 |
|
LINKS
Regulatory Affairs Resources: Professional organizations and education opportunities 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.
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 programs 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.
SDSU – San Diego State University Extension
http://www.ces.sdsu.edu/Pages/Engine.aspx?id=720UCSD Extension
http://www.extension.ucsd.edu/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.
MS in Clinical Regulatory Affairs – NU
http://www.nu.edu/OurPrograms/SchoolOfHealthAndHumanServices/HealthSciences/Programs/Clinical-Regulatory-Affairs.htmlNational University offers a Master of Science in Clinical Regulatory Affairs which combines clinical trial research with an understanding of the regulatory process.
BIOCOMPASS – CSU
http://www.csubiocompass.org/index.htmlThe California State University system has initiated BIOCOMPASS to provide industry-specific courses and other career and job information. They also offer a certificate in Professional Biotechnology Project Management in Quality Assurance.
Regulatory Resources USA: FDA and related resources FDA (Food and Drug Administration)
http://www.fda.govThe Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments, responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics.
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)
21 CFR regulation search engine
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm
Federal Register search engine
CMS – Center for Medicare and Medicaid Service
http://www.cms.hhs.govFor HHS programs, reimbursement, and other information
CLIA – Clinical Laboratories Improvement Act
Regulatory Resources: Other National Regulatory Agencies and international regulatory resources Health Canada (Canadian Regulatory Agency)
http://www.hc-sc.gc.ca/index-eng.phpHealth 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 contact Health Canada’s Director General's Office and Associate Director General's Office at (613) 957-0368.
European Medicines Agency
http://www.emea.europa.eu/European 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.
MHRA (Medicines and Healthcare products Regulatory Agency)
http://www.mhra.gov.uk/index.htmThe MHRA is an executive agency of the Department of Health of UK which is responsible for ensuring that medicines and medical devices work, and are acceptably safe.
European Commission (information for devices and diagnostics )
http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/index_en.htm
Japan Ministry of Health, Labor and Welfare
List of more International organizations and Foreign Government Agencies
http://www.fda.gov/InternationalPrograms/Agreements/ucm131179.htm
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
Pharma and Biotech Industry Associations PhRMA – Pharmaceutical Research and Manufacturers Association
http://www.phrma.orgThe PhRMA represents the leading research-based pharmaceutical and biotechnology companies in the United States.
Drug Information Agency
http://www.diahome.orgDIA is a professional association of more than 18,000 members worldwide who are involved in discovery, development, regulation, surveillance, or marketing of biopharmaceutical products.
American Association for 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.
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
ASCP – American Society for Clinical Pathology
http://www.ascp.orgA 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.
CAP – College of American Pathologists
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.
LifeScience Alley
https://www.lifesciencealley.org/default.aspxIndustry organization supporting primarily Minnesota’s industry, but with many educational and other events
Device Industry Organizations 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.
Other Resources Medical Dictionary
http://www.merriam-webster.comOn line medical dictionary
RefDesk
http://www.refdesk.comRefdesk indexes quality Internet sites and assists visitors in navigating these sites.
BIOCOM
http://www.biocom.orgBIOCOM is the largest regional life science association in the world, representing more than 550 member companies in Southern California. The association focuses on initiatives that positively influence the region’s life science community in the development and delivery of innovative products that improve health and quality of life.
United States Chamber of Commerce
http://www.uschamber.com/International/default.htmThe U.S. Chamber of Commerce is the world's largest business federation representing 3 million businesses of all sizes, sectors, and regions, as well as state and local chambers and industry associations.
Embassy World – Embassy listings
http://www.embassyworld.comList addresses and contact information for various embassies and field offices
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