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.
Featured
Short Course or Primer
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Mar 04, 2022
Drug and Biologic Ad Promo Primer
Learn more
Who should attend?
Professionals involved in:
- Regulatory Affairs
- Marketing
- Communications
- Compliance
- Medical Information and Affairs
- Legal
- Patient Engagement
Learning objectives
- 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
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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 • Reg Policy & Intell and AdPromo, Regulatory Affairs
Independent, United States -
Bob Dean, MBA • Head of Global Labeling Strategy & Ad/Promo
EMD Serono, 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 • Executive Director, Regulatory Advertising and Promotion
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
Contact us
Registration Questions?
Preconference Short Courses
Drug and Biologic Ad Promo Primer
Discover DIA’s Live In-Person and On Demand Events
Advertising and Promotion Regulatory Affairs Conference Resource Kit
On-Demand Webinar
Avoid Unwanted Attention to Your Press Releases
Advertising and Promotion Regulatory Affairs Conference Infographic