This Course covers FDA's statutory and regulatory requirements governing the development and use of investigational drug products for first-in-human clinical trials. It will provide a comprehensive look at the Current Good Manufacturing Practices (cGMPs) applicable to early stage human clinical testing from beginning to end. Several general categories will be covered including amongst others, Preclinical Testing Considerations, cGMPs for Phase I Investigational Drugs, the Regulation of Biologics for Investigational Use, and Human Clinical Trial Considerations. Attention will also be given to the specific rules applicable to each of these categories. Finally, the presenter will offer strategies for compliance with applicable Phase I Clinical Testing obligations and for mitigating the risk of Agency enforcement action. A time for participant questions will be provided.
Attendees will leave the Course clearly understanding the Processes and cGMP Requirements for parties sponsoring and conducting "first-in-human" Phase I Clinical Trials. The webinar is intended to provide participants with an understanding of:
Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment
Recorded video session
Karl M. Nobert focuses his practice on the representation and counseling of clients in the food and drug industry including advising clients on matters related to the regulation of human prescription and nonprescription drugs, human and veterinary biological products including regenerative medicine, medical devices, food and dietary supplements. Karl also assists clients with the preparation of FDA submissions including human and veterinary new drug and generic drug applications; 510(k) premarket notifications, premarket approval applications, recalls and market withdrawals, GRAS self-affirmations and notifications, and product listings and establishment registrations. He represents clients before the Food and Drug Administration (FDA), United States Department of Agriculture (USDA) and Federal Trade Commission (FTC). Karl also represents clients in State food and drug law matters on various regulatory matters including wholesaler/distributor licensing and registration. Karl currently serves as Legal Advisor to the International Veterinary Regenerative Medicine Society (IVRMS) and is a member of the National Thoroughbred Racing Association’s (NTRA) Safety and Integrity Alliance Subcommittee on Aftercare. He is the author of numerous articles and frequently presents on various FDA regulatory topics.