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Overview

March 4: Primer
March 8-9: Conference

DIA is offering a virtual conferencefor the Advertising and Promotion Regulatory Affairs Conference that allows you to view all the session recordings from the comfort of your own home/office. Can't make all the sessions live? You will receive access to the On Demand library with your registration for 2 months post-conference.

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.

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 medical products. You 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.



On-Demand Webinar

Avoid Unwanted Attention to Your Press Releases

Wednesday, February 2, 2022 | 12:00 – 1:00PM ET
This pre-event promotional webinar will address some of the issues companies are facing when developing press releases and why these communications can be challenging. The webinar will cover the historical regulation of Press Releases by the FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC)/Office of Prescription Drug Promotion (OPDP), draw key concepts from previous FDA enforcement and illustrate principles to avoid FDA action. The webinar will also frame the key legal and regulatory considerations companies should be aware of when issuing Press Releases.

Register Today

Who should attend?

Professionals involved in:

  • Regulatory Affairs
  • Marketing
  • Communications
  • Compliance
  • Medical Information and Affairs
  • Legal
  • Patient Engagement

Learning objectives

At the completion of this conference, the participant should be able to:
  • Discuss current regulatory/legal/compliance environment pertaining to the advertising and promotion of prescription drugs, vaccines, and biologics
  • Discuss the latest FDA policies, guidance’s, and how they apply on a practical basis to day to day oversight of advertising and promotional materials for biopharmaceuticals and medical products
  • Apply lessons from recent compliance actions to current advertising and promotion review work
  • Recognize material differences for disease awareness in unbranded and branded communications
  • Describe the regulatory framework for evaluating traditional and online DTC TV ads
  • Describe the role and objectives of the FDA on advertising and promotion issues
  • Apply key learnings and best practices shared by the panelists with their own Promotional Review Committee reviews
  • Develop an understanding of the benefits and value of involving patients and caregivers in the drug and medical device development process
  • Compare AdPromo differences in specific country regulations and requirements
  • Discuss the various professional growth and career opportunities available in the advertising and promotion regulatory space

Program Committee

  • Micheline  Awad, MBA
    Micheline Awad, MBA Senior Director, Regulatory Affairs - Advertising, Promotions, and Labeling
    Turning Point Therapeutics, Inc., United States
  • Sheetal  Patel, PharmD
    Sheetal Patel, PharmD Head, Compliance and Regulatory Advertising and Promotion
    Johnson & Johnson International, United States
  • Fadwa  Almanakly, PharmD
    Fadwa Almanakly, PharmD Vice President & Head, Advertising and Promotion, Regulatory Affairs Americas
    Bayer Pharmaceuticals, United States
  • Heather  Banuelos, JD
    Heather Banuelos, JD Counsel
    King & Spalding LLP, United States
  • Kimberly  Belsky, MS
    Kimberly Belsky, MS Executive Director Reg Policy & Intelligence, AdPromo, RegOps, Regulatory Affair
    Mallinckrodt Pharmaceuticals, United States
  • Robert  Dean, MBA
    Robert Dean, MBA Vice President Commercial Regulatory
    Myovant Sciences, United States
  • Virginia  Foley
    Virginia Foley Head of Marketing & Strategic Business Development
    Opus Regulatory, Inc., United States
  • Catherine  Gray, PharmD
    Catherine Gray, PharmD Director, Office of Prescription Drug Promotion, OMP, CDER
    FDA, United States
  • Joanne  Hawana, JD, MS
    Joanne Hawana, JD, MS Member
    Mintz, Levin, Cohn, Ferris, Glovsky & Popeo P.C., United States
  • Dale  Cooke, JD, MA
    Dale Cooke, JD, MA President
    PhillyCooke Consulting , United States
  • Georgina  Lee, PharmD
    Georgina Lee, PharmD Senior Director, Regulatory Affairs
    Sage Therapeutics, United States
  • Mark  Gaydos
    Mark Gaydos Vice President & Global Head, Advertising, Promotion & Labeling
    Sanofi, United States
  • Wayne  Pines
    Wayne Pines President, Health Care
    APCO Worldwide Inc., United States
  • Lucy  Rose, MBA
    Lucy Rose, MBA President
    Lucy Rose and Associates, United States
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