Designed by Advertising and Promotion professionals for Advertising and Promotion professionals – as well as their legal, marketing, and consulting colleagues -- DIA’s Advertising and Promotion Regulatory Affairs Conference offers a comprehensive agenda for beginners to the field as well as the most experienced. The conference, which has taken place annually for 30 years, delivers a multi-stakeholder perspective on new FDA guidances and the latest enforcement, the challenges of marketing pharmaceuticals and medical devices in a mobile-first world, and new technologies relevant to the promotion of FDA-regulated products. Industry and government thought leaders will facilitate interactive, forward-looking discussions that will shape policy, advance understanding, and define strategic priorities within the ad promo regulatory space.
Program Update! FDA publishes 2 final guidances that provide greater clarity about their thinking and recommendations for certain medical product communications. Register to learn how these are being incorporated into the 2019 program.
NEW! This year’s event will host a special “eSubmissions Table” alongside the exhibitors where the FDA OPDP eCTD team will be available to answer questions related to OPDP’s Draft eCTD Guidance. The FDA OPDP eCTD Team can discuss any topics and questions related to content and formatting of Electronic Promotional Submissions in eCTD format. Additionally, the FDA OPDP eCTD Team can provide instructions for submitting test files in eCTD format.
*FDA attendance is pending government approval.
On-Demand Content Preview WebinarNavigating Key FDA Advertising and Promotion Developments in a New Year
As a prelude to DIA’s Advertising and Promotion Regulatory Affairs Conference, this webinar, will begin with a brief year in review of the latest regulatory activities in this space, followed by a deeper dive into emerging regulations and policies for DTC communications.
Who should attend?
Professionals in pharmaceutical, biologics, and medical device companies involved in:
- Regulatory Affairs
- Medical Information and Affairs
- Senior Management
At the end of this conference participants should be able to:
- Discuss the latest FDA policies, guidances and how they apply on a practical basis to day to day oversight of ad promo materials for pharmaceuticals, biological products and medical devices
- Describe how other companies are interpreting policies and applying them to the current marketplace
- Recognize the latest policies and emerging regulations with regard to direct to consumer promotion and advertising
- Apply the latest policies to better communicate with all audiences, including payer discussions
- Select and implement effective digital and social media strategies to meet the challenges of ensuring compliance with FDA regulatory requirements
Micheline Awad, MBA • Director Regulatory Affairs, Advertising and Promotion
Neurocrine Biosciences, Inc., United States
Glenn N. Byrd, MBA, RAC • President
GByrd Ad-Promo Solutions, LLC, United States
Dale Cooke, JD, MA • President
PhillyCooke Consulting , United States
Mark Gaydos • VP, NA Marketed Product Strategy & Maintenance/US Advertising & Promotion
Sanofi, United States
Sheetal Patel, PharmD • Head, Regulatory Advertising and Promotion
Johnson & Johnson International, United States
Michele Sharp, PharmD • Senior Director, Global Regulatory Affairs
Eli Lilly and Company, United States
Thomas W. Abrams, MBA, RPh • Director, Office of Prescription Drug Promotion, OMP, CDER
FDA, United States
Wayne L. Pines • President, Regulatory Services and Healthcare
APCO Worldwide Inc., United States
Lucy Rose, MBA • President
Lucy Rose and Associates, LLC, United States