024 | Virtual

Conference: March 12-13, 2024

DIA’s Advertising and Promotion Regulatory Affairs Conference is in its 35th year! The conference explores the current state of compliance for marketing both biopharmaceuticals and medical devices. Join thought leaders from industry, legal, public affairs, and government for interactive and compelling discussions that will shape policy and define strategic priorities within the advertising and promotion regulatory space.

This conference is geared towards both early and late-career professionals with content that advances the understanding of current regulatory policies, details the latest strategies for professional development, and discusses the trends in advertising for medical products. You will have the opportunity to network with key thought leaders from the FDA, industry, and other regulatory agencies, while simultaneously discussing the challenges and opportunities of marketing pharmaceuticals and medical devices today.

Need Approval in Order to Attend?

Download and fill out our Justification Letter to demand to supervisor why this is a must-attend event.

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Participant Testimonials

It was a great event. The speakers and panels were very informative, relevant, and organizedwell. It was also a wonderful opportunity to network and meet new individuals who work in thesame/similar role at other companies. – James Chang – Astellas

This conference is a great opportunity to learn recent trends in our industry, and hear about exciting issues hot topics. It was so great to see everyone in person again as well and network. – Kavita Vazirani – Opus Regulatory, Inc.

All levels of regulatory A&P expertise can benefit from it. Besides educational presentations, the face-to-face social networking aspect of this event was exceptionally good. Breaks after every session helped us refreshed and focused. – Iram Quraishi – Takeda

Keynote Address!

March 12 | 8:45 - 9:30 AM

Session 1: Keynote Address: The Future of Prescription Drug Promotion and Digital Marketing: Insights from an Expert Convening

The Keynote has Been Released! Victoria Gemme, MBA, MS, Policy Research Associate, Duke-Margolis Center For Health Policy

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Welcome Video

Who should attend?

Meeting Designed For

Join professionals from every corner of the vast realm of Advertising and Promotion Regulatory Affairs:
- Regulatory Affairs
- Marketing
- Communications
- Compliance
- Medical Information and Affairs
- Legal
- Patient Engagement

Learning objectives

At the completion of this conference, the participant should be able to:
- Identify current and future digital marketing tools and their impact on patient, HCP and consumer perceptions and behaviors
- Gain insights from the FDA on recent compliance actions, advertising and labeling concerns, and the activities involved in regulating medical product promotion
- Describe the Better Business Bureau’s National Programs and the National Advertising Division’s role in pharma promotion
- Determine when to act and submit a cease-and-desist letter to the company or complaint to regulatory agencies
- Identify how early development decisions impact advertising and promotion
- Identify viable options for incorporating diverse patient perspectives into product advertising
- Describe the SASS standard and the importance of rigorous CFL assessment
- Describe how to assess CFL claims in the context of consumer-facing materials based on the FDA Guidance
- Analyze international regulatory ad promo enforcement
- Describe the regulatory basis for scientific exchange
- Determine how AI can be leveraged as a compliance tool

Short Course or Primer

To keep you at the forefront.

Mar 05, 2024

Drug and Biologic Ad Promo Primer:

Learn more

Mar 05, 2024

Drug and Biologic Ad Promo Primer:

Learn more

Program Committee

Alyson Andrikanich, PharmD Senior Director, Advertising and Promotion, Regulatory Affairs Americas
Bayer Pharmaceuticals, United States
Lynn Bowen, PhD Vice President, Regulatory Affairs Advertising Promotion & Labeling
Alkermes, Inc., United States
Bob Dean, MBA Head of Global Labeling Strategy & Ad/Promo
EMD Serono, United States
Anthony Genovese, PharmD Group Leader, Regulatory Advertising and Promotion
Johnson and Johnson, United States
Nicol Lorraine George, PharmD, RPh Vice President, Promotional Review & Labeling Services
ProPharma Group, United States
Catherine Gray, PharmD Director, Office of Prescription Drug Promotion, OMP, CDER
FDA, United States
Joanne Hawana, JD, MS Member
Mintz, Levin, Cohn, Ferris, Glovsky & Popeo P.C., United States
Georgina Lee, PharmD Executive Director, Regulatory Advertising and Promotion
Sage Therapeutics, United States
Amy Muhlberg, PhD Deputy Director, OPDP’s Division of Promotion Policy, Research and Operations
FDA, United States
Moulakshi Roychowdhury, JD, PharmD Global Head, Regulatory Affairs, Advertising & Promotion, Allergan Aesthetics
AbbVie, United States
Dale Cooke, JD, MA President
PhillyCooke Consulting , United States
Mark Gaydos Global Head, Advertising & Promotion, Global Regulatory Affairs
Sanofi, United States
Micheline Awad, MBA Sr. Director, Regulatory Advertising, Promotion, and Labeling
Day One Biopharmaceuticals, United States
Representative Invited DIA, United States