American Conference Institute’s Advanced Legal, Regulatory and Compliance Forum on Over the Counter Drugs will gather leading OTC drug industry stakeholders to discuss the major changes on Monograph Reform on February 26, 2021.

This is the only advanced legal and regulatory gathering specifically designed to provide practical insights on enforcement activity and preventative measures for the non-prescription drug industry.

Monograph reform under the CARES Act with its intended purpose being to bring forward a system that is more responsive to safety and efficacy issues while also encouraging innovation has been an industry game changer.

Attend this event and decipher what monograph reform means for the industry and walk away with best practices for regulatory roll outs other prominent shifts in the compliance.

WHAT TO EXPECT AT OUR NEW VIRTUAL CONFERENCE
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Enjoy an Easy to Use, Dynamic Online Platform

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Immerse Yourself in Live Presentations and Panel Discussions

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Engage with Attendees and Speakers in an Interactive Format

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Meet 1-on-1 with Your Fellow Attendees

CONFERENCE CO-CHAIRS
Speaker Name

Diane McEnroe

Partner
Sidley Austin LLP

Speaker Name

Renuka Singh

Senior Legal Counsel
Reckitt Benckiser

Featured Speakers
Speaker Name

Todd Halpern

Assistant General Counsel
GSK

Speaker Name

Erin Leslie

Assistant General Counsel
Sanofi

Speaker Name

David Grob

Director, Regulatory Affairs
Avrio Health

THIS YEAR’S HIGHLIGHTS
  1. Learn what to expect how to best prepare for monograph reform with guidance from the FDA and seasoned industry experts
  2. Navigating COVID related claims and recall activity
  3. Identify the labeling and manufacturing missteps when importing to avoid costly hold ups at the border with
  4. Comprehend why OTC patent protection has implications beyond IP
  5. Extract lessons from recent Rx-to-OTC switch success stories and learn how to overcome complex legal and regulatory hurdles
WHO YOU WILL MEET
  • OTC or Non-Prescription Drug Industry
    1. In-House Counsel, including generalists and those having responsibility for regulatory; IP, Patents and Trademarks; Licensing and Business Development
    2. Officers, Directors and Executives for Regulatory Affairs; Business Development, and Rx to OTC switches

  • Prescription Drug Industry
    1. In-House Counsel having responsibility for Rx to OTC switches, regulatory and patents
    2. Officers, Directors and Executives for Regulatory Affairs and Business Development

  • Law Firm Attorneys for the OTC and Prescription Drug Industry whose practices focus on:
    1. FDA and food and drug law
    2. IP, patents
CLE ACCREDITATION

Accreditation will be sought in those jurisdictions by the registrants which have continuing education requirements. This course is identified as nontransitional for the purposes of CLE accreditation. Learn more.

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