Advertising and Promotion Regulatory Affairs Conference

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Overview

March 4: Primer
March 8-9: Conference

DIA is offering a virtual conferencefor the Advertising and Promotion Regulatory Affairs Conference that allows you to view all the session recordings from the comfort of your own home/office. Can't make all the sessions live? You will receive access to the On Demand library with your registration for 2 months post-conference.

DIA’s Advertising and Promotion Regulatory Affairs 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 effective patient engagement, 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 practitioners, while simultaneously discussing the challenges and opportunities of marketing pharmaceuticals and medical devices today.

On-Demand Webinar

Avoid Unwanted Attention to Your Press Releases

Wednesday, February 2, 2022 | 12:00 – 1:00PM ET
This pre-event promotional webinar will address some of the issues companies are facing when developing press releases and why these communications can be challenging. The webinar will cover the historical regulation of Press Releases by the FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC)/Office of Prescription Drug Promotion (OPDP), draw key concepts from previous FDA enforcement and illustrate principles to avoid FDA action. The webinar will also frame the key legal and regulatory considerations companies should be aware of when issuing Press Releases.

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Continuing Education

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Exhibits

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Highlights & Features

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Short Course or Primer

To keep you at the forefront.

Mar 04, 2022

Drug and Biologic Ad Promo Primer
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Who should attend?

Professionals involved in:

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:

Discuss current regulatory/legal/compliance environment pertaining to the advertising and promotion of prescription drugs, vaccines, and biologics
Discuss the latest FDA policies, guidance’s, and how they apply on a practical basis to day to day oversight of advertising and promotional materials for biopharmaceuticals and medical products
Apply lessons from recent compliance actions to current advertising and promotion review work
Recognize material differences for disease awareness in unbranded and branded communications
Describe the regulatory framework for evaluating traditional and online DTC TV ads
Describe the role and objectives of the FDA on advertising and promotion issues
Apply key learnings and best practices shared by the panelists with their own Promotional Review Committee reviews
Develop an understanding of the benefits and value of involving patients and caregivers in the drug and medical device development process
Compare AdPromo differences in specific country regulations and requirements
Discuss the various professional growth and career opportunities available in the advertising and promotion regulatory space

Program Committee

Micheline Awad, MBA • Senior Director, Regulatory Affairs - Advertising, Promotions, and Labeling
Turning Point Therapeutics, Inc., A Bristol Myers Squibb Company, United States
Sheetal Patel, PharmD • Vice President, Specialty Compliance
Johnson & Johnson, United States
Fadwa Almanakly, PharmD • Vice President & Head, Advertising and Promotion, Regulatory Affairs Americas
Bayer Pharmaceuticals, United States
Heather Banuelos, JD • Counsel
King & Spalding LLP, United States
Kimberly Belsky, MS • Executive Director Reg Policy & Intell, AdPromo, RegOps, Regulatory Affairs
Mallinckrodt Pharmaceuticals, United States
Robert Dean, MBA • Vice President Commercial Regulatory
Myovant Sciences, United States
Virginia Foley • Head of Marketing & Strategic Business Development Ad Promo - Practice Leader
Opus Regulatory Inc, 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
Dale Cooke, JD, MA • President
PhillyCooke Consulting , United States
Georgina Lee, PharmD • Senior Director, Regulatory Affairs
Sage Therapeutics, United States
Mark Gaydos • Vice President & Global Head, Advertising, Promotion & Labeling
Sanofi, United States
Wayne Pines • President, Health Care
APCO Worldwide Inc., United States
Lucy Rose, MBA • President
Lucy Rose and Associates, United States