February 16, 2024
Design & Conduct of Clinical Trials: Requirements and Clinical Protocols (two-part series)
Learning Objectives:
- Overview of Drug/Device/Biologic Development Process for FDA Regulated Studies
- Fundamentals of Study Designs: Types of Observational Studies and the Basics of Prospective Design
- IRB Regulations and Process, Informed Consent and the Regulations
- INDs, the IND Process
- Fundamentals of Trials with Medical Devices
March 13th and March 20th
9:00am – 12:00pm EST
Drug Development & FDA Regulations (two-part series)
Learning Objectives:
- FDA’s Role in Drug Development
- Logic of drug development
- Basics of non-clinical drug testing
- Requirements for an IND
- Basics of clinical trial structure and design (Phase 1, 2, 3 clinical)
- Requirements for an NDA
- Post approval responsibilities of sponsor (Phase 4 clinical)
- Fundamentals of GLP, GCP and GMP
April 8th and April 15th
9:00am – 12:00pm EST