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