At this training, speakers will review the laws and Food and Drug Administration regulations affecting the drug industry, establishing a foundation to help you and your organization get products approved and navigate regulatory problems. Experts will address the essential elements of FDA drug regulation in a systematic and comprehensive way. From the definition of “drug” to the different regulatory schemes for over-the-counter (OTC) and prescription (Rx) drugs, speakers walk you through key regulations and policies and will help you determine how those regulations and policies are applied. You will receive a broad overview of the FDA regulatory structure, the history of drug regulation, detail on specific areas such as the approval process, and gain an understanding of how FDA enforces and implements the laws passed by Congress. This program will also cover the latest topics and important new developments affecting the drug industry such as the Food and Drug Administration Safety and Innovation Act, risk management, Rx to OTC switches, brand-generic reform, regulation of marketing and manufacturing, enforcement and much more. At the end of this two day course, you will be prepared to think like an experienced drug law professional.
Who Should Attend?
You should attend this program if you are interested in an overview of drug and biologics law and regulation. The following personnel will benefit from attending this course:
- Regulatory and clinical affairs, research and development, quality control, marketing and management professionals of pharmaceutical companies
- Reviewers of new drug applications
- Associates working in law firms with a food and drug law practice, and other lawyers and consultants with an interest in drug issues
- Personnel in legal and compliance departments at pharmaceutical companies