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The Role of the Regulatory Affairs Professional
(1 or 1.5 days)
Instructor: Damaris Degraft-Johnson, Consultant, RPh MSc. Med. Chem.
Co-Trainer: Joan Fletcher
General Description:
The participants of this course will receive an in depth look at the role of the regulatory affairs professional in the arena of drug development.
Goals:
• Learn the role of the professional in product development
• Learn the role of the professional in registration
• Learn the role of the professional in life-cycle management
• Learn the personal liability for the RA professional and who is at risk
Method of Training:
• Lecture
• Student exercise
• Q&A
Target Audience:
• Scientists and regulatory affairs professionals with responsibilities in product development, manufacturing, and quality control
• Regulatory affairs professionals associated with pharmaceutical R&D institutes and regulatory agencies
Disclosure Policy:
© 2004. All rights jointly reserved by CPS/DJA.
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