Legal, Regulatory and Compliance Forum on Over the Counter Drugs 2013

  • 29-30 Oct 2013
  • Carlton Hotel, Autograph Collection, New York City, NY, United States

Description

Legal, Regulatory and Compliance Forum on Over the Counter Drugs 2013 is a conference that covers topics such as:

  • How new technologies may cause new controversies in OTC labeling
  • How the NSURE (Nonprescription Safe Use Regulatory Expansion) Initiative may accelerate the approval of novel candidates for Rx-to-OTC switches
  • Why OTC patent protection has implications beyond IP
  • How the use of social media in the OTC space has blurred the boundaries between advertising and promotion and labeling
  • Product classifications for international OTC launches
  • The unique legal and regulatory challenges associated with natural OTCs and the homeopathic pharmacopeia
  • How recent FDA and DOJ — as well as FTC — enforcement in the OTC space will influence future trends and compliance obligations
  • Regulatory challenges associated with umbrella branding for monograph and NDA OTCs
  • Stringent GMP protocols that will help your company avoid fines, violations and enforcement activity
  • Effective recall execution strategies
  • In-Depth Analysis and Legal and Business Strategies for Bringing Your Product Over the Counter
  • Domestic and International OTCs and Consumer Health Care Products 101

Legal, Regulatory and Compliance Forum on Over the Counter Drugs 2013 brings together:

  • Prescription Drug Industry
    • Officers, Directors and Executives for Regulatory Affairs and Business Development
    • In-House Counsel having responsibility for Rx to OTC switches, regulatory and patents
  • OTC or Non-Prescription Drug Industry
    • Officers, Directors and Executives for Regulatory Affairs; Business Development, and Rx to OTC switches
    • In-House Counsel, including generalists and those having responsibility for regulatory; IP, Patents and Trademarks; Licensing and Business Development
  • Law Firm Attorneys for the OTC and Prescription Drug Industry whose practices focus on:
    • IP, patents, and Hatch-Waxman matters
    • FDA and food and drug law
    • Trademarks

Past Events

Important

Please, check "Legal, Regulatory and Compliance Forum on Over the Counter Drugs" official website for possible changes, before making any traveling arrangements

Event Categories

Government & Global Issues: Law & Regulations
Health & Medicine: Pharma

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