| Regulatory
Affairs Resources: Professional organizations and education opportunities |
TOPRA -
The (Global) Organisation for Professionals in Regulatory Affairs
http://www.topra.org
TOPRA 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.org
ACRP 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.org
OCRA 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.org
The 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.edu |
UCSD Extension
http://www.extension.ucsd.edu/ |
| Regulatory
Resources: National Regulatory Agencies and Non-profit resources |
International
Conference on Harmonization
http://www.ich.org
The 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.html
Health 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.htm
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. |
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.org
A 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&query
On 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.org
An 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.htm
The 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.gov
For HHS programs,
reimbursement, and other information |
Embassy
World – Embassy listings
http://www.embassyworld.com
List addresses
and contact information for various embassies and field offices |
FDLI –
Food and Drug Law Institute
http://www.fdli.org
The 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.com
Refdesk is
indexes quality Internet sites and assists visitors in navigating
these sites. |
MHRA
http://www.mca.gov.uk/
Provides a
lot of useful information re UK regulatory affairs. |
| Pharma
and Biologics Industry Associations |
American
Association of Pharmaceutical Scientists
http://www.aapspharmaceutica.com
Focus groups,
discussions groups and sections for pharmaceutical research |
National
Association of Boards of Pharmacy
http://www.nabp.net
A professional
organization representing the state boards of pharmacy |
Society
of Toxicology
http://www.toxicology.org
A 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.org
Industry organization
supporting primarily Minnesota’s industry, but with many
educational and other events |
PhRMA –
Pharmaceutical Research and Manufacturers Association
http://www.phrma.org
The 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.org
An 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.org
A 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.org
AdvaMed 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.org
The 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.org
Industry organization
supporting primarily Minnesota’s industry, but with many
educational and other events |
| Other
resources |
http://www.fdanews.com
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.org
Life 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.org
The 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. |