Login Register
Life Science Training Institute
  • Courses
    • All Courses
    • Upcoming Live Courses
    • By Category
      • Clinical Trials
      • Manufacturing
      • Med Device
      • Regulatory
      • R&D
      • Leadership & Training
    • Training Voucher Packs
    • Meet the Instructors
  • Blog & Resources
  • About Us
    • About LSTI
    • Onsite/Custom Training
      • Custom Training
      • Custom Training Delivery Types
      • CRA Academy
    • FAQs
    • Contact Us
    • Email Communications
  • View Cart
  • Join Our Mailing List
  • Courses
    • All Courses
    • Upcoming Live Courses
    • By Category
      • Clinical Trials
      • Manufacturing
      • Med Device
      • Regulatory
      • R&D
      • Leadership & Training
    • Training Voucher Packs
    • Meet the Instructors
  • Blog & Resources
  • About Us
    • About LSTI
    • Onsite/Custom Training
      • Custom Training
      • Custom Training Delivery Types
      • CRA Academy
    • FAQs
    • Contact Us
    • Email Communications
  • View Cart
  • Join Our Mailing List
HomeClinical TrialsCRO Oversight Post ICH GCP E6 (R2) Addendum

CRO Oversight Post ICH GCP E6 (R2) Addendum

Teachers
Sandra “SAM” Sather
Category:
Clinical Trials/ On Demand Courses/ Regulatory & Compliance/
Clear
Duration: 60-Minutes
On-Demand
Includes handouts
  • Description
  • Who Should Attend
  • What To Expect

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

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

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.

About Instructors

Sandra “SAM” Sather
Industry-leading consultant whose mission is to promote clinical quality systems for Sponsors/CROs and Investigators/Research Institutions.

There are no reviews yet.

Be the first to review “CRO Oversight Post ICH GCP E6 (R2) Addendum” Cancel reply

Clear
Duration: 60-Minutes
On-Demand
Includes handouts

CATEGORIES

  • Sales & Marketing (1)
  • Clinical Trials (99)
  • Manufacturing (88)
  • Med Device (55)
  • Quality (39)
  • Regulatory & Compliance (197)
  • Research & Development (70)
  • Leadership & Training (36)
  • IT & Data (31)
  • Upcoming Live Courses (8)
  • On Demand Courses (220)
  • Introductory Courses (19)
  • Special Packages (5)

TOPICS

Cleaning Validation Cleanroom Clinical Trials Cloud CMOs Computer Systems CRAs CROs Data Integrity Device eCTD EHRs EMA Equipment Facilities FDA GCP GDP GLP GMP HIPAA Human Error ICH Informed Consent Inspections Instructional Design Management manufacturing Marketing MDR microbial control Process Validation Project Management Quality Quality by Design Quality Risk Management Remote Monitoring Risk Risk-Based Monitoring Root Cause Analysis Site Monitoring SOPs Training Trial Master File Upcoming Courses

Your Courses

Upcoming Live Courses

  • Clinical Research Project Management - 7 Breakthrough Behaviors For Success
  • Essentials of Disinfectant Efficacy Testing – Ensuring Microbial Control
  • The MHRA Data Integrity Guidance Clarified: What it Means for Industry & Patients
  • Implementing a Robust Change Control Program – Key Elements for Process and Documentation Compliance
  • Responding to Clinical Observations: Developing Robust Audit & Inspection CAPAs
  • CAPA and Root Cause Analysis: Essentials Post ICH GCP E6 (R2) Addendum
  • Medical Device Recalls – Keys To Implementing A Successful Approach

Contact

  • 101 Gibraltar Road, Suite 100. Horsham, PA 19044
  • 215-675-1800 (option 3)
  • info@lifesciencetraininginstitute.com
Footer logo
Copyright © 1996-2017 VertMarkets, Inc. All Rights Reserved.
  • home
  • About LSTI
  • courses
  • Enterprise
  • Privacy
  • Terms
Search
We use cookies to ensure that we give you the best experience on our website. If you continue to use this site we will assume that you are happy with it.Ok