Trial Master File (TMF): FDA Expectations from Sponsors and Sites

This training will review the essential elements of a TMF for clinical trials. The activities of set-up, maintenance, and monitoring will be discussed using case studies to highlight common deficiencies and potential solutions.

Why Should You Attend:

If you are involved in a clinical trial, either as a clinical site or a sponsor, this webinar will provide valuable suggestions about which documents are essential and which ones are not needed for an FDA audit. The instructor will discuss common deficiencies identified by FDA auditors during review of TMFs and provide potential solutions to the same.

This webinar will also discuss issues related to the kind of products being tested, responsibilities of individuals, resources available, and projected trends for the near future.

Areas Covered in the Webinar:

• FDA’s expectation from site and sponsor’s documents
• Required components of a TMF
• Best practices for the set-up and maintenance of TMF
• Electronic and Paper TMF requirements
• Common errors in TMF management

Who will benefit:

This webinar will provide valuable information to:

• Clinical Research Associates (CRAs)
• Clinical Research Coordinators (CRCs)
• Clinical Research Administrators
• Principal Investigators
• Project Managers
• Sponsors of INDs
• People investing in FDA-regulated product development projects

Instructor Profile:

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. He has authored numerous articles in peer-reviewed journals. He is a well known expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide. Dr. Kumar is a PhD in Biochemistry and has worked as a research scientist at the NIH, Baylor College of Medicine, Houston, and premier institutions in India. He is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA.