- OVERVIEW AND WHY SHOULD YOU ATTEND
- AREAS COVERED AND LEARNING OBJECTIVES
- WHO WILL BENEFIT
The webinar will offer an overview of FDA requirements for marketing, labelling and promotion of OTC drugs in the U.S. It will cover how OTC pharmacy can be effectively marketed and the OTC Monographs and their importance to compliance in general and drug labels in particular. Challenges of marketing OTC drugs in the U.S. will be covered.
why should you attend
Attendance is important to assure that your OTC drug products are in compliance with FDA food regulations and to learn about how the OTC monographs can help you market your drug products effectively. Helpful references to websites and relevant regulations and know-how tips will also be provided.Click to View the Pricing Plan
• Background and History of OTC Drug regulations
• Different Ways that OTC Drugs can be Marketed in the U.S. (NDA, Rx to OTC Switch vs. Monograph process)
• Overview of the OTC Drug Monographs and Their Importance
• FDA Drug Facts Labelling Requirements
• FDA Regulations for Required Adverse Event Reporting
• To become familiar with FDA regulations for marketing OTC drugs in the U.S.
• In-turn assure compliance and more effectively market OTC products
WHO WILL BENEFIT
• Regulatory Affairs Managers and Associates
• QA Managers
• OTC Drug Marketing Managers
• Anyone interested in learning about U. S. OTC Drug regulatory requirements and compliance
Norma Skolnik has over 35 years of regulatory experience working with the pharmaceutical and dietary supplement industries. She served as Director of Regulatory Affairs for the Americas for Cadbury Adams. Prior to that she was Director of Regulatory Affairs for the Adams Division of Pfizer and Associate Director Of Regulatory Affairs for the Warner-Lambert company. She also served as Director of Regulatory Affairs for Lederle Consumer Healthcare and as Associate Director of Marketed Product Support for Lederle Laboratories and Associate Director of Regulatory Affairs for Wyeth.View all trainings by this speaker
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Thank you for the spreadsheet webinar. The webinar was informative and helpful. Although many of the concepts are known and understood by Industrial and Process Engineers, it is always helpful to have a straightforward review. The spreadsheet will be beneficial in being able to help identify areas of risk and areas that may require some attention.
Benchmark Electronics , ******** Engineer
This was a very informative session, it did help my company by raising awareness in areas we lack policies. The only thing I would suggest get added to the session is direct information relating to Accounting, ex. Taxation rules for record retention as they are some records which a company is required to keep indefinitely.
First MCO, ***** Manager
Overall I found the video conference well organized and very informative. The presenter, Ronald Adler, was certainly extremely knowledgeable and presented the subject matter in a well organized, direct and succinct manner. Afford the attendee the ability to track and record paid attendance/activity without a lot of tracking and follow up in order to gather the necessary information required to record the CPEs earned and paid for.
Dynamic Marketing Systems, VP Finance & Human Resources
As this was our first experience, we did not know what to expect. I believe the webinar was informative and to the point, and explained to us the purpose of the I-9, and how the company can be affected by an audit. It really motivated us to review our files and bring them up to date.
Young Transportation, ****Coach****
I have participated in several webinars hosted by Compliance Global on various H&S topics. They are always precise, technologically-oriented, and easy to use and partake in to further my knowledge of current Health and Safety regulations and topics.