ComplianceOnline, Online Event
Why Should You Attend:
In the last few years, FDA found some IRBs to be highly deficient in compliance leading to Warning Letters and even closure of a few. A deficient IRB not only delays a clinical trial progress but if found during the conduct or after a trial is over could lead to major losses in data, time and cost, not to mention the loss in credibility of the sponsor with the FDA for not assuring compliance of all parties involved in their clinical trials. Recently FDA released a new guidance document describing its expectation from IRBs.
This course will list the criteria for evaluating the compliance status of the IRB supervising your clinical trial sites based on FDA’s latest guidance document. We will discuss current regulations and guidance documents governing IRB responsibilities, roles, common FDA concerns, and acceptable solutions. The presenter will use a case-study approach to explain common compliance deficiencies and solutions for addressing them.
Areas Covered in the Webinar:
- Current FDA regulations regarding IRBs.
- FDA’s audit history of IRBs with key findings.
- The latest guidance documents from FDA regarding IRBs.
- Importance of IRB registration with FDA and independent certification.
- FDA and Sponsor’s expectations from an IRB.
- Acceptable IRB functions, documentations and review fees.
- Audits by an IRB of a clinical investigator.
- Audits of IRB functions by sponsors
- Processes for creating an IRB
||Dr. Mukesh Kumar, is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He and leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD. His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has been involved in about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe and Asia. He has conducted numerous training workshops in FDA compliance related issues.