Advertising and Promotion Regulatory Affairs Meeting

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Overview

March 11: Primer
March 12-13: Forum

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. Representatives from across FDA’s Medical Product Offices will provide the latest information on guidance policies, enforcement actions, and future directions of industry hot topics such as pre-approval activities, labeling strategies, and social media tactics.

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 biopharmaceuticals, combo products and companion diagnostics. Attendees 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.

Keynote Address Announced!

The Patient Voice: Message and Impact on Healthcare

Theresa Mullin, PhD, Associate Director for Strategic Initiatives, OCD, CDER FDA, United States

Thursday, March 12 | 8:15-8:45AM
FDA recognizes that the patient perspective on new drug benefits and risks, and whether the disease burdens that matter most are addressed, is critically informative to regulatory decision-making. Drug development programs have often failed to explicitly account for the disease burdens and treatment burdens that would matter most to patients and fail to reliably measure these effects in clinical trials. FDA expects drug sponsors to incorporate the patient’s perspective starting early in development to ensure that the investigational product profile and development program incorporate clinical outcomes and endpoints that reflect what matters to patients. This session describes the background and content of a new FDA guidance series to foster patient focused drug development and sponsor use of such outcomes and endpoints. Reliable measures of what matters to patients and evidence of meaningful improvement will not only inform FDA decision making but may also better inform the decisions of other health authorities (e.g., HTA and payors).

Who should attend?

Professionals in pharmaceutical, biologics, and medical device companies involved in:

Regulatory Affairs
Marketing
Communications
Compliance
Medical Information and Affairs
Legal
Senior Management

Learning objectives

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 advertising and promotional materials for pharmaceuticals, biologics, generics, biosimilars, and medical devices
Describe how other companies are interpreting policies and applying them to their current marketing strategies
Recognize the differences between US FDA and other international regulatory policies regarding the promotion and advertising of medical devices
Apply the latest policies to better communicate with all audiences, including payers
Select and implement effective digital and social media strategies to meet the challenges of ensuring compliance with FDA regulatory requirements

Program Committee

Micheline Awad, MBA • Director Regulatory Affairs, Advertising and Promotion
Neurocrine Biosciences, Inc., United States
Kimberly Belsky, MS • Head of Regulatory Policy & Intelligence, Regulatory Affairs
Mallinckrodt Pharmaceuticals, 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
Joanne S Hawana, JD, MS • Member
Mintz Levin, United States
Mary L Raber Johnson, PhD, RAC • Assistant Professor, Clinical
The Ohio State UniversityCollege of Pharmacy, United States
Kevin M Madagan • Partner
Reed Smith, LLP, United States
Sheetal Patel, PharmD • Head, Regulatory Advertising and Promotion
Johnson & Johnson International, United States
Victoria Tamarkin, MS • Founder and Principal, Regulatory Compliance, Advertising and Promotion
Victoria Tamarkin Consulting LLC, 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