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Managing FDA GCP/Bioresearch Monitoring Inspections
Clinical trial principal investigators and sponsors have their very own dedicated team of FDA inspectors, the Bioresearch Monitoring (BIMO) program staff. Washington public policy lawyer, David Rosen, has made a study of their inspection practices. He’s sharing his insights ... with you.
This fast-paced 90-minute presentation covers everything PIs and sponsors need to know about BIMO inspections:
Get inside the BIMO inspector’s head ... for hassle-free inspection visits, an end to writeups, and improved clinical practice in the bargain.
The topic under discussion is one that affects drug, biologics and device makers as well as CROs. Interested parties may include:
David Rosen Esq., co-chair of the Life Sciences Industry Team of Foley & Lardner LLP, specializes in health law, life science and food and drug regulation with a focus on drugs, devices and biologics. An FDAer for 14 years, he held supervisory positions in virtually every aspect of the approval process for drugs and combination products, as well as jurisdictional issues and related compliance activities. He is also a member of Foley & Lardner’s Government & Public Policy Practice and Health Care and Food & Beverage Industry teams.
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