Pharmacist Roles in Industrial Clinical Research and Regulatory Affairs

1996 ◽  
Vol 9 (6) ◽  
pp. 444-466
Author(s):  
S. Albert Edwards

This article describes the roles of a pharmacist practicing in the areas of clinical research and regulatory affairs. The article also discusses clinical research and regulatory affairs in the pharmaceutical industry and includes information on what elements of a pharmacy background are useful and relevant, aswell as what a pharmacist can expect in these areas. The future growth of job opportunities is also discussed. Some information is also given on the clinical research process and the underlying scientific method, and selected Food and Drug Administration regulations on clinical research

1989 ◽  
Vol 2 (2) ◽  
pp. 100-104 ◽  
Author(s):  
S. Albert Edwards

The article describes the role of a pharmacist practicing in the area of clinical research for a major food additive company. The article also discusses clinical research in the pharmaceutical industry and includes information on what elements of a pharmacy background are useful and relevant in clinical research, as well as what a pharmacist can expect in this area. The future growth of job opportunities is also discussed. Some information is also given on the clinical research process and the underlying scientific method.


Author(s):  
Joshua M. Sharfstein

The emergence of AIDS in the early 1980s caused a profound crisis for federal health agencies, particularly the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA). Activists in ACT UP, charging that these agencies were failing patients with AIDS, initiated a series of escalating protests. NIH officials, led by Dr. Anthony Fauci, began to talk with the advocates and make major changes in the research process. However, over at the FDA, a protest involving the arrest of hundreds of AIDS activists undermined the agency’s public health image. Eventually, under a new commissioner, the FDA earned back the trust of activists.


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