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Boston Professional Events List
Live webinar Good Clinical Practices: Regulations and Compliance
Link to Website
Ticket Price: $179 One Dial-in One Attendee| $279 One Dial In - Max 10 attendees | $399 Multiple locations up to 5 dial in | $249 Recorded | $299 CD/DVD|
Adherence to the principles of good clinical practices (GCPs), including adequate human subject protection (HSP) is universally recognized as a critical requirement to the conduct of research involving human subjects. Many countries have adopted GCP principles as laws and/or regulations. The Food and Drug Administration’s (FDA’s) regulations for the conduct of clinical trials, which have been in effect since the 1970s, address both GCP and HSP and are required for any company that conducts trials on human subjects
Why should you attend
At its core, Good Clinical Practice (GCP) is a set of broad regulatory requirements, standards, and recommendations that apply to thousands of highly specific tasks, processes, and roles in the conduct of clinical research. It is important to remember that much of the practical standards used in the conduct of clinical trials are "best practices" derived from regulations, guidance, and industry standards and practices and not all found in black and white in the regulations.
• Define Good Clinical Practice (GCP)
• Outline the goals of GCP
• Provide a historical perspective on GCP
• Outline FDA regulations relating to GCP in medical device research
• How to implement GCP
• How FDA Inspects for GCP
• How FDA GCP relates to international regulations
Who will Benefit
• Regulatory Affairs
• Quality Assurance
• Regulatory Authority Inspectors
• Clinical Safety Personnel
• Clinical Data Management Personnel
• IT personnel working on Clinical Systems
Angela Bazigos.CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers. Positions include Chief Compliance Officer at Morf Media.
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