LEARN HOW THE U.S. FDA REGULATES VETERINARY MEDICA 2015 - Veterinary Medical Devices and FDA Regulatory Oversight

Website http://bit.ly/1t4rMNo | Edit Freely

Category FDA GXP Compliance - Medical Devices

Deadline: January 27, 2015 | Date: January 27, 2015

Venue/Country: Palo Alto, U.S.A

Updated: 2015-01-23 14:24:19 (GMT+9)

Call For Papers - CFP

Why Should You Attend:

The U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) has regulatory jurisdiction over veterinary medical devices and has shown little interest in the market sector based on the existence of historical enforcement action. However, with the growing marketing and promotion of injectable devices for horses and dogs, it is possible that such enforcement discretion may be abandoned for greater regulatory scrutiny and oversight.

Who Will Benefit:

This course is designed for individuals tasked with developing and maintaining an animal health company’s product portfolio that includes veterinary medical devices; and those responsible for overseeing a company’s regulatory strategies and mitigating possible FDA enforcement risk. This includes:

Division Directors and Chiefs

Business Development Team Members

Senior Quality Managers

Quality Professionals

Legal and Regulatory Professionals

Compliance Professionals

Labelers and Private Labelers

Contract Manufacturers

Instructor Profile:

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. Mr. Nobert 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.