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HUM-MOLGEN
-> Events
-> Courses and Workshops |
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March 09, 2009 |
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The Center for Professional Advancement, 90 Minute Accredited Online Training
April 28, 2009 at 11:00 a.m. - 12:30 p.m. (EST)
Who Should Attend
This course is designed for professionals within the pharmaceutical and biologics industries who are interested in the planning and submissions of INDs. The training will be especially valuable to:
• Regulatory Personnel
• QA Managers
• Directors and VPs
• Representatives of Contract Research Organizations
(CROs)
Description
The FDA procedures for the clinical testing of drugs, potentially leading to the filing of an NDA or ANDA, are evolving rapidly. This 90-minute accredited program examines the steps involved in designing and filing for permission to conduct the clinical tests (the IND) and the FDA issues and concerns in reviewing IND applications.
Module 1: Overview: Clinical Testing Concerns
• QbD
• Post marketing clinical testing
• Phases of Clinical Testing
Module 2: Steps
• Planning the Clinical Testing Process
• Pre-clinical
• IND filing
• Pre-meeting
• Design
• Research
• Investigator's Brochure
• IRB approval
• Format
Module 3: FDA Criteria and Concerns
• Foreign studies
• Design issues
• Safety and IRB review
• Study Size
• Blood/brain barrier
Question and Answer Session
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Organized by:
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The Center for Professional Advancement |
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Invited Speakers:
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Dr. Sandy Weinberg, Independent Consultant to the FDA
Dr. Sandy Weinberg is an Associate Professor of Health Care Management (Regulation) at Clayton State University, part of the Georgia State University System; a retired regulatory professional from the drug, device, and vaccine industries; and a consultant with more than twenty-five years of experience. He is the author of Guidebook to Drug Regulatory Submissions (Wiley, 2008).
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Deadline for Abstracts:
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n/a
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Registration:
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Please click here for registration information.
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E-mail:
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salbers@cfpa.com
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