Bridge the gap: The need for harmonized regulatory and ethical standards for postmarketing observational studies-Reference-Cited by-同舟云学术

Bridge the gap: The need for harmonized regulatory and ethical standards for postmarketing observational studies

Published:2017-08-16 Issue:11 Volume:26 Page:1299-1306
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiol Drug Saf

Author:

Urushihara Hisashi¹^ORCID,Parmenter Louise²,Tashiro Shimon³,Matsui Kenji⁴,Dreyer Nancy⁵^ORCID

Affiliation:

1. Division of Drug Development and Regulatory Science, Faculty of Pharmacy; Keio University; Tokyo Japan

2. Real-World Insights; QuintilesIMS; Berkshire UK

3. Center for Public Health Sciences; National Cancer Center; Tokyo Japan

4. Department of Research Ethics and Bioethics; National Cerebral and Cardiovascular Center; Suita Japan

5. Real-World Insights; QuintilesIMS; Cambridge MA USA

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/pds.4269/fullpdf

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3. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ICH harmonised guideline E17 “General principles for planning and design of multi-regional clinical trials” Step 2 2016

4. Legal requirements, definitions, and standards for non-interventional drug studies: a global picture of variability-results and conclusions from a single-institution survey;Hartmann;Therapeutic Innovation & Regulatory Science,2013

5. Ethics and observational studies in medical research: various rules in a common framework;Claudot;Int J Epidemiol,2009

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