Life Science Advertising & Promotion Regulatory Affairs Professional Education Course
July 16-17, 2024 | Virtual Course
All Times Central US
Life Science Advertising & Promotion Regulatory Affairs Professional Education Course
July 16-17, 2024
Virtual Course
All Times Central US
Increasing Ad/Promo Effectiveness by Overcoming Challenges in Online Promotion & the Use of Social Media, all while Clarifying Gray Areas in the FDA CFL Guidance to Ensure Ongoing Compliance
Senior Director
RHYTHM PHARMACEUTICAL
Director, Regulatory Affairs U.S. Advertising and Promotion
ABBVIE INC
Alicia Whittlesey
Principal Attorney
PORZIO, BROMBERG, & NEWMAN
Director, Regulatory Advertising & Promotion
NOVARTIS
Sr Manager, Advertising and Promotion Compliance
LUNDBECK
Advertising and Promotional Compliance
ALEXION PHARMACEUTICALS
Principal Attorney
KULKARNI LAW FIRM
Senior Director, US Regulatory Advertising & Promotion
TAKEDA PHARMACEUTICALS
Marci Schentzel
Executive Director of Ad/Promo
IMMUNOGEN/NOW ABBVIE
Partner
FOLEY & LARDNER
Principal Attorney
PORZIO, BROMBERG, & NEWMAN
Regulatory Counsel
FDA
Senior Director, US Promotional Regulatory Affairs
JAZZ PHARMACEUTICALS
9:00 ZOOM SIGN-ON & VIRTUAL PROGRAM WELCOME
• Private & public text chat
• Interactive polling
• Tech check
9:20 OPENING REMARKS
9:30 PANEL DISCUSSION: INTERDEPARTMENTAL COLLABORATION STRATEGIES FOR ENHANCED EFFICIENCY DURING PRODUCT LAUNCHES
• Soft skill approaches for collaboration and efficiency
• Ensuring team members know functions and processes
• Practical steps to bringing unity and respect
• Effective strategies for marketing and reviewers
Gary Wieczorek, ABBVIE INC.
Nick Senior, NOVARTIS
Vera Makar, JAZZ PHARMACEUTICALS
10:15 STRIKING A BALANCE: LEVERAGING EDUCATION AND ADVERTISING IN PHARMACEUTICAL PROMOTION
• Informative content for consumer understanding of product benefits
• Implementing compelling messaging for consumer `engagement
• Compliance with regulatory standards in advertising materials
• Effectiveness of educational and advertising strategies through analytical insights
Kyle Faget, Partner
FOLEY & LARDNER
11:00 VIRTUAL NETWORKING & COFFEE BREAK
11:30 CASE STUDY: LEVERAGING ADVERTISING AND MODULAR CONTENT TO DEVELOP EFFICIENT REVIEW PROCESS STRATEGIES
• Assessing the current status of manpower and resources utilized
• Identifying challenges encountered during the product marketing phase
• Implementing practical steps to maintain the relevance of advertising
• Modular content use in product post-launch assessment phase
Alexander Zachos, Director, US Regulatory Advertising & Promotion
TAKEDA PHARMACEUTICALS
12:15 COMPLIANCE CONSIDERATIONS FOR PROMOTIONAL REVIEW COMMITTEES
• Recognize and address the risks in patient assistance programs and royalty payments before they escalate
• Understand the need for a compliance program tailored to the unique needs of promotional review
• Understand how PRC compliance impacts the due diligence phase of M&A
Darshan Kulkarni, Principal Attorney
KULKARNI LAW FIRM
1:00 ACCELERATED APPROVAL PRODUCTS: REGULATORY CONSIDERATIONS AND BEST PRACTICES
• The regulations – what’s required, understanding accelerated approval requirements
• Getting organized, plan in advance, and work with all stakeholders
• Develop the infrastructure, processes, systems and training
• Pre FDA approval requirements
• Post-approval requirements
Daisy Chhatwal, Senior Director, Regulatory Strategy
RHYTHM PHARMACEUTICAL
Marci Schentzel, Executive Director
ADVERTISING AND PROMOTION IMMUNOGEN/NOW
1:45 MODULE ONE CONCLUSION
Day Two Agenda
Wednesday, July 17
All Times Central US
9:00 ZOOM SIGN-ON & VIRTUAL PROGRAM WELCOME
• Private & public text chat
• Interactive polling
• Tech check
9:20 OPENING REMARKS
9:30 PANEL DISCUSSION: ACHIEVING SUCCESS IN SOCIAL MEDIA: STRATEGIES FOR LEVERAGING A ROBUST SOCIAL MEDIA CAMPAIGN
• Reviewing FDA’s guidelines and addressing regulatory gaps
• Integration of websites and traditional media channels
• Examine submission processes, reporting requirements, and other protocols
• Assessing platform limitations and staying informed about updates
Michelle Belliveau, ALEXION PHARMACEUTICALS
Rebecca Torres, LUNDBECK
Alexander Zachos, TAKEDA PHARMACEUTICALS
10:15 THE FUTURE OF AI IN PHARMA PROMOTION: OPPORTUNITIES AND CHALLENGES
• Understanding the legal implications of data ownership, addressing biases in AI algorithms.
