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Sheraton Pentagon City Hotel

Mar 12, 2024 7:30 AM - Mar 13, 2024 3:55 PM

900 South Orme Street, Arlington, VA 22204, USA

Advertising and Promotion Regulatory Affairs Conference

Explore the current state of compliance for marketing both biopharmaceuticals and medical devices.

Session 10A: Global Ad Promo and Enforcement Insights

Session Chair(s)

Moulakshi  Roychowdhury, JD, PharmD

Moulakshi Roychowdhury, JD, PharmD

Global Head, Regulatory Affairs, Advertising & Promotion, Allergan Aesthetics

AbbVie, United States

During this session, panelists will provide insights into Regulatory Advertising and Promotional Compliance for pharmaceutical companies doing business outside the US. The presentation on enforcement will comprehensively cover global policies, guidance documents, guidelines, and regulations, exploring industry self-regulation on a global scale. It will delve into the standards applied and how companies support these efforts worldwide, providing insights into the structure of regulatory and review functions. Additionally, the discussion will focus on managing the review of corporate content on global platforms, taking into consideration geographic boundaries and implications for different regions.

The panel will consider perspectives from legal experts, the role of governing bodies like PMCPA in the UK, and delve into challenging-to-find information, such as examples from Health Canada/Canada. The discussion will also touch on avoiding global enforcement through an overarching international review team. This comprehensive overview aims to provide attendees with a nuanced understanding of the intricate landscape of global regulatory advertising and promotional compliance.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Analyze international Regulatory Ad Promo enforcement, with a potential focus on social media trends
  • Examine examples from HC/Canada for a deeper understanding
  • Discuss strategies for avoiding global enforcement through the establishment of an overarching international review team

Speaker(s)

Richard  Lem, PharmD

Global Review – a Strategic Enterprise Function

Richard Lem, PharmD

Abbvie, United States

Director, International Regulatory Affairs Advertising and Promotion

Audrey  Athlani Jorno, PharmD, MS

Understand What Promotional Compliance Means for Pharmaceutical Companies Looking to Market their Products in Europe

Audrey Athlani Jorno, PharmD, MS

Pharmalex, France

Associate Director, Promotional Materials & Compliance

Anne K. Walsh, JD

Global Compliance: Legal Implications & Best Practices

Anne K. Walsh, JD

Hyman, Phelps & McNamara, PC, United States

Director

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