Good Clinical Practice & Preparing for FDA Inspection
Thursday, October 30, 2014 9:00 am to 4:00 pm
Edward S. Harkness Hall Ballroom, 367 Cedar Street
Who Should Attend
This course will benefit those involved in the administration, support and monitoring clinical trials. Employees who work in administration, monitoring, quality, medical care and supporting departments involved with the supervision or oversight of clinical trials will find this session of interest.Learning Objectives
- Identify and define the principles and requirements for GCPs
- Define the basic roles and responsibilities of sponsor, monitor, investigators and FDA as they relate to the quality of clinical trials
- Learn the similarities and differences in GCP for drugs, device and biologic studies
- Understand how GCPs can impact clinical research progress and ensure that GCPs are implemented
- Ensure that your data and supporting documentation are accurate and presentable for inspection
- Comply with informed consent and Human Subject Protection requirements
- Understand what happens during a GCP inspection
Lunch and refreshments will be provided. Registration is available here.
These programs will be led by Michael Hamrell, Ph.D., RAC, an industry professional with over 30 years of experience in regulatory affairs, clinical research and drug development with academia, the FDA, NIH and in industry. He also worked for over 5 years at the FDA and 3 years at the NIH in the Division of AIDS, coordinating the development of drugs, biologics and vaccine products for AIDS, oncology and anti-infectives. Dr. Hamrell has dealt with Regulatory Authorities in over 40 countries and supervised all aspects of product development and approval. Dr. Hamrell has received numerous awards for his research, teaching and professional work and is recognized in Who's Who. He has published numerous papers in pharmacology, regulatory affairs, product development, clinical research, computers and information systems. Dr. Hamrell serves as an Editorial Board member for several leading journals in clinical research and regulatory affairs.