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Resources

eLearning R2 Awareness Training

The fastest and most cost effective way to understand what ICH E6 (R2) is, why it is so important, and what it means to your organization. This 90-minute course is available as a self-serve eLearning package, or an instructor led webinar. The course is targeted at individuals within Sponsor organizations and CROs that are involved in the design, conduct…

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Webinar: ICH E6 (R2): Training and Certification

May 3, 9:30am – 11:00am ET This webinar is a comprehensive review of the changes included in revision 2 of the ICH E6 guidance. It is designed for anyone who is looking for a broad understanding of the changes, or is in the process of adopting the changes in readiness for compliance. Delivered by our in house expert, Tammy…

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Webinar: ICH E6 (R2): A Practical Guide to Risk Assessment, Evaluation and Implementing Risk Controls

April 10, 9:00am – 11:30am ET Protocol Risk Assessment is the genesis of the new Quality Management section (5) of ICH E6 (R2) and core to the principles of quality by design (QBD). It drives much of the downstream quality planning and management activity during the course of a clinical trial and yet it is something we find many…

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Webinar: ICH E6 (R2) Overview

March 27, 9:00am – 10:00am ET The session will highlight the key changes made in ICH GCP E6 (R2) which was implemented by the EMA on 14 Jun 2017 and added to the FDA guidance documents on 1 March 2018. This webinar is for anyone wanting a high level understanding of what R2 is, why it has been implemented…

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R2 Implementation and CRO Oversight Case Study

Our client, a large global biopharmaceutical company had recently merged with another similar company. The QA department of the resulting company was met with the task of both integrating two quality management systems as well as preparing for ICH E6 (R2). To add further complexity to their situation, our client was also looking to streamline the number of strategic…

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FDA – ICH E6 R2 Addendum

On March 1, 2018, the Food and Drug Administration (FDA) has announced the availability of the guidance entitled “E6(R2) Good Clinical Practice: Integrated Addendum to E6(R1). “ The guidance amends the guidance entitled “E6 Good Clinical Practice: Consolidated Guidance (E6(R1))” to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting, and…

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The Current State of ICH E6 Revision 2

In November 2017, one of the EMA’s Inspectors, Sophia Mylona, reiterated the importance of Revision 2 (R2) to the attendees at the 5th Global QA conference in Edinburgh, Scotland. Her message surprised the crowd. Not because ICH E6 (R2) is something new. On the contrary, this revision was finalized in November 2016 and put into effect by the EMA…

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2nd Annual European Clinical Quality Oversight Forum

Feb 26-27 at the Radisson Blu Portman Hotel in London UK Tammy Finnigan, Chief Operating Officer, will co-present the pre-conference workshop, Identifying Critical Variables, Assessing Risk and Defining Control Measures for Aligning With ICH E6 R2, during the 2nd European Clinical Quality Oversight Forum. To register, click here  

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INTEGRATED ADDENDUM TO ICH E6(R1): GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R2)

The objective of this ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions. Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve…

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ICH E6 R2 Breakdown by Section

This ICH GCP Guideline Integrated Addendum Breakdown provides a quick overview of the unified standard for the European Union, Japan, the United States, Canada, and Switzerland to facilitate the mutual acceptance of data from clinical trials by the regulatory authorities in these jurisdictions. In the event of any conflict between the E6(R1) text and the E6(R2) addendum text, the…

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Senior Technical Business Analyst (Greater London Based)

Are you looking for a new challenge? We are seeking a Senior Business Analyst for client requirements gathering and project documentation with the company Project Manager and Development team; thoroughly map and measure business workflow/process; document interactions between people, process and technology; collaborate with clients and internal partners; quantify business process capacity, capability and potential savings with improvement recommending…

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