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Wednesday, June 15 • 10:00am - 1:00pm
31A: Global AdPromo: Considerations for Compliance and Success

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Component Type: Tutorial
CE: ACPE 2.75 Knowledge UAN: 0286-0000-22-505-L04-P ; CME 2.75; IACET 2.75; RN 2.75

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Navigating a global advertising and promotion function can be challenging. Creating a compliant and flexible process while bearing in mind regional and country differences along with ensuring processes are not “US-centric” is a common challenge faced by sponsors. Focusing on the EU and Canada, this session will address the foundational regulatory and legal requirements, provide insights into best practices for a global adpromo process, and using case studies and examples, highlight key pitfalls and how to overcome them. The presenters will address the biggest questions faced by sponsors today (eg, direct to consumer messaging, press releases, social media, advertising and promotion v. information, corporate websites) to ensure the development of globally compliant materials while reducing burden on the company.


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  • Presentation Slides


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Who should attend?

Professionals with intermediate to advanced knowledge of, and experience in, advertising and promotion and who are involved in: Benefit-risk assessment and communication, Medical product safety assessment, Post-market studies and Real-world evidence generation, Regulatory affairs, Medical information, Medical Communications, Medical Affairs, Corporate and Commercial Communications, Customer Engagement Programs, including Patient Support Programs.

Learning Objectives

At the conclusion of this short course, participants should be able to:
  • Identify various country and regional approaches in the review committee organization and representation
  • Discuss common advertising and promotion pitfalls
  • Describe key regulatory and legal advertising and promotion requirements for EU and Canada



Moderators
avatar for Kimberly Belsky

Kimberly Belsky

Executive Director Reg Policy & Intelligence, AdPromo, RegOps, Regulatory Affair, Mallinckrodt Pharmaceuticals, United States
Kimberly (Kim) Belsky is the Executive Director of Regulatory Policy & Intelligence, AdPromo and RegOps at Mallinckrodt Pharmaceuticals. With over 30 years of global experience in the medical product industry, including 20+ years in regulatory affairs, Kim's diverse experience including... Read More →

Speakers
KT

Karen Timmins

Senior Director, Head of Regulatory International Advertising and Promotion, GRA, Takeda, Switzerland
Karen joined the pharmaceutical industry in 2002, following a successful career in teaching and worked in various sales and marketing roles at Eli Lilly Ireland, BMS, Lilly UK and Shire. Following a successful launch of Elvanse in the UK in 2013 Karen and her family relocated to Zug... Read More →
avatar for Erik Vollebregt

Erik Vollebregt

Partner, AXON Lawyers, Netherlands
Erik's practice focuses on (medical) technology, pharmaceuticals, healthcare and life sciences in regulatory matters and he is active in litigation, commercial and transactional work in all of these fields.
avatar for John Wong

John Wong

Director, Scientific Affairs and Medical Information, TPIreg/ Innomar Strategies, an AmerisourceBergen Company, Canada
John Wong is a pharmacist graduate from Université Laval, Quebec, Canada. He started his career at the Toronto General as an Oncology Pharmacist. In 1998, he joined the Pharmaceutical Advertising Advisory Board (PAAB), a national regulatory body for the review of drug advertising... Read More →


Wednesday June 15, 2022 10:00am - 1:00pm CDT
Virtual McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  20: Short Courses, Tutorial |   09: Regulatory, Tutorial
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial