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P.O. Box 927595
San Diego, CA 92192-7595

 

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Resources

Regulatory Affairs Resources: Professional Organizations and Education Opportunities

UCI Division of Continuing Education

Offers fully online certificate programs in the following areas: Clinical Trials, Healthcare Analytics, Medical Product Development and Regulatory Affairs.

Discount code provided for SDRAN members to get 10% off of any Life Sciences courses provided.

 

Discount Code: SDRAN10

RAPS

RAPS  Regulatory Affairs Professional Society
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.

TOPRA

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
TOPRA - The (Global) Organisation for Professionals in Regulatory Affairs 
a structured training programs available to them at preferential rates.

ACRP

Association of Clinical Research Professional
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

OCRA  Orange County Regulatory Affairs  Discussion Group
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.

 

UCSD

FDLI

The Food and Drug Law Institute is committed to
FDLI  Food and Drug Law Institute 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 CRA NU

MS in Clinical Regulatory Affairs  NU 
National University offers a Master of Science in Clinical Regulatory Affairs which combines clinical trial research with an understanding of the regulatory process.

SDSU

SDSU offers both a certificate and masters in regulatory affairs. 

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Regulatory Resources USA: FDA and Related Resources

FDA (Food and Drug Administration)

The 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)

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

CMS Center for Medicare and Medicaid Service

For HHS programs, reimbursement, and other information

CLIA Clinical Laboratories Improvement Act

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Outside United States (OUS) Regulatory Resources: Other National Regulatory Agencies and International Regulatory Resources

Health Canada

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 contact Health Canadas Director General's Office and Associate Director General's Office at (613) 957-0368.

EMA

European Medicines Agency (EMA) 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

The 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.

EU Comission

Japan Ministry of Health, Labor and Welfare

ICH

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

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Pharma and Biotech Industry Associations.

PhRMA

The PhRMA represents the leading research-based pharmaceutical and biotechnology companies in the United States.

DIA

DIA is a professional association of more than 18,000 members worldwide who are involved in discovery, development, regulation, surveillance, or marketing of biopharmaceutical products.

May 28, 2023

AACC

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.

National Association of Boards of Pharmacy

A professional organization representing the state boards of pharmacy

CAP

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.

ASCP American Society for Clinical Pathology

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.

Society of Toxicology

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

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Device Industry Organizations & Other Resources.

AMDM Association of Medical Diagnostics Manufacturers

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

AdvaMed is the world's largest medical technology association representing manufacturers of medical devices, diagnostic products and medical information systems.