SDRAN

RESOURCES

Regulatory Affairs Resources: Professional Organizations and Education Opportunities

ACRP

Association of Clinical Research ProfessionalACRP 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....

FDLI

The Food and Drug Law Institute is committed toFDLI  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. VISIT SITE

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. VISIT SITE

SDSU

SDSU offers both a certificate and masters in regulatory affairs.  VISIT SITE

TOPRA

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 ofTOPRA – The (Global) Organisation for Professionals in...

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...

UCSD

Recognized as one of the top 15 research universities worldwide, our culture of collaboration sparks discoveries that advance society and drive economic impact. Everything we do is dedicated to ensuring our students have the opportunity to become changemakers,...

Regulatory Resources USA: FDA and Related Resources

CMS Center for Medicare and Medicaid Service

For HHS programs, reimbursement, and other information VISIT SITE

FDA (Food and Drug Administration)

Regulatory Resources USA: FDA and Related Resources 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...

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) VISIT SITE

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

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...

EU Comission

VISIT SITE

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...

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...

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. VISIT SITE

Pharma and Biotech Industry Associations

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. VISIT SITE

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,...

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. VISIT SITE

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. VISIT SITE

National Association of Boards of Pharmacy

A professional organization representing the state boards of pharmacy VISIT SITE

PhRMA

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

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 VISIT SITE

Device Industry Organizations & Other Resources

Advamed

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

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 VISIT SITE

BIOCOM

BIOCOM 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 regions life science community in the development and...

FDA News

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 VISIT SITE