Get trained on the requirements of trial master file for pharmaceutical products, biotech, a medical device or a diagnostic product

1. Essentials of the Trial Master File for Pharmaceutical, Biotech, Medical Device
and Diagnostics Industries and Paper vs. Electronic TMFs - Which is Correct for
My Program
This training on clinical compliance will focus on the requirements of trial master file (TMF) for
pharmaceutical product, biotech, a medical device or a diagnostic product. Attendees will learn
the best practices to ensure that the TMF is ready for inspection by the regulatory authority.
Why Should You Attend:
The large majority of NDA and many 510(k) submissions are not submitted to the regulatory
agencies in a timely manner due to issues with the Trial Master File (TMF). While clinical
operations usually leads TMF efforts, staff throughout the company have res ponsibilities as part
of the TMF, and the TMF cannot be closed until all members complete their required sections.
Members of Data Management, Biostatistics, Medical Writing, CMC, Legal Affairs, Regulatory
Affairs, Quality Assurance and others have documents or sections that they must complete and
should be well aware of those requirements and formats of those documents before the study
starts. These requirements are in effect whether it is a large, global Phase 3 study, a 10 subject
Phase 1 study or a laboratory-based diagnostics study. It is this TMF which will get reviewed
upon your submission and often by different reviewers not previously involved with your
program when the studies occurred. It is also this TMF which is open for regulatory agency
audits so it is important that you standardize what is and what is not in the TMF and the
method that is used to collect the documentation.
This webinar will focus on the required parts and order of the TMF based on the type of
investigational product, whether it is a pharmaceutical product, a medical device, or a
diagnostic product. Roles and responsibilities of each study team member regarding TMF
documentation requirements will also be discussed.
Areas Covered in the Webinar:
The required parts and order of the TMF, specific to each industry
How to perform continual quality assurance of the TMF to ensure early TMF closure
Specific roles and responsibilities of each study team member regarding TMF
documentation requirements
TMF storage and security requirements
How to choose a TMF format – paper vs electronic or digital
Common pitfalls in TMF documentation
What Regulatory Agencies are looking for during TMF review

2. Who Will Benefit:
This webinar will provide valuable assistance to all personnel in:
Any role within the pharmaceutical, medical device or diagnostics clinical development
portion of a company who have responsibility in ensuring success of a clinical trial
Clinical Operations personnel
Data Management personnel
C-level and VP-level personnel
Regulatory Affairs
Quality Assurance
Legal Affairs
Biostatistics
For More details visit us at:
http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=703210?
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