Midwest Clinical Supplies Group (MCSG) is a professional organization
that provides a forum for open discussion to share knowledge and
industry best practices for clinical supply and related professionals.
CSForum maintains a professional network,
for everybody involved in the IMP Supply chain,with the objective to improve the performance of IMP processes,
for the benefit of the industry as a whole, participating companies and individual participants.
The FDA is responsible for protecting the public health by assuring the
safety, efficacy, and security of human and veterinary drugs, biological
products, medical devices, our nation's food supply, cosmetics, and
products that emit radiation. The FDA is also responsible for advancing
the public health by helping to speed innovations that make medicines
and foods more effective, safer, and more affordable; and helping the
public get the accurate, science-based information they need to use
medicines and foods to improve their health.
The 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.
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.
NIH is the steward of medical and behavioral research for the Nation.
Its mission is science in pursuit of fundamental knowledge about the
nature and behavior of living systems and the application of that
knowledge to extend healthy life and reduce the burdens of illness and
disability.
USP-NF Online guides users through the pharmaceutical process. It is a
source of FDA-enforceable quality standards for drugs, dietary
supplements, excipients, procedures for tests, assays, analytical
methods, and more.
The European Pharmacopoeia, also known as the EDQM (European Directorate
for the Quality of Medicines & HealthCare, Council of Europe), is
an European Organization involved in harmonization & coordination of
standardization, regulation & quality control of medicines, blood
transfusion, organ transplantation, pharmaceuticals and pharmaceutical
care.
The Centers for Disease Control and Prevention (CDC), a part of the
U.S. Department of Health and Human Services, is the primary Federal
agency for conducting and supporting public health activities in the
United States.
CDC's focus is not only on scientific excellence but also on the
essential spirit that is CDC - to protect the health of all people. CDC
keeps humanity at the forefront of its mission to ensure health
protection through promotion, prevention, and preparedness.
The Center for Drug Evaluation and Research (CDER) performs an essential
public health task by making sure that safe and effective drugs are
available to improve the health of people in the United States.
CBER is the Center within FDA that regulates biological products for
human use under applicable federal laws, including the Public Health
Service Act and the Federal Food, Drug and Cosmetic Act. CBER protects
and advances the public health by ensuring that biological products are
safe and effective and available to those who need them. CBER also
provides the public with information to promote the safe and appropriate
use of biological products.
The Federal Register is the official
daily publication for rules, proposed rules, and notices of Federal agencies
and organizations, as well as executive orders and other presidential
documents.
FDA's Center for Devices and Radiological Health (CDRH) is responsible
for regulating firms who manufacture, repackage, relabel, and/or import
medical devices sold in the United States. In addition, CDRH regulates
radiation-emitting electronic products (medical and non-medical) such as
lasers, x-ray systems, ultrasound equipment, microwave ovens and color
televisions.
The U.S. Government Printing Office (GPO) provides publishing &
dissemination services for the official & authentic government
publications to Congress, Federal agencies, Federal depository
libraries, & the American public.
