2nd Annual Life Science Advertising and Promotion Regulatory Affairs Conference

July, 2020 | Arlington, VA

2nd Annual Life Science Advertising and Promotion Regulatory Affairs Conference
July, 2020 | Arlington, VA

Request Invite

WE GUARANTEE 100% PRIVACY, YOUR INFORMATION WILL NOT BE SHARED

“Loved the small group dynamic.”

Director, Office of Promotion and Advertising Review
Merck

“The rich and diverse experience represented in the room brought together different perspectives and great discussion.”

Director, Regulatory Affairs, Advertising & Promotion
Sage Therapeutics

“Very relevant to what we do. It was great to collaborate with others from all sizes of companies to get a better sense of how they operate. Thank you!”

Manager, Promotional Review Department
Janssen Biotech

“Very good group. Look forward to 2nd Annual Life Science Ad/Promo Regulatory Affairs Conference.”

Director, US Regulatory Advertising & Promotion
Takeda

“Lots of collaborative discussion. Nice discussion. Would come again.”

Associate Director, Regulatory Affairs – Advertising & Promotion
Bayer

About the Conference:

In the highly competitive life science environment, where companies seek to drive increased revenue through a wide range of advertising and marketing efforts including direct-to-consumer advertising, outreach at conventions and expos, medical education, social media, press releases, and more, advertising and promotions regulatory affairs executives face numerous challenges in the effort to remain compliant with FDA regulations and guidances. Recent FDA policy updates including the Medical Product Communications That Are Consistent With the FDA-Required Labeling guidance and the Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities guidance have added additional layers of uncertainty and given many advertising and promotions regulatory affairs professionals reason for caution, as the level of FDA’s enforcement of these guidances remains unclear.

Core Topics to be Addressed:

  • Compliantly aligning off-label promotional materials with FDA-approved label
  • Decreased FDA enforcement trends and the impact on risk assessments
  • Substantial vs. scientifically accurate & statistically sound evidence
  • Deciphering the role of real-world evidence in payer communications
  • Collaborative communication amongst promotional review committees

Program Highlights:

  • Deep dive into peers’ application of recent guidance
  • Engaging workshops & small group discussions
  • Focus on knowledge-share & participatory learning

Core Topics to be Addressed:

  • Compliantly aligning off-label promotional materials with FDA-approved label
  • Decreased FDA enforcement trends and the impact on risk assessments
  • Substantial vs. scientifically accurate & statistically sound evidence
  • Deciphering the role of real-world evidence in payer communications
  • Collaborative communication amongst promotional review committees

Request Invite

WE GUARANTEE 100% PRIVACY, YOUR INFORMATION WILL NOT BE SHARED

Audience

75 Attendees

All attendees come directly from life science companies

Distinguished Presenters

Speaker recruitment in progress

Networking

Networking time is built into the agenda to allow industry peers to connect and exchange ideas

Open Dialogue and Group Share

Each presentation is followed by 10-15 minutes of open dialogue for questions and exchange of best practices

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