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
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.
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.
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.
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.
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
Pharma and Biotech Industry Associations.
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.
Device Industry Organizations & Other Resources.
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 delivery of innovative products that improve health and quality of life.