CenterWatch Announces — Early Bird Pricing Ends on Mar. 1 for ICH GCP E6 R2: Meeting CRO-Vendor Oversight Requirements Conference, March 27, 2019

SOURCE: PRWeb Press Release


ICH GCP E6 R2 changed the CRO-vendor oversight requirements. Do the programs pass muster?


ICH GCP E6 R2
Meeting CRO-Vendor Oversight Requirements
**An Interactive Workshop Presented by CenterWatch and Wool Consulting Group**
March 27-28, 2019
Raleigh, NC

For clinical trials, it’s a whole new game.

The ICH GCP E6 R2 guidelines now require sponsors/CROs to implement a CRO-vendor oversight framework… procedures… methods… oversight plans… and equipping staff to ensure compliance, meet regulatory expectations and maintain a constant state of control over the trial, CRO-vendors and inspection readiness.

Whether the organization is virtual, small, medium or large, the requirements are the same.

FDAnews has teamed up with Wool Consulting Group to present a two-day hands-on workshop aimed at helping one understand and comply with new ICH GCP E6 R2 rules. Course instructor — Liz Wool, CCRA, CID, CMT — will provide methods and solutions for effective implementation of the rules. Over the course of two days she’ll:

  • Explain the regulatory authority perspective for CRO and vendors in relation to ICH GCP E6 R2 requirements
  • Identify the CRO-vendors requiring oversight
  • Determine the CRO-vendor practices for oversight of their sub-contractors to meet the requirements and the organization’s expectations
  • Examine effective and compliant CRO-vendor oversight methods
  • Assess CRO-vendor governance-leading practices to implement at the organization
  • Formulate a CRO-vendor oversight plan template for the organization that can be used by multiple departments
  • Examine the common pitfalls to effective implementation and leading practices to mitigate the risks of these pitfalls from occurring in the organization
  • Describe regulatory authority inspection findings regarding CRO-vendor oversight

Through presentations, discussion, class activities and handouts attendees will learn how to implement ICH GCP E6 R2 requirements in the organization.
Early bird pricing ends on Friday, Mar. 1

Meet Your Presenter

Liz Wool, CCRA, CID, CMT has 29 years clinical research experience in clinical operations, compliance, CRO-vendor oversight and training, She is a certified CRA (ACRP), instructional designer and master trainer and a member of the National Speakers Association. She is a recognized industry expert on CRO-vendor oversight/management who has presented on this topic in both the United States and the European Union since 2010 for both nonprofit professional associations (DIA) and industry conferences.

Who Will Benefit

  • CRO Professionals
  • Clinical Research Managers/Associates
  • Regulatory Affairs Managers/Associates
  • Pharmacovigilance Managers/Associates
  • Clinical Operations Managers/Associates
  • QA Managers/Associates
  • QC team members
  • Quality Unit Managers And Leaders
  • Quality Auditors
  • Procurement Specialists
  • Business Development Personnel
  • Technical Services

Webinar Details:

ICH GCP E6 R2
Meeting CRO-Vendor Oversight Requirements
**An interactive workshop presented by CenterWatch and Wool Consulting Group**
March 27-28, 2019
Raleigh, NC
http://store.centerwatch.com/p-581-ich-gcp-e6-r2-meeting-cro-vendor-oversight-requirements.aspx

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