概览

Conference: February 24-25, 2025 | In-Person

This conference delves into the evolving regulatory landscape for advertising and promotion of biopharmaceuticals and medical devices, with a focus on innovation, compliance, and patient-centric communication. Attendees will explore cutting-edge topics such as the application of artificial intelligence in promotional review, the distinction between scientific communication and promotion, and strategies for engaging diverse patient populations.

Join thought leaders from industry, legal, public affairs, and government for interactive discussions that will shape policy, define strategic priorities, and provide actionable insights into regulatory expectations and best practices.

Designed for professionals at all career stages, this conference offers a comprehensive understanding of current FDA policies, emerging trends in digital marketing and disease awareness campaigns, and practical tools for optimizing promotional review processes. Network with experts from the FDA, industry, and regulatory agencies to tackle the challenges and opportunities in today's fast-evolving advertising and promotion space.

Need Approval in Order to Attend?

Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.

Participant Testimonials

It was a great event. The speakers and panels were very informative, relevant, and organizedwell. It was also a wonderful opportunity to network and meet new individuals who work in thesame/similar role at other companies. – James Chang, Associate Manager Regulatory Advertising and Promotion, Astellas

This conference is a great opportunity to learn recent trends in our industry, and hear about exciting issues hot topics. It was so great to see everyone in person again as well and network. – Kavita Vazirani, Principal Consultant, Opus Regulatory, Inc.

All levels of regulatory A&P expertise can benefit from it. Besides educational presentations, the face-to-face social networking aspect of this event was exceptionally good. Breaks after every session helped us refreshed and focused. – Iram Quraishi, Director Regulatory A&P, Takeda

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学习目标

At the conclusion of this activity, participants should be able to:

Summarize the latest FDA policies, guidance documents, and regulations impacting advertising and promotion globally to ensure compliance
Identify strategies to address common pitfalls and ensure compliant advertising and promotion activities across traditional and digital platforms
Explore how artificial intelligence and machine learning can optimize the advertising and promotional review process while maintaining compliance
Differentiate between medical communication and promotion to effectively engage patients and advocacy groups within regulatory guidelines
Examine best practices for optimizing promotional review committees (PRCs) to support launch readiness and post-approval activities
Analyze emerging trends in digital transformation and regulatory expectations to prepare for the evolving landscape of healthcare promotion
Design and summarize compliant disease awareness campaigns that effectively engage target populations without promoting treatments
Plan and apply strategies to incorporate AdPromo regulatory insights early in brand planning to enhance campaign effectiveness

项目委员会

Catherine Gray, PharmD Director, Office of Prescription Drug Promotion, OMP, CDER
FDA, United States
Georgina Lee, PharmD Executive Director, Regulatory Advertising and Promotion
Sage Therapeutics, United States
Lynn Bowen, PhD Vice President, Regulatory Affairs Advertising Promotion & Labeling
Alkermes, Inc., United States
Anthony Genovese, PharmD Group Leader, Regulatory Advertising and Promotion
Johnson and Johnson, United States
Nicol Lorraine George, PharmD, RPh Vice President, Promotional Review & Labeling Services
ProPharma Group, United States
Moulakshi Roychowdhury, JD, PharmD Global Head, Regulatory Affairs, Advertising & Promotion, Allergan Aesthetics
AbbVie, United States
Virginia Foley VP Regulatory, Life Sciences & Healthcare
Constellation, United States
Stephen Shinall, PhD Director of Regulatory Affairs
Biogen, United States
Zoe Dunn President & CEO
Hale Advisors, Inc., United States
Heta Zaveri Practice Leader- Advertising and Promotion
Opus Regulatory, United States
Twyla Mosey, PharmD Division Director
FDA, United States
Representative Invited DIA, United States
Mark Gaydos Former Global Head, Advertising & Promotion, Global Regulatory Affairs
Sanofi, United States
Micheline Awad, MBA Sr. Director, Regulatory Advertising, Promotion, and Labeling
Day One Biopharmaceuticals, United States