background graphic background female face (petri dish)
Specialized education and professional development are critical to the clinical trials professionals.

 

Next admission cycle is for Spring Semester 2009. The deadline for applications is:
Nov. 1, 2008.

Is Distance Learning for You? Take the Self Assessment Quiz.

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 Let us also know if you find an outdated or broken link so we may replace it.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



Return to the top background graphic (test tubes)