Simplifying Global Compliance
Managing FDA GCP/Bioresearch Monitoring Inspections - Webinar Recording/Transcript
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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.
- How principal investigator inspections are handled: authority and administration protocols, IRBs, consent forms, study records, financial disclosures, and electronic records and signatures.
- How sponsor BIMO inspections are handled: registrations of studies, selection and monitoring of clinical investigators, selection of clinical research monitors, and quality assurance.
This fast-paced 90-minute presentation covers everything PIs and sponsors need to know about BIMO inspections:
- How BIMO inspections are started and conducted
- What the BIMO team is looking for in terms of following proper protocols for patient recruitment
- FDA-recommended best practices in execution of consent forms, and whether patient volunteers are actually eligible participants in a clinical trial
- How FDA determines whether you sufficiently identified PIs whose studies should have been or were terminated for non-compliance
- How the FDA knows if sponsors have ensured that IRB approval is properly obtained prior to clinical trial enrollment
- And much more!
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:
- Sponsors/CRO monitors
- Project managers
- Study coordinators
- QA/QR/QC
- Clinical investigators
- IRB personnel
- Regulatory affairs personnel
- Training personnel
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.