As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to European Commission in 2021 about ACRO Policy Recommendations for Guidance on Electronic Systems and Electronic Data in Clinical Trials can be found below.
As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to European Commission in 2021 about Online Survey Consultation on European Health Data Space (July 2021) can be found below.
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As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to European Commission in 2021 about Supplemental comment on European Commission Consultation on the Revision of the General Pharmaceutical Legislation can be found below.
As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2021 about Requirements for quality documentation concerning biological investigational medicinal products in clinical trials (EMA/CHMP/BWP/534898/2008 rev. 2 corrigendum) can be found below.
As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2021 about Requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials (EMA/CHMP/QWP/31884/2021) can be found below.
As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2021 about Comment on EMA Draft Guideline on Computerised Systems and Electronic Data in Clinical Trials (EMA/226170/2021) can be found below.
As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2022 about EMA Draft Guidance on the Protection of Personal Data and Commercially Confidential Information in Documents Uploaded and Published in the CTIS (EMA/212507/2021) can be found below.
As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2022 about Public Consultation Concerning the Physical Attendance and the Location Of Personal Residency of the Qualified Person (EMA/INS/169000/2022) can be found below.
As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to ICH in 2023 about ICH M11 Clinical Electronic Structured Harmonised Protocol – Guideline can be found below.
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As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to ICH in 2023 about ICH M11 Clinical Electronic Structured Harmonised Protocol – Template can be found below.
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