Resources
Regulatory Bodies
The European Medicines Agency (EMA) is a decentralized body of the European Union responsible for the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. It aims to foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public and animal health.
US Food and Drug Administration (FDA)
The FDA website provides general consumer information related to food, drugs, medical devices, vaccines, blood and biologics, animal & veterinary, cosmetics, radiation-emitting products, and tobacco products. Two sections of particular interest include Science & Research (http://www.fda.gov/ScienceResearch/default.htm) which provides information on running clinical trials and Regulatory Information (http://www.fda.gov/RegulatoryInformation/default.htm) which is a valuable resource for regulatory guidance documents
FDA News provides links to FDA press announcements from 2004 to the present.
International Conference on Harmonisation (ICH)
ICH is a global organization that discusses scientific and technical aspects of drug registration. ICH is a joint initiative involving both regulators and research-based industry representatives of the European Union, Japan, and the USA in scientific and technical discussions of the testing procedures required to assess and ensure the safety, quality, and efficacy of medicines.
Professional Associations/Organizations
American Association of Pharmaceutical Scientists (AAPS)
The American Association of Pharmaceutical Scientists (AAPS) is a professional, scientific association of members employed in industry, academia, government, and other research institutes worldwide. It aims to provide an international forum for the exchange of knowledge among scientists to enhance their contributions to public health. AAPS offers scientific programs, ongoing education, information resources, opportunities for networking, and professional development.
American Society for Quality (ASQ)
The American Society for Quality (ASQ) provides information on quality standards and training in healthcare as well as resources for certification and networking opportunities.
Drug Information Association (DIA)
DIA is a neutral, global, nonprofit association that provides knowledge resources across the full spectrum of medical product development. QC2 exhibits at the DIA Annual Meeting and Annual EuroMeeting each year.
Regulatory Affairs Professionals Society (RAPS)
RAPS is an international membership organization for regulatory professionals who are working to ensure the safety, effectiveness, and availability of healthcare products, including medical devices, pharmaceuticals and biotechnology. RAPs aims to provide the highest level of support, knowledge, direction and standards to the regulatory community.
Society of Clinical Data Management (SCDM)
The Society of Clinical Data Management (SCDM) provides resources on best practices for clinical data management including online courses, credentialing, an annual conference, and online career center.
Society of Quality Assurance (SQA)
SQA is a professional membership organization dedicated to promoting and advancing the principles and knowledge of quality assurance essential to human, animal and environmental health.
Clinical, Pharmaceutical, & Medical Resources
ClinicalTrials.gov is a registry and results database of federally and privately supported clinical trials conducted in the United States and around the world. ClinicalTrials.gov provides information about a trial’s purpose, who may participate, locations, and contact information for more details.
The EU Clinical Trials Register provides information on clinical trials of medicinal products in the EU. Search options allow searches by country, age range, gender, trial phase, trial status, and date range.
This site is a resource for healthcare consumers and professionals providing links to health services and products, alternative health, education, dental and medical resources, hospitals, employment, healthcare publications, and mental health.
PubMed comprises more than 21 million citations for biomedical literature from MEDLINE, life science journals, and online books. Citations may include links to full-text content from PubMed Central and publisher web sites.
