GlobalCompliancePanel Refer a Friend Program: Any Customer to 3 Referrals "Can Participate 2 Days Seminar for free of Cost.
Overview:
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 industries. This seminar begins with outlining 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 DSUR will be discussed. How to troubleshoot safety events with clinical site principal investigators and how to survive an FDA audit for safety management practices will complete the agenda for this seminar.
Why should you attend?
Since 1970 the regulations for conducting clinical trials has been under the direction of the Food and Drug Administration (FDA), more specifically, FDA's Center for Drug Evaluation and Research (CDER). CDER is the regulatory agency for drug applications, monitoring efficacy, safety and review process during all phases of clinical trials. As defined in its mission statement, "the FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation." The history of clinical research involving humans introduced the Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products in 1995. GCP is the standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trial studies. These guidelines set the minimum quality standards for the conduct of clinical research. Compliance with GCP ensures that the rights, safety and well-being of study participants are protected.
Areas Covered in the Session:
Upon completing this course on the "Best Practices for Safety Reporting in Clinical Trials for Drugs, Biologics and Medical Devices" participants will:
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:
Agenda:
Day 1 Schedule:
Lecture 1:
Introduction to the FDA, Food, Drug and Cosmetic Act - Regulations and Guidance
Lecture 2:
Establishing and Importance of a Clinical Trial Safety Monitoring Plan
Lecture 3:
Outline of Various Safety Management Practices Employed in Clinical Trials
Lecture 4:
The Importance and Training Requirements for Safety Monitors for a Successful Clinical Trial
Lecture 5:
The Process in the Establishment of an Adverse Event Database
Day 2 Schedule:
Lecture 1:
The Procedures and Requirements for Filing and Updating IND Safety Reports
Lecture 2:
Comprehensive Discussion on IDE Safety Reports with Medical Devices
Lecture 3:
Safety Reporting for IND Annual Safety Update and Development Safety Update Report (DSUR)
Lecture 4:
Troubleshooting Safety Events with Site Principle Investigators to Ensure Study Quality
Lecture 5:
How to Prepare for an FDA Audit for Safety Management Practices
19 May 2016 @ 09:00 am
20 May 2016 @ 06:00 pm
Duration: 1 days, 9 hours
WILL BE ANNOUNCED SOON
Raleigh, NC
191 Raleigh
United States
English en