Compliance with the New ICH GCP Revision 2 Addendum

Overview:
This will enable you to meet the new international GCP standard to ensure regulatory compliance and the acceptance of clinical trial data by the regulatory authorities internationally.

Why should you Attend:
With the new ICH GCP E6 Revision 2 Addendum now finalised the changes should have been implemented for organisations running clinical trials.

Areas Covered in the Session:
Review the new requirements for Sponsor and Investigator Oversight
Understand requirements for CROs, quality systems
Explore risk based approaches for clinical trials
Consider changes for the TMF
Best practice for Clinical QMS

Who Will Benefit:
Global Clinical Safety and Pharmacovigilance Officers
Compliance Staff
Clinical Quality Auditors
Quality Assurance Personnel
Document management

Speaker Profile:
Dr. Laura Brown , PhD, MBA, Diploma Clinical Sciences, is an independent QA and training consultant in the pharmaceutical industry. She is a managing director with LB Training and Development Ltd., course director for the M.Sc. in Clinical Research, School of Pharmacy at the University of Cardiff, and course director for M.Sc.

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

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