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Advertising and Promotion Regulatory Affairs Resource Kit
To support continuous learning, DIA brings you complimentary digital downloads to spur thought, reflection, collaboration, and action. Download our Advertising and Promotion Regulatory Affairs Resource Kit to gain access to intriguing articles, exclusive podcast interviews, session recordings from DIA events, and more! Check back often, as we are continuously adding new content!
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Pricing Pitfalls in Prescription Drug Advertising
Should prescription drug or device advertisements include their price? “I don’t know how patients will perceive that because they won’t really know the difference between what they may or may not end up paying,” suggests Micheline Awad, Director, Regulatory Affairs, Advertising & Promotion, Neurocrine Biosciences, Inc. “We really haven’t studied in any systematic way the impact on the patient or on drug use or on being more transparent about drug prices,” explains Wayne Pines, President, Regulatory Services & Healthcare, APCO Worldwide, Inc. Micheline and Wayne served on DIA's Advertising and Promotion Regulatory Affairs 2019 program committee.
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Ad/Promo eCTD Submissions Round Table
The Ad/Promo eCTD Submissions Round Table will present the experiences and perspectives of three companies who have transitioned their Ad/Promo Submission process to eCTD format. The panel features representatives from Eli Lilly, Otsuka, and Agios and is moderated by the Office of Prescription Drug Promotion. Each panel member provides an overview of their path to Ad/Promo eCTD adoption while also discussing challenges and lessons learned along the way.
How is FDA enhancing the incorporation of the patient voice in medical product and regulatory decision-making? Check out our infographic: An FDA Patient-Focused Drug Development (PFDD) Guidance Series.