Complex regulations govern the development, manufacture, and commercialization of biomedical products. This web seminar will help participants understand the U.S. regulatory requirements for patented and generic pharmaceuticals, over-the-counter drugs, biologicals, and medical device products. Participants will gain high-level knowledge and insight into the regulatory agencies and their roles and responsibilities, regulatory applications and pathways, and post-marketing requirements. This is an important course both for those entering the biomedical profession and for those already in the profession to learn more about the laws governing this industry.
- Examine FDA laws and the history of why they came into place
- Navigate key regulations that pertain to drug, biologic, and device development
- Describe how the FDA is organized
- Describe the roles and responsibilities of the FDA
- Navigate regulatory pathways for investigational products
- Regulatory Affairs Professionals
- Clinical Research Professionals
- Research and Development Professionals
- Manufacturing Personnel
- Project Managers
- Those who want an introduction to the FDA’s legislative process and background
Meredith Brown-Tuttle, R.A.C.
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$695
Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call 1-800-856-2556 for pricing.
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE#: 0778-0000-11-035-L01-P. Released: 2/11.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471