Compliance with the New ICH GCP Revision 2 Addendum
April 1, 2019 - Fremont CA USNetzealous LLC DBA - Compliance4All
compliance4all14@gmail.com
Phone:18004479407
Fax:302-288-6884
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: compliance4all14@gmail.com