Course Description:

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

Seminar Fee Includes:

AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Who will Benefit

This course is designed for people tasked with developing drug products, biologics and medical devices; and responsible for overseeing a company's clinical development program and regulatory strategies. This includes individuals responsible for overseeing regulatory affairs, developing strategies for establishing data safety monitoring plans, establishing adverse event databases, submitting timely safety reports to comply with regulatory compliance and those tasked with ensuring corporate compliance. Among others, this includes:

  • Quality managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Medical device professionals
  • Biotechnology and pharmaceutical professionals
  • Clinical Investigators
  • Study Monitors
  • Quality auditors
  • Data analysis specialist
  • Document control specialists
  • Record retention specialists
  • Medical affairs
  • Marketing Staff

Course Outline:

Day One (8:30 AM – 4:30 PM) Day Two (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

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

Meet Your Instructor

Harold Thibodeaux
Research Investigator

Harold Thibodeaux is a medical research scientist with in vivo pharmacological experiences in both academia and biopharmaceutical industry. During his prestigious career the focus of Mr. Thibodeaux’s research efforts has been on the efficacy of cardiovascular drugs most notably Hypertension, Myocardial Infarction, Focal Ischemia (Stroke), Beyond Advair Pulmonary Research and topical antibiotics. Optimal therapeutic benefits were the goal in all of these projects but cardiovascular safety to provide safer medicines to patients was a priority. Mr. Thibodeaux transitioned into the pharmaceutical industry when he joined the Cardiovascular Department of Genentech in 1990, as a technical lead with the Second Generation TPA Project Team. Mr. Thibodeaux is a graduate from the College of Charleston with a Bachelor of Science Degree in biology and is a member of The Safety Pharmacology Society.

During his prestigious career, Harold Thibodeaux’s ambition and innovation resulted in the successful clinical development of several novel drugs. As a young scientist with Genentech, his contributions to the Second Generation TPA Project were rewarded with the FDA approval of a thrombolytic drug (TNK-TPA or Tenectaplase) that was indicated for Acute Myocardial Infarction. Another notable achievement with the same project team was the approval of Activase Alterplase for Acute Ischemic Stroke Treatment.

As a scientist at Theravance, his innovative models of cardiovascular safety were instrumental in the formation of a Theravance/GlaxoSmithKline Partnership and the development of two clinical candidates for Chronic Obstructive Pulmonary Disease (COPD). Both drugs, BREO Ellipta and ANORO Ellipta, were approved by the FDA and are currently providing therapeutic benefits with patients with COPD.

In his role as an investigative scientist with Stiefel, a GlaxoSmithKline Company, Mr. Thibodeaux explored new medical research paths and using his many years of experience in the industry to support project efforts for the reformulations of topical antibiotics, development of models to study acne and writing protocols psoriasis.

During his years of academia and pharmaceutical industry provided an opportunity to authored 23 published articles and discussed his work with poster presentation at major scientific meetings. Harold is proud to have been a medical researcher in both academia and the biopharmaceutical industry and continues to support projects that lead to strategic partnerships that will develop novel drug pipelines for unmet medical needs and present webinars and seminars on drug development to assist pharmaceutical companies achieve their goals.

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Local Attractions

The Philadelphia Museum of Art sits majestically on a rise at the end of the Benjamin Franklin Parkway. The vast collections of this temple of art make it the third-largest art museum in the country, and an absolute must-see on the city's cultural circuit.

Among its impressive holdings in Renaissance, American, Impressionist and Modern art, some standouts include a great Rogier van der Weyden altarpiece, a large Bathers by Cezanne, a room devoted to Philadelphia's own Thomas Eakins, and Marcel Duchamp's notorious mixed-media Bride Stripped Bare by her Bachelors (The Large Glass), exactly as the dada master installed it.

With more than 3,600 acres of rolling hills and well-worn trails, Valley Forge is now a magnet for runners, bicyclists and picnickers as well as history buffs.

The vast expanse of open space links the Schuylkill River Trail to the Horse Shoe Trail, turning the park into a major hub in a 75-mile system linking Philadelphia to the Appalachian Trail.

The Liberty Bell has a new home, and it is as powerful and dramatic as the Bell itself. Throughout the expansive, light-filled Center, larger-than-life historic documents and graphic images explore the facts and the myths surrounding the Bell.

The 160,000-square-foot National Constitution Center explores and explains this amazing document through high-tech exhibits, artifacts, and interactive displays. The Kimmel Theater, a 350-seat star-shaped theater, features “Freedom Rising,” a multimedia production combining film, a live actor and video projection on a 360° screen to tell the stirring story of “We the people.”

An innovator in designing hands-on exhibits before “interactive” became a buzzword, The Franklin Institute is as clever as its namesake. Its eminently touchable attractions explore science in disciplines ranging from sports to space.

Highlights include The Sports Challenge, which uses virtual-reality technology to illustrate the physics of sports; The Train Factory's climb-aboard steam engine; Space Command's simulated earth-orbit research station; a fully equipped weather station; and exhibits on electricity.

The Barnes Foundation was created in 1922, a school originating with Barnes’ educational experimentation in his Argyrol (pharmaceutical) factory. Barnes and The Foundation’s first director of education, John Dewey, were interested in fostering cognitive development through new approaches to education, and in heightening critical-thinking and problem-solving skills through the study of art. Barnes, like Dewey, was actively engaged in development of an intellectual framework and educational philosophies and practices with many of the best artists and thinkers of his day.

One of Philadelphia’s most famous pieces of public art is a bigger-than-life boxer… literally. Originally created for Rocky III, the sculpture is now a real-life monument to a celluloid hero. The fictional Rocky Balboa of Sylvester Stallone’s Rocky movies was immortalized in bronze in 1980. After filming for the movie completed, Stallone donated the statue to the City of Philadelphia.

Franklin Square, one of Philadelphia’s five original public squares laid out by William Penn in his original plan for the city, has undergone a dramatic renovation. The park now boasts several family-friendly attractions, including a miniature golf course, classic carousel, burger joint, storytelling bench, picnic area and more.

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