Regulatory Affairs

Regulatory Affairs is a professional discipline that ensures pharmaceutical and medical products comply with applicable regulatory requirements through the management of regulatory submissions, coordination with health authorities, and oversight of compliance activities throughout the product lifecycle.

1.8K

Publications

64K

Citations

3.7K

Authors

1.4K

Institutions

Publications per year

2017–2026

364

Parents

Regulatory Pharmacy

Children

Advertising ComplianceChange ControlDevice RegulationDossier PreparationGlobal Regulatory HarmonizationHealth Authority InteractionsInspectionLabeling ComplianceLabeling RequirementsManufacturing Compliance

Publications

1.8K

Why a Right to Explanation of Automated Decision-Making Does Not Exist in the General Data Protection Regulation

Sandra Wachter, Brent Mittelstadt, Luciano Floridi · International Data Privacy Law · 2017 · 1.1K citations · Full text

Law, Administrative Law, Regulatory Policy +14

The Federal Communications Commission

R. H. Coase · The Journal of Law and Economics · 1959 · 1.1K citations

Social Sciences, Communication, Regulatory Affairs +5

The Federal Communications Commission

R. H. Coase · The Journal of Law and Economics · 2013 · 788 citations

Social Sciences, Communication, Regulatory Affairs +5

Health industry practices that create conflicts of interest: a policy proposal for academic medical centers.

Troyen A. Brennan, David J. Rothman, Linda L. Blank et al. · PubMed · 2006 · 705 citations

Pharmacy, Health Law, Pharmaceutical Policy +13

Summary Indicators of Product Market Regulation with an Extension to Employment Protection Legislation

Giuseppe Nicoletti, Stéfano Scarpetta, Oliver Boylaud · SSRN Electronic Journal · 2000 · 476 citations · Full text

Public Affairs, Regulatory Policy, Regulatory Affairs +15

1–5 of 1.8K

Authors

3.7K

SA
Stanton A. Glantz
University of California, San Francisco, United States
12 publications · 438 citations
11
h-index
AG
Anna Gilmore
University of Bath, United Kingdom
8 publications · 335 citations
8
h-index
SA
Stella Aguinaga Bialous
University of California, San Francisco, United States
7 publications · 419 citations
7
h-index
PF
Peter Forsyth
Monash University, Australia
5 publications · 179 citations
5
h-index
MM
Michelle M. Mello
Harvard University, United States
5 publications · 360 citations
5
h-index

1–5 of 3.7K

Institutions

1.4K

1–8 of 1.4K

Venues

SSRN Electronic Journal
Repository · 96 publications · 4K citations
29
h-index
Tobacco Control
44 publications · 1.8K citations
26
h-index
New England Journal of Medicine
NEJM · 27 publications · 2.1K citations
20
h-index
PubMed
Repository · 51 publications · 1.8K citations
19
h-index
Telecommunications Policy
31 publications · 803 citations
18
h-index

1–5

See also Regulatory Affairs
Core Processes	Pharmacovigilance Dossier Preparation Post-market Surveillance Compliance Auditing Regulatory Intelligence Change Management Regulatory Submissions
Submission Types	Investigational New Drug Applications New Drug Applications Biologics License Applications
Lifecycle Strategy	Post-marketing Surveillance Change Management Regulatory Intelligence Convergence Of Product Standards Lifecycle Governance Regulatory Sandboxes Regulatory Traceability
Compliance Frameworks	Good Laboratory Practice Good Manufacturing Practice Occupational Safety Data Compliance Management Post-marketing Surveillance Capability Maturity Model Integration Six Sigma
Health Authorities	World Health Assembly