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

Marina Malikova

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$349


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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.

Course Objective

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. We will discuss common deficiencies identified by FDA auditors during review of TMFs and provide potential solutions to the same. We will also discuss issues related to the kind of products being tested, responsibilities of individuals, resources available, and projected trends for the near future.

Course Outline

  • 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

Target Audience

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
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment


Recorded video

Recorded video session



Speaker: Marina Malikova, Executive Director, Surgical Translational Research

Dr. Malikova has over 15 years of experience in the clinical research field.  She has managed Phase I – IV studies involving investigational drugs, devices, biologics and combination products.  She has worked on Industry-sponsored and Investigator-initiated trials in the fields of Surgery, Cancer Diagnostics and Interventional Radiology.

Dr. Malikova graduated from the Institute of Biochemistry, Russian Academy of Science, in Moscow, Russia with a PhD in Biochemistry. She has a strong background in biomedical sciences and has completed her postdoctoral fellowship in the field of cell signaling and cell migration.  She also holds a Master’s Degree in Clinical Investigation, Certification in Project Management from Boston University and dual board certified in Regulatory Affairs (RAC) for pharmaceutical products and medical devices by Regulatory Affairs Professionals Society (RAPS).

She also holds professional certification in Clinical Safety and Pharmacovigilance by Drug Information Association (DIA).

In her current role as Executive Director, Dr. Malikova manages research efforts in 13 divisions of the Department of Surgery at Boston Medical Center.  She is responsible for clinical research operations, financial management, quality assurance, risk management, strategic planning, compliance assurance and macro-management of research programs. 

Dr. Malikova has 12 years of teaching experience as an Instructor for Clinical and Biomedical Sciences Program, Metropolitan College. She has developed and taught several courses such as: Design and Conduct of Clinical Trials, Drug Development, Introductory Pharmacology, Clinical Trials Management at Boston University, School of Medicine.

She also served as an Instructor of the Good Clinical Practices (GCPs) course for the Master of Science Program in Clinical Investigation, Division of Graduate Medical Sciences, Boston University, School of Medicine.

Dr. Malikova is a member of Association for Clinical Research Professionals (ACRP), Drug Information Association (DIA), Regulatory Affairs Professionals Society (RAPS) and European Society of Radiology (ESR).


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