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Regulatory Considerations DMEG

Regulatory Considerations Expert Group

The Regulatory Considerations Expert Group looks at providing guidance information on a number of areas surrounding regulations. These include, where to find regulations and being aware of any new ones. Which parts are relevant to data management and what they mean. The expectations and recommendations on implementation and what data management needs to be prepared for in readiness for inspection.
 
The Regulatory Considerations group aims to further the development and skill-set of our wider ACDM community and would be delighted to invite members to our team. We look forward to hearing from you.
 
If you have any interest in joining this group, please click here.

Regulatory Considerations Expert Group outputs​

ICH E8 (R1) General Considerations for Clinical Studies Impact on Data Management
Date: April 5, 2022
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ACDM Comments on “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations; Draft Guidance for Industry, Investigators, and Other Stakeholders; Availability”
Date: April 5, 2022
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EMA submission of comments on ‘Guideline on computerised systems and electronic data’
Date: January 27, 2022

Click to access output

ICH E6 Guideline for Good Clinical Practice (GPC) – Update on Progress
Date: June 8, 2021

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Data Integrity in Global Clinical Trials
Date: May 27, 2021

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FDA 21 CFR Part 11 Subpart B Electronic Records Requirements & Annex 11 Computerised Systems – Suggested Implementation
Date: May 13, 2021

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Regulatory Considerations Expert Group members

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Silvia Perez Torres (Chair)
Associate Director, Clinical Quality Compliance
AstraZeneca

Bertrand Le Bourgeois
President PharMarketing
PharMarketing

Yiannis Karageorgos
Manager of External Data Integration and Data Provisioning
Bristol-Myers Squibb

Raven Brothers
Associate Director of Clinical Data Abstraction
Natera

Alex Franklin
Project DM Director – Immuno-Oncology
GSK

Julianne Hull
CEO
WenStar Enterprises

Karine Renault
Senior Quality Consultant
PharMarketing