Understanding the Regulatory Requirements for the Over the Counter (OTC) Drugs in the US
Description:-
- All drugs are reviewed and approved by the the FDA’s Center for Drug Evaluation and Research (CDER) before they can be consumed and used for human treatments. In as much as prescription drugs undergo heavy scrutiny, the same goes for over-the-counter drugs also known as non-prescription drugs.
- In order to introduce OTC drugs within the US market, there is need for deep understanding of the rules and regulations that govern drug production. This webinar conference is designed to help you develop a complete understanding of how OTC nonprescription drugs are developed and brought into the US market.
Area covered in the session :
- All laws and regulation pathways that regulate and govern OTC drugs in the US
- Key points in OTC drug development
- Requirements for OTC drug approval and consideration
- FDA actions during drug review
- OTC monographs
- FDA and FTC jurisdictions
- Recommendations for successful drug approval
Who will benefit ?
- CEO and managers
- Compliance officers
- Drug regulators and developers
- Clinical officers
- Attorneys
- Consultants
- Healthcare personnel
Presenter BIO
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor (www.RegulatoryDoctor.us). Dr. Lim is a leading industry speaker and has presented and addressed FDA regulatory and compliance matters in various forums and meetings.
Dr. Lim has helped both pharma and medical device industry for regulatory, clinical and compliance matters. Dr. Lim has also advised many firms including, but not limited to risk management firms, venture capital firms, asset management firms, and fund managers to make right investment decisions in view of FDA regulatory and compliance matters.
GET IN TOUCH
+1-800-935-3714 cs@onlineaudiotraining.com5042 Wilshire
Blvd #32898 Los Angeles
CA 90036
Monday to Friday
09:00 AM to 06:00 PM EST
Follow Us
Subscribe Now
& get 15% discount
on your first purchase!
01:00 PM EST 12:00 PM CST 11:00 AM MST 10:00 AM PST