FDA regulations and the ICH GCP recommendations

Overview:

• It will be important to see what the FDA regulations and the ICH GCP
• recommendations are in this regard. The key is that the PI and all
• clinical staff know and follow the research plan (Protocol) exactly as it
• is written. To do this is ethical research. To not follow the protocol and
• document study conduct carelessly is folly.

Why should you Attend:

• All CRO's, Sites, and Sponsors of Clinical Research involved in the
• drug and device development process have an interest in being
• prepared for the audit process. Attending this Webinar is a good step
• toward learning the FDA processes and why the Sponsor's / CRO's
• Monitors are so important.

Areas Covered in the Session:

• What does the FDA look at when Auditing/Inspecting a study?
• The Sponsor's responsibility in monitoring study conduct
• Components of a sponsor monitoring system beyond SOPs
• The nature of adequate oversight of all staff and non-staff
• The importance of Protocol knowledge in preventing errors
• How do sites prepare for an audit / inspection 

Who Will Benefit:

• This Webinar will provide invaluable assistance to all personnel in the
• Pharmaceutical, Biotechnology, and CRO industry Conducting Clinical
• Trials including:
• Senior Management
• Project Managers
• CRA Managers
• QA/Compliance Persons 

Speaker Profile:
Charles H. Pierce MD, PhD, FCP, CPI is a consultant in the Clinical
Research / Drug-Device Development arena specializing in bringing
the message 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.

Event Fee: One Dial-in One Attendee Price: US$150.00

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]

Others Details

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