Why Should You Attend:
The first time an Investigational Medical Product (IMP) is given to human subjects great care must be taken by all concerned, especially the Principal Investigator, in choosing the appropriate starting dose and thence the right dose escalation to accurately determine the pharmacokinetics as well as the safety of the IMP being studied.
Phase 1 and 2a of the Drug development process are conducted in very special units that in addition to subject amenity areas have immediate access to an EMS area, access to a GLP laboratory and a functioning EDS. In these CPU/CRU’s numerous studies are carried out on normal human volunteers (with notable exceptions) to define the pharmacodynamics and pharmacodynamics in a variety of situations So the dose range and safety is known prior to studies in patients in Phases 2b and 3.
The topics covered in this webinar will provide invaluable assistance to investigators and their staff in regulatory or legal responsibilities and also highlight the ethical considerations in drug or device research involving human subjects.
Areas Covered in the Webinar:
Who Will Benefit:
The following professionals from pharma and biotech companies, contract research organizations, research sites, hospitals and university research groups will benefit from this training:
Charles H. Pierce, MD, PhD, FCP, CPI Has 27+ years experience in the Clinical Research field. He now brings the message (via webinars, lectures and seminars) of Risk Management through knowledge of GCP Regulations and Investigator Responsibility to the entire investigative team to help them understand the regulations as well as the ethics of research involving human subjects. He has been involved in Investigator and staff GCP training, and medical monitoring in both drug and device studies.
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