Market Overview

CenterWatch Announces -- ICH GCP E6 R2: Meeting CRO-Vendor Oversight Requirements Conference, March 27, 2019


FALLS CHURCH, Va., Jan. 28, 2019 /PRNewswire-PRWeb/ -- 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

Early Bird Savings: Register by March 1 and Save $200

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.

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

Early Bird Pricing: $1,597.00 (available until Mar. 1, 2019)
Regular Pricing: $1,797 (after Mar. 1, 2019)
Significant team discounts are available.

Easy Ways to Register:
By phone: 888-838-5578 or 703-538-7600

About CenterWatch:
Founded in 1994, CenterWatch is a trusted source and global destination for clinical trials information for both professionals and patients. CenterWatch provides proprietary data and information analysis on clinical trials through a variety of newsletters, books, databases, and information services used by pharmaceutical and biotechnology companies, CROs, SMOs, and investigative sites involved in the management and conduct of clinical trials. As a pioneer in publishing clinical trials information, CenterWatch was the first Internet site to publish detailed information about active clinical trials that could be accessed by patients and their advocates.


SOURCE CenterWatch

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