COVID-19: A Catalyst to Accelerate Global Regulatory Transformation

被引：16

作者：

Stewart, Jerry ^{[1
]}

Honig, Peter ^{[1
]}

AlJuburi, Lina ^{[2
]}

Autor, Deborah ^{[3
]}

Berger, Susan ^{[4
]}

Brady, Patrick ^{[5
]}

Fitton, Helen ^{[6
]}

Garner, Carlos ^{[7
]}

Garvin, Michael ^{[3
]}

Hukkelhoven, Mathias ^{[4
]}

Kowalski, Robert ^{[8
]}

Milligan, Sandra ^{[2
]}

O'Dowd, Liza ^{[9
]}

Reilly, Edward ^{[10
]}

Roberts, Khyati ^{[11
]}

Robertson, Andrew S. ^{[10
]}

Taisey, Mark ^{[12
]}

Thakkar, Roopal ^{[9
]}

Van Baelen, Karin ^{[9
]}

Wegner, Max ^{[5
]}

机构：

[1] Pfizer, Collegeville, PA 19426 USA

[2] Merck, North Wales, PA USA

[3] AstraZeneca, Gaithersburg, MD USA

[4] Bristol Myers Squibb, Princeton, NJ USA

[5] Bayer, Wuppertal, Germany

[6] GlaxoSmithKline, Ware, Herts, England

[7] Eli Lilly & Co, Indianapolis, IN 46285 USA

[8] Novartis, Basil, Switzerland

[9] Janssen, Brussels, Belgium

[10] Sanofi, Paris, France

[11] AbbVie, N Chicago, IL USA

[12] Amgen Inc, Thousand Oaks, CA USA

来源：

CLINICAL PHARMACOLOGY & THERAPEUTICS | 2021年 / 109卷 / 06期

关键词：

D O I：

10.1002/cpt.2046

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

A global crisis the magnitude of coronavirus disease 2019 (COVID-19) can transform drug development and review. It has exposed vulnerabilities and inadequacies in the global healthcare ecosystem as well as spurred innovation, rapid adaption of novel solutions, and unprecedented collaboration among global regulatory agencies, sponsors, and researchers. For the continued and future benefit of patients, it is imperative that all stakeholders leverage the solutions, learnings, and momentum catalyzed by this crisis to advance regulatory science in the drug development process.

引用

页码：1390 / 1392

页数：3

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