• Discuss the regulatory complexity of using AI technologies.
• Discuss the application-specific considerations including discussing endorsements, deep fakes, etc.
Darshan Kulkarni, Principal Attorney
KULKARNI LAW FIRM
11:00 VIRTUAL NETWORKING & COFFEE BREAK
11:30 UPDATED FDA ENFORCEMENT TRENDS AND INCREASED IN AD/PROMO RELATED WARNING LETTERS
• Effective compliance training for marketing with a focus on legal and review processes
• Understanding OPDP’s more rigorous approach to CFL communications
• Common trends that follow the recent causes for issuing Untitled Letters
• External pressures to update old social media rules to impact enforcement
Jennifer Romanski, Principal Attorney
PORZIO, BROMBERG, NEWMAN
Alicia Whittlesey, Principal Attorney
PORZIO, BROMBERG, & NEWMAN
12:15 DECODING FDA REGULATIONS: CLEAR, CONSPICUOUS AND NEUTRAL
• Breaking down the key components of the regulatory guidance
• Initial rollout for the recent FDA regulation enactment
• Preparation strategies to ensure compliance with new guidance
• Legal misconceptions to be aware of while re-aligning timeline to new regulations
Suzanna Boyle, FDA Counsel
FDA
1:00 Closing Remarks & Professional Education Course Conclusion
Previous Attendees Include:
Associate Chief Counsel – FDA & Counsel, KING & SPALDING
Associate Director of Global Marketing Excellence, UCB PHARMA
Associate Director Oncology, Promotion & Advertising, W. L. GORE
Associate Director, KING & SPALDING
Associate Director, Advertising & Promotion, BAYER HEALTHCARE
Associate Director, Regulatory Affairs – Commercialization, DERMIRA
Associate, HOGAN LOVELLS
Co-Founder and Managing Partner, GOVISE
Counsel, FDA & Life Sciences, KING & SPALDING
Director of Advertising & Promotion, SAGE THERAPEUTICS
Director, Account Solutions, FRAMEWORK SOLUTIONS
Director, Advertising & Promotion Regulatory, TAKEDA
Director, Advertising and Promotion, REGENERON PHARMACEUTICALS
Director, Regulatory Affairs Advertising & Promotion, ABBOTT
Director, Promotion Compliance, OTSUKA PHARMACEUTICAL
Director, International Regulatory Affairs, ABBVIE
Director, Office of Promotion and Advertising Review, MERCK
Director, Regulatory Advertising & Promotion, NOVARTIS
Director, Regulatory Affairs U.S. Advertising and Promotion, ABBVIE
Director, Regulatory Affairs US Policy, CELGENE
Director, Advertising & Promotion, HORIZON PHARMA
Director, US Regulatory Affairs Advertising & Promotion, ABBVIE
Executive Director, Labeling & Promo, INTERCEPT PHARMACEUTICALS
Global Regulatory Affairs Labeling & Ad/Promo, W.L. GORE
Lecturer, UNIVERSITY OF SOUTHERN CALIFORNIA
Manager, Advertising and Promotion Compliance, ABBVIE
Partner, ARNALL GOLDEN GREGORY
Principle Consultant, Regulatory Affairs, OPUS REGULATORY
Promotion Design Specialist, PERRIGO
Regulatory Operations/FDA Submissions, VALEANT PHARMACEUTICALS
Senior Associate, ARNOLD PORTER
Senior Director of Marketing, HOGAN LOVELLS
Senior Directory Affairs, Advertising & Promotion, ARRAY BIOPHARMA
Senior Director, Promotional Regulatory Affairs, ASTRAZENECA
Senior Director Regulatory Advertising & Promotion, VERASTEM ONCOLOGY
Senior Director, Regulatory Affairs, LUNDBECK
Senior Director, Regulatory Strategy, BLUEBIRD BIO
Senior Manager Regulatory Affairs, PACIRA PHARMACEUTICALS
Senior Manager, Advertising and Promotion Compliance, MERCK
U.S. General Counsel, SPARK THERAPEUTICS
….And Many Many More
Who should attend:
VP’s, Directors and Managers of:
- Advertising & Promotion (Ad/Promo) Regulatory Affairs
- Regulatory Advertising & Promotional Review
- Regulatory Affairs Advertising, Promotion & Labeling
- Regulatory Affairs, Commercialization
- Marketing
