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

Topics

• 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

Who should Attend

• 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