European Medicines Agency seeks stakeholders' views on future transparency measures for clinical trials-Reference-Cited by-同舟云学术

European Medicines Agency seeks stakeholders' views on future transparency measures for clinical trials

Published:2023-06-22 Issue:8 Volume:89 Page:2338-2340
ISSN:0306-5251
Container-title:British Journal of Clinical Pharmacology
language:en
Short-container-title:Brit J Clinical Pharma

Author:

Gonzalez‐Quevedo Rosa¹,Pioppo Laura²,Garcia Burgos Juan¹^ORCID,Arlett Peter³^ORCID

Affiliation:

1. Stakeholders and Communication Division European Medicines Agency Amsterdam The Netherlands

2. Data Analytics and Methods Task Force European Medicines Agency Amsterdam The Netherlands

3. Head of Data Analytics and Methods Task Force European Medicines Agency Amsterdam The Netherlands

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://bpspubs.onlinelibrary.wiley.com/doi/pdf/10.1111/bcp.15825

Reference9 articles.

1. European Medicines Agency.Public Consultation on CTIS transparency rules.2023.https://ec.europa.eu/eusurvey/runner/TransparencyRulesPublicConsultationCTIS. Accessed May 11 2023.

2. European Commission.Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use and repealing Directive 2001/20/EC.https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32014R0536. Accessed May 11 2023.

3. European Medicines Agency.Clinical Trials Information System.https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-information-system. Accessed May 11 2023.

4. International Committee of Medical Journal Editors.https://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html. Accessed May 11 2023.

5. European Medicines Agency.Appendix on disclosure rules to the “Functional specifications for the EU portal and EU database to be audited ‐ EMA/42176/2014”.https://www.ema.europa.eu/en/documents/other/appendix-disclosure-rules-functional-specifications-eu-portal-eu-database-be-audited_en.pdf. Accessed May 11 2023.