New Approaches to Regulatory Innovation Emerging During the Crucible of COVID-19 : In Responding to a Global Health Crisis, Industry is Discovering New, Efficient Ways of Meeting Objectives.
Ther Innov Regul Sci
; 55(2): 463-466, 2021 03.
Article
in English
| MEDLINE | ID: covidwho-1064673
ABSTRACT
The urgency and impact of the ongoing COVID-19 pandemic are changing global drug development and regulatory processes. The need for speed to understand the virus and develop new vaccines, medicines, and therapies for patients has provided unprecedented learning opportunities and revealed how the pharmaceutical industry can improve upon traditional processes. To stay competitive while remaining compliant with agency regulations and guidance, companies need to implement new process/tools that allow for more flexible work models, consider expanding the use of decentralized/hybrid trials, and capitalize on the use of real-world evidence (RWE) and cloud-based data systems. In addition, regulatory agencies should retain the agility exhibited during current reviews of potential new therapies, applying this momentum to other areas of unmet medical need. Further, agencies should consider a globally acceptable application platform. This article, by the Pharmaceuticals' Head of Regulatory Affairs at Bayer AG, examines how impacts of the COVID-19 crisis will continue beyond the pandemic period to the benefit of patients, drug developers, regulators, clinicians, and caregivers.
Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Drug Industry
/
Drug Development
/
Teleworking
/
COVID-19
Type of study:
Observational study
/
Prognostic study
Topics:
Vaccines
Limits:
Humans
Language:
English
Journal:
Ther Innov Regul Sci
Year:
2021
Document Type:
Article
Affiliation country:
S43441-020-00239-8
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