Distinguish between a potential Rx pharmaceutical product and an OTC drug
How OTC Drug Products are regulated in the U.S
How to identify and successfully navigate an OTC Drug Monograph
The difference between the various pathways for commercializing an OTC Drug Product
How to determine whether an Ingredient is considered Safe or GRAS/E for use in an OTC Drug and understand the difference between Category I, II and II Ingredient designations
When reliance on a Proposed Rule, Final Rule and/or Drug Monograph is appropriate
Strategies for marketing and promoting OTC drug products, and for mitigating potential enforcement risks
The required elements of a compliant OTC Drug Label
Several of FDA`s current OTC Monographs
Working knowledge of the Rx-to-OTC Switch Process
Past Events
The Regulations of OTC Drugs 2017 - 19-20 Oct 2017, Newark, New Jersey, United States (70548)
Important
Please, check "The Regulations of OTC Drugs" official website for possible changes, before making any traveling arrangements
