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      Compliance with the New ICH GCP Revision 2 Addendum in Fremont

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      April 1, 2019

      Monday  10:00 AM - 11:00 AM

      2450 Stevenson Boulevard
      Fremont, California 94538

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      Compliance with the New ICH GCP Revision 2 Addendum

      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

      Cost: One Dial-in One Attendee Price: $150.00

      Categories: Conferences & Tradeshows | Education | Health & Wellness

      Event details may change at any time, always check with the event organizer when planning to attend this event or purchase tickets.