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Best Practices for Safety Reporting in Clinical Trials for Drugs, Biologics and Medical Devices  

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Seminar Summary:

The mission of the Food and Drug Administration is “Protecting consumers and enhancing public health by maximizing compliance of FDA regulated products and minimizing risk associated with those products.” (see full course description)

 

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Training Course Syllabus:


Best Practices for Safety Reporting in Clinical Trials for Drugs, Biologics and Medical Devices

The mission of the Food and Drug Administration is “Protecting consumers and enhancing public health by maximizing compliance of FDA regulated products and minimizing risk associated with those products.”

The Food and Drug Administration’s Center for Drug Evaluation Research, Center for Biologics Evaluation Research and Center for Devices and Radiological Health are responsible for the approval of drug products, biologics and medical devices in their respective industries.

This seminar will outline the structural role of the FDA and a brief introduction to the Food, Drug and Cosmetic Act (the ACT) and how the FDA uses it to enforce the regulatory requirements during the drug, biologics and medical device approval process.

Additionally, this seminar will highlight safety, which is in the FDA’s mission statement, by guiding participants on how to develop a data safety monitoring plan and when it is important to use a Data Safety Monitoring Board. Additionally, various safety management practices will be discussed and the importance of creating a functional adverse event database.

This seminar will also provide the terminology necessary to establish an adverse event monitoring score and the training requirements for study monitors will be discussed in detail. IND and IDE safety reports, IND annual safety updates and Development Safety Update Report (DSUR) will be discussed. Additionally, the best approach on how to discuss safety events with clinical site principal investigators to correct reporting issues. During the life of a clinical trial, several FDA audits are possible, therefore, an organized plan to have in place on how to survive an FDA audit for safety management practices will complete the agenda for this seminar.


Learning Objectives:
Upon completing this course on the "Best Practices for Safety Reporting in Clinical Trials for Drugs, Biologics and Medical Devices" participants will:

Have a knowledge of the role, structure what the Food and Drug Administration (FDA) regulates
Learn the importance of the Food, Drug and Cosmetic Act (FDCA)
Learn how to setup a data safety monitoring plan and when to use a data safety monitoring board
Learn the various safety management practices employed during clinical studies
Understand the importance of the training requirements of safety monitors (investigators)
Discuss how to create an adverse event database
Learn the submitting process for IND/IDE safety reporting
Understand how to troubleshooting safety events with site principal investigators
Learn how to survive an FDA audit for safety management practices and what Bioresearch Monitoring

Course Outline:
Day One (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

Session 1 (90 Minutes): Introduction to the FDA, Food, Drug and Cosmetic Act – Regulations and Guidance

Role, Structure and Operations of the FDA
Good Clinical Practice (GCP) in Clinical Trials
Regulatory Agencies Involved in Clinical Development of Drug Products
Session 2 (90 Minutes): Establishing and Importance of a Clinical Trial Safety Monitoring Plan

Data Safety Monitoring Plan (DSMP) and Data Safety Monitoring Boards (DSMB)
Who Requires What in Clinical Trials
What is the Best Way to Monitor Your Clinical Trial
Primary List of the Required Contents of DSMP
Session 3 (90 Minutes): Outline of Various Safety Management Practices Employed in Clinical Trials

Data Safety Monitoring Boards (What are they and when are they necessary)
Data Monitoring Committees
Institutional Review Boards (IRB) and Ethical Review Committees
Investigator brochure
Safety Assessment Committees
Session 4 (90 Minutes): The Importance and Training Requirements for Safety Monitors for a Successful Clinical Trial

General Information about a Clinical Monitor
Duties in Specific Phases of Clinical Development
Compliance Training on Good Clinical Practice (GCP), FDA Regulations and Guidelines
Knowledge Specific to Site Study (SOPs, Protocols, Investigational Product)
Site Specific Safety Monitoring
Session 5 (90 Minutes): The Process in the Establishment of an Adverse Event Database

Background
Targeted Data Collection – Recommendations
Circumstances in Which Targeted Data Collection Maybe Appropriate
Method for Target or Selection Collection of Safety Data
When Comprehensive Data Collection is Really Needed
Types of Data That Should be Collected


Day Two (8:30 AM – 4:30 PM)

Session 1 (90 Minutes): The Procedures and Requirements for Filing and Updating IND Safety Reports

General Information about Investigational New Drug (IND) and Investigational Device Exemption (IDE)
Mandatory Safety Reporting (IND – Initial and Follow up Reports)
Monitoring the Safety Database and Submitting Safety Reports
Submitting an IND Study
Safety Reporting for Requirements for BA/BE Studies
Review of Safety Information
Session 2 (90 Minutes): Comprehensive Discussion on IDE Safety Reports with Medical Devices

General Information on an Investigational Device Exemption (IDE)
Mandatory Medical Device Reporting
Responsibilities of Investigator-Sponsor Safety Reports in Clinical Trials
Reporting Requirements for Manufacturers
Reporting Requirements for Investigators
MedSun: Shining a Light on Medical Products Safety
Session 3 (90 Minutes): Safety Reporting for IND Annual Safety Update and Development Safety Update Report (DSUR)

General Principles
Relationship of DSUR to the Periodicity Safety Update Report
Durations of DSUR Submissions
Responsibilities for Preparing and Submitting a DSUR
Guidance on Contents of a DSUR
Significant Findings from Clinical Trials During the Reporting Periods
Session 4 (90 Minutes): Troubleshooting Safety Events with Site Principle Investigators to Ensure Study Quality

Background Information – FDA Guidance
Overview of Clinical Investigator Responsibilities
Supervision of the conduct of the Clinical Investigator
Protecting the Rights, Safety and Welfare of Study Subjects
Reporting Timeframes
Types of Reportable Events
Protocol Deviation – Major and Minor ones.
Session 5 (90 Minutes): How to Prepare for an FDA Audit for Safety Management Practices

Discuss legal obligations of FDA audits and Food Drug and Cosmetic Act
Suggestion as to the steps clinical sites take to prepare for the FDA Inspector
Bioresearch Monitoring or BIMO Inspection
What is Form FDA 482?
FDA inspection procedures
Post-inspection procedures and importance of Form FDA 483

Seminar Summary:

The mission of the Food and Drug Administration is “Protecting consumers and enhancing public health by maximizing compliance of FDA regulated products and minimizing risk associated with those products.” (see full course description)

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