Learn the scientific standards of drug development process, the regulations to follow in Phase I and how to manage each phase of drug development process.
Areas Covered in the Seminar: - What is the goal of Preclinical drug development.
- What do we learn from the Dose-Response relationship.
- What are the hallmarks of a good study protocol.
- Who are the main players in the development of safe medicines.
- How do you chose the starting does for the first-in-man studies.
- What questions are answered in Phase I Clinical Research.
- How is the first time in patients (Phase IIa) handled.
- What is the main goal of Phase III studies.
- What are the main methodological Issues encountered in Clinical Research.
Who Will Benefit:This webinar will provide invaluable assistance to investigators and their staff in the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (Drug or device) research involving human subjects. Those benefiting the most would be:
- Principal Investigators / Sub-investigators.
- Clinical Research Scientists (PKs, Biostatisticians).
- Safety Nurses.
- Clinical Research Associates (CRAs) and Coordinators (CRCs).
- QA / QC auditors and staff.
- Clinical Research Data managers
