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LINKS
Regulatory Affairs Resources: Professional organizations and education opportunities TOPRA - The (Global) Organisation for Professionals in Regulatory Affairs
http://www.topra.orgTOPRA is a non-profit, non-political international organization, which seeks to advance the status of the regulatory profession through education, and provision of information to its members. Members have the advantage of a structured training programme available to them at preferential rates.
Association of Clinical Research Professional
http://www.acrpnet.orgACRP is the primary resource for clinical research professionals in the pharmaceutical, biotechnology, and medical device industries, as well as those in hospital, academic medical centers, and physician office settings.
OCRA – Orange County Regulatory Affairs – Discussion Group
http://www.ocra-dg.orgOCRA is a volunteer organization made up of individuals from the Southern California area that are interested in networking with others involved in regulatory affairs. Our membership includes individuals that work in pharmaceutical, medical device, biologic and IVD industries.
RAPS – Regulatory Affairs Professional Society
http://www.raps.orgThe Regulatory Affairs Professionals Society (RAPS) is the foremost worldwide member organization creating and upholding standards of ethics, credentialing and education for the regulatory affairs (RA) profession within the health product sector.
SDSU – San Diego State University
http://www.sdsu.eduUCSD Extension
http://www.extension.ucsd.edu/Regulatory Resources: National Regulatory Agencies and Non-profit resources International Conference on Harmonization
http://www.ich.orgThe International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration
Health Canada (Canadian Regulatory Agency)
http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/index_e.htmlHealth Canada's Therapeutic Products Directorate is the Canadian federal authority that regulates pharmaceutical drugs and medical devices for human use. Prior to being given market authorization, a manufacturer must present substantive scientific evidence of a product's safety, efficacy and quality as required by the Food and Drugs Act and Regulations. For further information, call (613) 957-0368.
European Medicines Agency
http://www.emea.eu.int/htms/aboutus/emeaoverview.htmEuropean Medicines Agency (EMEA) is a decentralized body of the European Union with headquarters in London. Its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. The EMEA coordinates the evaluation and supervision of medicinal products throughout the European Union.
HIPAA (HHS)
http://www.hhs.gov/ocr/hipaa/The USA Health and Human Services website for information on National Standards to Protect the Privacy of Personal Health Information (e.g., for clinical trials information
Drug Information Agency
http://www.diahome.orgA member-driven organization encompassing the full continuum of disciplines in the pharmaceutical and related industries and to be valued as the professional development authority.
Medical Dictionary
http://cancerweb.ncl.ac.uk/cgi-bin/omd?action=Home&queryOn line medical dictionary
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm
21 CFR regulation search engine
http://www.accessdata.fda.gov/scripts/oc/ohrms/index.cfm
Federal Register search engine
http://www.fda.gov/opacom/hpwhats.html
Free daily e-news downloads from FDA
American Association of Clinical Chemistry
http://www.aacc.orgAn international scientific/medical society of clinical laboratory professionals, physicians, research scientists and other individuals involved with clinical chemistry and other clinical laboratory science-related disciplines.
United States Chamber of Commerce
http://www.uschamber.com/International/default.htmThe U.S. Chamber of Commerce improves the ability of U.S. businesses to compete in the global marketplace by providing its members valuable tools and resources, as well as cutting-edge events that bring world leaders to our members.
CMS – Center for Medicare and Medicaid Service
http://www.cms.hhs.govFor HHS programs, reimbursement, and other information
Embassy World – Embassy listings
http://www.embassyworld.comList addresses and contact information for various embassies and field offices
FDLI – Food and Drug Law Institute
http://www.fdli.orgThe Food and Drug Law Institute is committed to providing high quality education and a neutral forum for the generation of ideas and discussion of law and public policy for its legal, policy and regulatory communities.
RefDesk
http://www.refdesk.comRefdesk is indexes quality Internet sites and assists visitors in navigating these sites.
Provides a lot of useful information re UK regulatory affairs.
Pharma and Biologics Industry Associations American Association of Pharmaceutical Scientists
http://www.aapspharmaceutica.comFocus groups, discussions groups and sections for pharmaceutical research
National Association of Boards of Pharmacy
http://www.nabp.netA professional organization representing the state boards of pharmacy
Society of Toxicology
http://www.toxicology.orgA professional and scholarly organization of scientists from academic institutions, government, and industry representing the great variety of professionals who practice toxicology in the U.S. and abroad. Has a good page of URL links
Medical Alley
http://www.medicalalley.orgIndustry organization supporting primarily Minnesota’s industry, but with many educational and other events
PhRMA – Pharmaceutical Research and Manufacturers Association
http://www.phrma.orgThe PhRMA represents the leading research-based pharmaceutical and biotechnology companies in the United States.
Device Industry Organizations American Association of Clinical Chemistry
http://www.aacc.orgAn international scientific/medical society of clinical laboratory professionals, physicians, research scientists and other individuals involved with clinical chemistry and other clinical laboratory science-related disciplines.
AMDM – Association of Medical Diagnostics Manufacturers
http://www.amdm.orgA nonprofit trade association that serves as a resource for education and information on compliance issues between member companies and as an interface between member companies (IVDs) and the FDA
Advamed
http://www.advamed.orgAdvaMed is the world's largest medical technology association representing manufacturers of medical devices, diagnostic products and medical information systems.
ASCP – Association for Clinical Pathology
http://www.ascp.orgThe American Society for Clinical Pathology (ASCP) is a not-for-profit medical society organized exclusively for educational, scientific, and charitable purposes. The mission of the American Society for Clinical Pathology is to provide excellence in education, certification, and advocacy on behalf of patients, pathologists, and laboratory professionals.
Medical Alley
http://www.medicalalley.orgIndustry organization supporting primarily Minnesota’s industry, but with many educational and other events
Other resources A provider of domestic and international regulatory, legislative and business news and information for executives in industries regulated by the U.S. Food and Drug Administration and The European Commission, including some free e-newsletters
BioCom
http://www.biocom.orgLife science industry association representing more than 450 member companies in San Diego and Southern California. The association focuses on initiatives that positively influence the growth of the life science industry, including capital formation, public policy, workforce development, and scientific discovery and development.
CAP – College of American Pathologist
http://www.cap.orgThe College of American Pathologists, the principal organization of board-certified pathologists, serves and represents the interest of patients, pathologists, and the public by fostering excellence in the practice of pathology and laboratory medicine.