Clinical Trials -
General Web Resources
Specific topics:
Below are lists of useful web links for course work and professional needs.
If you find a site that you believe would be useful to other regulatory affairs professionals, please email that url to regaffairs@rx.uga.edu. Let us also know if you find an outdated or broken link so we may replace it. Thank you.
US Government Links
US Government Printing Office: www.gpoaccess.gov
FDA GMP Regulations (CFR21): www.access.gpo.gov/nara/cfr/waisidx
_01/21cfr211_01.html
The Code of Federal Regulations (CFR): www.gpoaccess.gov/cfr/index.html
US Food and Drug Administration: www.fda.gov
The Center for Biologics Evaluation and Research (CBER): www.fda.gov/cber/
CBER Guidelines:
www.fda.gov/cber/guidelines.htm
Office of Regulatory Affairs (ORA):
www.fda.gov/ora/
Federal Food, Drug, and Cosmetic Act: www.fda.gov/opacom/laws/fdcact/fdctoc.htm
FDA Modernization Act (FDAMA): www.fda.gov/cdrh/modact/modern.html
Good Guidance Practices (GGP): www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfggp/search.cfm
Product Classification Database: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD
/classification.cfm
International Program:
www.fda.gov/cdrh/international
Investigation Operation Manual: www.fda.gov/ora/inspect_ref/iom/iomtc.html
Inspection Reference: www.fda.gov/ora/inspect_ref/igs/iglist.html
The Center for Drug Evaluation and Research (CDER): www.fda.gov/cder/index.html
cGMP Human Drugs GMP Notes: www.fda.gov/cder/index.html
The Center for Devices and Radiological Health (CDRH): www.fda.gov/cdrh/index.html
Medical Device Reporting Home Page: www.fda.gov/cdrh/mdr/
Listing Searchable Database: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/Listing/search.cfm
The Center for Food Safety & Applied Nutrition (CFSAN): vm.cfsan.fda.gov/list.html
The Center for Veterinary Medicine (CVM): www.fda.gov/cvm/default.html
FDA New Releases: www.fda.gov/opacom/hpnews.html
US Department of Agriculture: www.usda.gov
Laws and Regulations:
www.usda.gov/LawsAndRegulations/
Centers for Disease Control: www.cdc.gov
Department of Health and Human Services (HHS): www.dhhs.gov
National Institutes of Health (NIH): www.nih.gov
National Cancer Institute (NCI): www.nci.nih.gov
Journal of the National Cancer Institute: http://jncicancerspectrum.oupjournals.org
The National Library of Medicine: www.nlm.nih.gov
The Visible Human Project: www.npac.syr.edu/projects/vishuman/
National Institute of Allergy and Infectious Diseases, National Institutes
of Health www.niaid.nih.gov
National Foundation for Infectious Diseases: www.nfid.org
National Science Foundation (NSF): www.nsf.gov
U.S. Environmental Protection Agency (EPA): www.epa.gov
Global Harmonization: www.ghtf.org
Regulatory Affairs Resource Links
Regulatory Affairs Information: www.rainfo.com
Regulatory Affairs Professionals Society (RAPS): www.raps.org/s_raps/index.asp
AdvaMed (Advanced Medical Technology Association): www.advamed.org
UGA and USG Resource Links
UGA Libraries: www.libs.uga.edu
GALILEO: The University System of Georgia electronic database: www.galileo.usg.edu
UGA College of Pharmacy Millikan Educational Resources Center (M.E.R.C.):
www.rx.uga.edu/main/home/merc/mercpage/
Through the M.E.R.C website, you can gain access to the following journals
at www.rx.uga.edu/main/home/merc/mercpage/pharm_ejournal.html
Science Direct, Elsevier Science, IPA, Annual Review, and AACP Basic
Recourses.
You can also search the College of Pharmacy's holdings at www.rx.uga.edu/cgi-bin2/libsearch.exe
The New England Journal of Medicine: http://content.nejm.org/
(Password Protected. You may access this on-line journal using a UGA College
of Pharmacy password. Please contact the Regulatory Affairs Program for
UGA Pharmacy password: regaffairs@rx.uga.edu
or 678-407-5277. You must be registered student to receive this password.)
Life Science & Medical Links
Access Excellence, The National Health Museum: www.accessexcellence.org/
Vaccines: www.accessexcellence.org/AE/AEC/CC/vaccines_how_why.html
The American Medical Association:
www.ama-assn.org/
The Journal of the American Medical Association: www.ama-assn.org/apps/gk?http://jama.ama-assn.org/
The New England Journal of Medicine: http://content.nejm.org/
(Password Protected. You may access this on-line journal using a UGA College
of Pharmacy password. Please contact the Regulatory Affairs Program for
UGA Pharmacy password: regaffairs@rx.uga.edu
or 678-407-5277. You must be registered student to receive this password.)
