Regulatory Science and Innovation Programme for Europe (ReScIPE): A proposed model-Reference-Cited by-同舟云学术

Regulatory Science and Innovation Programme for Europe (ReScIPE): A proposed model

Published:2019-10-17 Issue:12 Volume:86 Page:2530-2534
ISSN:0306-5251
Container-title:British Journal of Clinical Pharmacology
language:en
Short-container-title:Br J Clin Pharmacol

Author:

Hines Philip A.¹²^ORCID,Guy Richard H.¹³⁴,Brand Angela²⁵,Humphreys Anthony J.¹,Papaluca‐Amati Marisa¹

Affiliation:

1. European Medicines Agency Amsterdam The Netherlands

2. United Nations University—Maastricht Economic and Social Research Institute on Innovation & Technology (UNU‐MERIT), Maastricht University Maastricht The Netherlands

3. Centre for Therapeutic Innovation, Department of Pharmacy & Pharmacology University of Bath Claverton Down Bath UK

4. Department of Bioengineering and Therapeutic Sciences, UCSF University of California—San Francisco (UCSF)—Stanford Center of Excellence in Regulatory Science & Innovation San Francisco CA USA

5. Department of International Health, Faculty of Health, Medicine and Life Sciences (FHLM) Maastricht University Maastricht The Netherlands

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/bcp.14099

Reference19 articles.

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2. European Medicines Agency.Draft guideline on quality non‐clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials.https://www.ema.europa.eu/en/guideline‐quality‐non‐clinical‐clinical‐requirements‐investigational‐advanced‐therapy‐medicinal. Accessed August 30 2019.

3. European Medicines Agency.Questions & answers on implementation of the medical devices and in vitro diagnostic medical devices regulations ((EU) 2017/745 and (EU) 2017/746).https://www.ema.europa.eu/en/human‐regulatory/overview/medical‐devices. Accessed August 30 2019.

4. Heads of medicines agencies/European medicines agency joint big data taskforce – summary report.https://www.ema.europa.eu/en/about‐us/how‐we‐work/big‐data. Accessed August 30 2019.

5. Unmet needs: Research helps regulators do their jobs

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