Before the celebration of a successful clinical development of a novel therapeutic molecule, the teams face several years of challenges with the drug development process.
In early drug development when just an idea has been placed on a path to clinical development the project team identifies the possible risk associated with that class of drug. This webinar has been designed to discuss the terminology and definitions of adverse events and to compare the difference between an event and an adverse reaction. Anticipated and unanticipated adverse events will be discussed with examples provided to clarify the differences. By understanding the terminology involved a more accurate analysis of the safety data can be achieved. Significance of the analysis will determine whether the data should be reported to the sponsor (Pharmaceutical company) and/or the FDA. The webinar will discuss the role of the principal investigator in the reporting process during the clinical trials.
This webinar presentation will discuss the required post-marketing monitoring stage, which is typically named Phase 4 of the drug development process. This part of the webinar will cover the FDA's Post-Approval Risk Assessment System and the reason for its use. Finally, the webinar will present and discuss the FDA's Med Watch Voluntary System, how physicians and consumers have the opportunity to play a critical role in the drug development system.
Why should you Attend: The ultimate goal of the clinical development process is to successfully conduct the appropriate clinical trials that will be on a path of final approval by the Food and Drug Administration (FDA). In effort to avoid clinical failure, an important aspect of the process is to understand drug safety both during the investigational stage (clinical trials) and the marketing phase (post-approval). In the investigational stage the Institutional Review Board (IRB) continues to review the study at appropriate intervals defined by the risk of the study “to assure the protection of the rights and welfare of human subjects”. To comply with the regulations and guidelines for reporting adverse events, principal investigators and pharmaceutical sponsors have knowledge of the terminology to determine whether an event is an adverse reaction, adverse event, unanticipated adverse event and/or an unanticipated problem. Guidelines encourage the analysis of the adverse events monitored to determine the statistical significance prior to reporting to the IRB.
Once a drug receives approval by the FDA, the post-marketing monitoring stage begins. This stage is named Phase 4 and requires the sponsor (typically the manufacturer) submit periodic safety updates to the FDA. The reason for using the FDA's Post-Approval Risk Assessment System is that it is not possible to predict the all of a drug effects during the clinical trials therefore monitoring safety issues after drugs get on the market is critical. The role of the FDA's Post-marketing safety system is to detect serious unexpected adverse events and take definitive action when needed.
The FDA's MedWatch voluntary system was introduced to provide physicians and consumers to the opportunity to submit reports of adverse events. When new risk is reported the FDA acts by changing the labeling, informing the public with letters and in some rare cases removed from the market.
Areas Covered in the Session:
Drug Safety During Clinical Development and Post-Marketing
Adverse Event Identification
Adverse Reporting Requirements
ICH Roles in Drug Safety Process
Role of the IRB in the Safety Document Review
Compare Adverse Reporting in United States and Europe
Post-Approval Risk Assessment System
Voluntary Physician and Consumer Reporting System - MedWatch
Who Will Benefit:
Regulatory affairs office
Medical affairs office
Quality Assurance and Quality Control
Clinical Research Organizations
Regulatory Compliance Associates and Managers
Statistical and Data Analysis Managers
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.