ICH GCP E6 R (3) Client Webinar Series

 Webinar Series Description

Each month, Liz  covers critical topics related to ICH GCP E6 (R3). These webinars are designed to provide the insights and context for the changes,  an overview of the changes and impact to your clinical trials, recommended next steps, and Q & A. 

These are not ‘boring’,  ‘talking head’ virtual trainings! 

Liz is an expert biotech and pharma trainer, a certified instructional designer and master trainer. As a master virtual trainer, Liz develops and delivers expert content that is thought provoking, engaging, interactive and solution focused trainings.

Liz uses advanced technology tools and whiteboards for a training ‘experience’ that mirrors in-person trainings!

Contact Liz today: liz@woolcg.com

Training Topics

Overview of Changes - and the HOT Topics for Compliance!

Agenda

1.  Introduction and Context for Changes

2.  Where do I find all of the ‘requirements’ in this new Guideline?  Hint- NOT all are in ONE place!

3.  Overview of ICH GCP E6 (R3) Changes

4.  HOT Topics for Compliance

5.  Implications for Clinical Trials

6.  Don't forget ICH E8 R(1)  

7.   Next Steps

8.   Q&A Session

Vendor (Service Provider) Requirements Changes

Agenda:

1.  Introduction and Context for Changes

2.  Overview of Changes for Vendor (Service Provider) & Oversight 

3.  Implications for Clinical Trials

4.  Next Steps

5.   Q&A Session

Sponsor Changes & **NEW** Sponsor Oversight

Agenda

1.  Introduction and Context for Changes

2.  Overview of Changes to Sponsor Responsibilities

3.  **NEW Section** Sponsor Oversight

4.  Implications for Clinical Trials

5.  Next Steps

6.   Q&A Session

Risk Based Quality Management/Clinical Trial Risk Management (Quality Management) Changes

Agenda

1.  Introduction and Context for Changes

2.  Overview of Changes to Risk Management

3.  QTL requirements

4.  Implications for Clinical Trials

5.  Next Steps

6.   Q&A Session

Investigator-Site Responsibilities Changes 

Agenda

1.  Introduction and Context for Changes

2.  Overview of Changes to Investigator-Site Responsibilities

3.  Implications for Clinical Trials

4.  Next Steps

5.   Q&A Session

**NEW Data Governance &**NEW Detailed Computerized Systems Changes
Agenda

1.  Introduction and Context for Changes

2.  Overview of Computerized Systems Requirements 

3.  Overview of Data Governance Requirements

4.  Implications for Clinical Trials

5.  Next Steps

6.   Q&A Session

Trial Master File/Essential Documents 

Agenda

1.  Introduction and Context for Changes

2.  Overview of Changes Essential Documents & Implications for the Trial Master File (TMF)

1.  Implications for Clinical Trials

2.  Next Steps

3.   Q&A Session

IRB/IEC Changes

Agenda

3.  Introduction and Context for Changes

4.  Overview of Changes for the IRB/IEC 

4.  Implications for Clinical Trials

5.  Next Steps

6.   Q&A Session