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You can still access the UC Berkeley Library’s services and resources during the closure. Here’s how.

OOMPH Library Resources: PHW 236A: Regulatory Science, Drug Development and Public Health: Publications & Literature

Core Public Health Article Databases

Other Databases

SOPs for Regulatory Applications for the Pharmaceutical Industry

Collection of 11 videos (with PDFs of slides) from The Biomedical & Life Sciences Collection, Henry Stewart Talks on topics such as:

  • Effective SOP Writing
  • Procedural assessments of SOPs to ensure SOPs are logical and meet GXP requirements
  • SOP Training
  • Using process mapping, forms and templates for the production of SOPs

Regulatory Agencies require written procedures for all systems and operations which impact the quality and safety of pharmaceutical products. Standard Operating Procedures (SOPs) provide the main forum for the documentation of a pharmaceutical company's systems and operations and compliance with GXP such as GCP, GPV, GMP and GLP.

Grey Literature

Grey Literature generally refers to publications not produced by commercial publishers, including reports (pre-prints, technical reports, market research reports, etc.), theses, conference proceedings, and other documents. They are often produced by government entities, research institutions, or NGOs/IGOs.

Public Health Subject Guides: web pages by topic. Each page consists of annotated lists of organizations, agencies, databases, and publications. Topics include: 
Risk Management;
Pharmaceuticals, Biotechnology, Medical Devices;
Healthcare Industry & Medical Services;
Legislative and Regulatory Resources;
and more.

Google and other search engines can be useful for finding grey literature. Improve your search using: 
• Quotes for phrase searching: 
"drug development" 
• Site: to specify a particular site or domain: 
"drug development" site:.gov (for a domain search);
"drug development" site:fda.gov (for a specific site search) 
• Boolean search statements (eg, OR) (can combine with site searching): 
("drug development" OR "pharmaceutical development") site:.gov

Public Health Librarian

Michael Sholinbeck's picture
Michael Sholinbeck
(he/him)

Schedule an online consultation,
or visit during my online office hours Thursdays 1-3pm
(Contact me for Zoom info)
Contact:
Subjects:Public Health

Selected Online Books