ComplianceOnline

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

Instructor: Marina Malikova
Product ID: 705759
Training Level: Intermediate
  • Duration: 60 Min

recorded version

$229.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Sep-2018

Training CD / USB Drive

$299.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367

Email: customercare@complianceonline.com

Read Frequently Asked Questions

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

Why Should You Attend:

This webinar is very much essential for Professionals involved in a clinical trials, either as a clinical site or a sponsor/CRO as it will provide valuable suggestions about which documents are essential according to FDA requirements for drugs, biologics and medical devices. The instructor will discuss common deficiencies identified by FDA auditors during review of TMFs and provide potential solutions and best practices of implementation related to set up, maintenance and quality control of the TMF for drugs, biologics and medical devices.

Areas Covered in the Webinar:

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

Who Will Benefit:

  • Clinical Research Associates (CRAs)
  • Clinical Research Coordinators (CRCs)
  • Clinical Research Administrators
  • Principal Investigators
  • Project Managers
  • Sponsors of INDs
Instructor Profile:
Marina Malikova

Marina Malikova
Executive Director, Boston University School of Medicine

Marina Malikova, Ph.D., MSci, MA, CCRA, RAC - Executive Director, Surgical Translational Research: Operations and Compliance.

Dr. Malikova has over 20 years of experience in the clinical research field. She has managed Phase I – IV studies involving investigational drugs, devices and biologics. 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 also holds a Master’s Degree in Clinical Investigation and Project Management Certification from Boston University.

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 trials and basic biomedical research operations, quality assurance, risk management, safety monitoring, strategic planning, and macro-management of research programs. She provides guidance and oversight to the Project Managers, Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), and laboratory staff. She advises faculty/staff on protocol and informed consent writing; assists with BU IRB applications and submissions; provides oversight for data user agreements, cost coverage analysis and budgets development, contracts and licensing for clinical research; and ensures compliance.

Dr. Malikova has 10 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 since Summer, 2012.

Dr. Malikova is a member of Association for Clinical Research Professionals (ACRP), Drug Information Association (DIA), Regulatory Association Professionals Society (RAPS) and European Society of Radiology (ESR). Currently, she is serving as an Editor for SAGE publishing group and National Institute of Health (NIH) reviewer for grants and clinical trial proposals.

Follow us :
eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada
FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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