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.
Why Should You Attend:
The basis for determining that a drug or device is “Safe and effective” is a series of scientifically sound, appropriately blinded, statistically relevant, and ethically performed process and it controlled by the Investigators.
This Webinar goes over the scientific standards of the drug development process. Starting with the drug discovery process, the role of the dose response relationship, the role of the IND process is discussed. You will learn the regulations to follow in Phase I and the 6 major questions that must be answered in this Phase.
The determination of the first dose in humans is another critical point in the process. Learn the questions each Phase in the development process must answer and how that is managed.. In the end, it is the Safety or risk and the efficacy or benefit ratio, which must be favorable for the process to continue.
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
Note: Use this promocode(117660) for 10% discount.