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SPECIALITES MEDICALES ...

FDA regulations and the ICH GCP recommendations

Du Mardi 06 Mars 2018 au Mardi 06 Mars 2018 à CA
A partir de: 10:00
Secteurs concernés: Santé publique -
DESCRIPTION
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

PUBLIC, SECTEURS, ACCREDITATION
Accréditations : 0
Public concerné: Tous
Audience: Internationnale
Visiteurs/Participants: 50
Conférenciers: 1
Exposants: n.r
Type d'événement: Conférences en ligne
Secteur principal: SANTE PUBLIQUE
Secteurs concernés: Santé publique -
ORGANISATEUR / ANNONCEUR

COMPLIANCE4ALL
161 Mission Falls Lane, Suite 216,
94539 Fremont
UNITED STATES

COMMENT
REFERENCE
Congrès, formations ou conférences médicales REF #28-7825
FDA regulations and the ICH GCP recommendations
Publié sur congres-medical.com le : 2018-02-01 10:57:56
Congrès, formations ou conférences médicales en SANTE PUBLIQUE
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