March 8-9: Conference
*Primer requires separate registration.
DIA’s Advertising and Promotions (Ad Promo) Regulatory Affairs Conference offers a comprehensive agenda covering the latest updates in the ad promo regulatory space. Industry experts will share best practices for ad promo launch strategy, discuss global ad promo review considerations, and evaluate how clinical trial design impacts promotional practice. Hear from FDA on the latest OPDP draft guidance and initiatives, enforcement actions, social science research and electronic Common Technical Document (eCTD) submission process.
The conference delivers an overview of the current and future state of advertising and promotion, featuring perspectives from medical marketing agencies, regulatory, medical, and legal professionals. Whether you are new to the field or have years of experience, you can't afford to miss this opportunity to prepare yourself for what’s coming!
Complimentary WebinarNavigating the Still Murky Waters of Manufacturer Communications: Promotion, Commercial Speech, and Scientific Exchange
January 17 | 11:00AM-12:00PM ET
During this webinar we will examine how companies can proactively communicate outside the information expressly contained in a product’s approved full prescribing information and consider where companies might consider altering their traditional policies and where it may be prudent to continue exercising caution.
Preconference Primer on Wednesday, March 7
- Ad Promo Primer
- If you are new, or relatively new, to the preparation or review of advertising and/or promotional materials, this primer is for you! This course is designed to provide background information for you to better understand the conference content. The leaders will provide an introductory foundation for anyone working in our current regulatory environment. Whether you are a regulatory, legal, medical, compliance, or marketing professional, the information will be interesting, practical, and vital.
- Two breakout tracks to accommodate both novice and senior professionals
- A prep course on March 7 for even more educational opportunities
- Creative and interactive sessions with speakers from FDA and industry experts
- Exhibit Hall with numerous vendors displaying new solutions and services
At the end of this conference participants should be able to:
- Identify the trends reflected in the latest enforcement actions and policies issued by the FDA and other legal and regulatory authorities
- Discuss gaps in regulatory policy
- Examine the compliance challenges companies face, including how to evaluate challenges, and factors to consider that may impact the development of solutions
- Discuss the best US and global review and approval practices
- Describe emerging promotional and non-promotional tactics trending in the pharmaceutical industry that require creative and thoughtful regulatory review
- Analyze effective digital and social media strategies designed to meet the challenges of ensuring compliance with FDA regulatory requirements
Thomas W. Abrams, MBA • Director, Office of Prescription Drug Promotion, OMP, CDER
FDA, United States
Micheline Awad, MBA • Director Regulatory Affairs, Advertising and Promotion
Neurocrine Biosciences, Inc., United States
Glenn N. Byrd, MBA, RAC • Senior Director, Specialty Care Promotional Regulatory Affairs
AstraZeneca, United States
Dale Cooke, MA • President
PhillyCooke Consulting , United States
Mark Gaydos • VP, NA General Medicines/US Advertising and Promotion, Global Regulatory Affairs
Sanofi, United States
Mary L Raber Johnson, PhD, RAC • Assistant Professor, Clinical
The Ohio State UniversityCollege of Pharmacy, United States
Michele Sharp, PharmD • Senior Director, Global Regulatory Affairs - US
Eli Lilly and Company, 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
Complimantary WebinarNavigating the Still Murky Waters of Manufacturer Communications: Promotion, Commercial Speech, and Scientific Exchange
Jan. 17 | 11:00AM-12:00PM ET