CRO Oversight Post ICH GCP E6 (R2) Addendum

$279.00$2,550.00

With the release of ICH E6 R2 GCP update, risk management practices are now expected to be incorporated into the selection and oversight of CROs and other vendors. Join us for this 60- minute presentation and be taken through a clinical trial case scenario applying a sponsor oversight plan.

Description

COURSE DESCRIPTION

OVERVIEW

The ICH E6 GCP update expects that sponsor will provide adequate oversight of a Contract Research Organizations (CROs) when sponsor responsibilities have been transferred for the conduct of a clinical trial. The updated expectations from ICH E6 Addendum come in response to many negative global audit findings related to a lack of vendor oversight.

Risk management practices are now expected to be incorporated into the selection and oversight of CROs and other vendors. Establishing effective communication plans for risk analysis and action plan responsibilities is of paramount importance in preventing problems and ensuring inspection readiness.

Typically, defining roles, skill-sets, and setting implementation strategy is critical for vendor oversight. It is essential that sponsors include support for formally including a risk-based and performance management approach to vendor oversight, which will improve the outcomes of the trials, ultimately lending to cost savings.

LEARNING OBJECTIVES

Join us for this 90- minute presentation and be taken through a clinical trial case scenario applying a sponsor oversight plan. Major differences between past best practices and the new guideline will be discussed, along with common pitfalls to avoid.

By joining our interactive session, you will:

  • Identify the risk-based study management approaches to CRO oversight.
  • Recognize areas to assess for gaps in current approaches to CRO selection and oversight related to quality risk management.
  • Work through a case scenario to learn to identify key approaches to planning and preparing to outsource.

WHO SHOULD ATTEND

This course will be valuable to anyone working in clinical trials.  Specifically, this course will be of greatest benefit to those working in clinical operations, clinical quality, and monitoring roles.  Additionally, this session will be of value to sponsors responsible for CRO oversight plus anyone who is affected by the quality of trial performance.

WHAT TO EXPECT

HOW TO PARTICIPATE

This webinar is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.

THE TRAINING PLATFORM

Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.

USER AGREEMENT

Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.

Is this course right for me? We’d be happy to help you select the right training course to meet your needs.
Give us a call at 215-675-1800 and use Option 3 (9am – 5pm EST, M-F) for assistance.

Additional information

Format

Recorded Only

Participants

Single Participant, 5 Participant Value Package, 10 Participant Value Package

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