This interactive course provides an in-depth introduction to the methodology of design and implementation of controlled clinical trials and general process to develop new drugs. We will review the regulatory context, standard methodology, ethical and practical issues as well as industry best practice. This program provides a unique opportunity for the participants who are looking to initiate a career in clinical trials or individuals who have recently started such a position and need a basic training to be more proficient in their function.
Day 1
- Overview of the Drug Development Process
- Phases of a Clinical Trial- Phase I, II, III, IV
- Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) guidelines
- The Clinical Research Team
- Protocol Design, Randomization, Blinding of Trials
- Selection of Investigators and Sites
Day 2
- Institutional Review Board/Protection of Human Subjects
- Clinical Trial Documents- Case Report Forms, Informed Consent, etc.
- Project Management and Clinical Trials
- Investigational Product
- Adverse Event and Safety Reporting
- Monitoring Clinical Trials
Instructors Info
Bruno Gagnon, B.Pharm., M.Sc.
Bruno Gagnon is a Senior Consultant with the Biologics Consulting Group, Inc. He creates powerful partnerships that enable his clients to optimize the way they execute their clinical trials. Until August of 2006, he was a functional leader at Chiron Corporation (now Novartis) in BioPharmaceutical Development.
Bruno has 14 years of experience in Clinical Operations. He held positions of increasing responsibilities in the Big Pharma, CRO and Biotech sectors. His teaching experience includes San Francisco State University, Barnett International professional seminars, University of San Diego, UCSD Extension. He is also frequently invited as a speaker for different pharmaceutical industry conferences.
Neerja Sethi, Ph.D.
Neerja Sethi is the Founder and CEO of Astragen LLC, a company focused on Genomics and Bio-IT solutions for Drug Development and Clinical Trials. Neerja Sethi is also the co-founder of a Stem Cells Therapeutics and Pharmacogenomics startup company-Cellastra Inc. She has over 12 years experience in molecular biotechnology research and over 7 years experience in technology development, business development, developing global alliances, consultancy, as a faculty and clinical trials training. She has provided Clinical Trials training for SFSU, CEL program and for IES, Inc.
Neerja Sethi has developed successful research programs in the Departments of Medicine and Stomatology at University of California San Francisco Medical Center and at the Swiss Tropical Institute, Basel, Switzerland. Her career has been focused on development of therapeutics in the fields of Oncology and Virology and on applying Functional Genomics in different aspects of therapeutic development. She has a number of awards, grants and peer-reviewed publications to her credit.