Center for Human Simulation: www.uchsc.edu/sm/chs/
Development of Polio Vaccines: www.accessexcellence.org/AE/AEC/CC/polio.html
DNA Vaccine Information Site: http://dnavaccine.com/
Epidemic! The World of Infectious Disease: www.amnh.org/exhibitions/epidemic/
Molecular Expressions: micro.magnet.fsu.edu/index.html
The Vaccine Page (from UniScience.net): http://vaccines.org/
The National Library of Medicine: www.nlm.nih.gov
The Visible Human Project: www.npac.syr.edu/projects/vishuman/
Scientific Journal Links
BioMed Central: www.freemedicaljournals.com
Blood Cells, Molecules, & Diseases: www.scripps.edu/bcmd/
British Medical Journal:www.bmj.com
British Pharmacopoeia: www.pharmacopoeia.org.uk
Doctor's Guide Journal Directory: www.docguide.com
Free Medical Journals: www.freemedicaljournals.com
High Wire: highwire.stanford.edu
Journal of Biotechnology: www.elsevier.com
The Journal of Infectious Diseases: www.journals.uchicagoss.edu/JID/
Journal of Virology: http://jvi.asm.org
MedBioWorld (lists of Bioscience Journals): www.medbioworld.com/bio/journals/bio-journals.html
Nature Immunology (from Nature Publishing Group): www.nature.com/ni/
United States Pharmacopoeia: www.usp.org
International Links
CANADA
Canada Health, Therapeutic Products Directorate: www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/
EUROPE (UK links will have separate entry)
European Commission's Pharmacos: http://dg3.eudra.org/home.html
EudraLex: The Rules Governing Medicinal Products in the European Union:
http://pharmacos.eudra.org/F2/eudralex/index.htm
European Guide to GMP: http://pharmacos.eudra.org/F2/eudralex/vol-4/home.htm
European Guide to GMP-updates: http://pharmacos.eudra.org/F2/pharmacos/gmp_doc.htm
The European Medicines Agency: www.emea.eu.int/
European Guidelines on Quality, Safety & Efficacy: www.emea.eu.int/sitemap.htm
Mutual Recognition Agreements: www.emea.eu.int
European Federation of Pharmaceutical Industries & Federations: www.efpia.org
European Pharmacopoeia: Mutual Recognition Agreements Status: www.pheur.org
ASIA (including Australia)
Japanese Ministry of Health, Labour & Welfare: www.mhlw.go.jp/english/
Australian Department of Health and Aging: www.health.gov.au/
Therapeutic Goods Administration, Australian Regulatory Agency: www.health.gov.au/tga/
UNITED KINGDOM
United Kingdom Department of Health: www.dh.gov.uk/Home/fs/en
UK Medicines Control Agency: www.mca.gov.uk/
WORLD
World Health Organization: www.who.int/en/
World Health Organization's Essential Drugs and Medicines Policy: www.who.int/medicines/organization/qsm/activities/
qualityassurance/gmp/gmpcover.html
International Pharmaceutical Federation: www.fip.org
International Pharmaceutical Excipients Council: www.ipec.org
Meningitis Vaccine Project: www.meningvax.org/
Professional Associations and Societies
Regulatory Affairs Professional Society (RAPS): www.raps.org
AdvaMed (Advanced Medical Technology Association):www.advamed.org
Pharmaceutical Research & Manufacturers of America (phRMA): www.phrma.org
Pharmaceutical Inspection Co-operation Scheme (GMP Guide & Basic Standards): www.picscheme.org/index.htm
PDA, Parenteral Drug Association, an International Association for Pharmaceutical Science and Technology: www.pda.org
Biotechnology Industry Organization (BIO): www.bio.org
The Food and Drug Law Institute (FDLI): www.fdli.org
National Foundation for Infectious Diseases: www.nfid.org
National Organization for Rare Disorders (NORD): www.rarediseases.org
International Federation of Pharmaceutical Manufacturers Association, (IFPMA): www.ifpma.org
The International Conference on Harmonisation of Technical Requirements
for Registration of Pharmaceuticals for Human Use (ICH): www.ich.org/UrlGrpServer.jser?@_ID=276&@_TEMPLATE=254
ICH Guidelines at the IFPMA site: www.ich.org/TxtServer.jser?@_ID=250&@_TEMPLATE=272
The Society for Life Science Professionals: www.ispe.org
Reference Sites
Acronym Finder: www.acronymfinder.com
Dictionary: www.dictionary.com
International Organization for Standardization: www.iso.ch/iso/en/aboutiso/introduction/index.html
Weights & Measures: www.ex.ac.uk/cimt/dictunit/dictunit.htm; www.convert-me.com/en/; http://chemistry.berkeley.edu/links/weights/index.html
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