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Tuesday, February 26, 2013
February 26, 2013 DOJ to Target Pharma and Device Current Good Management Practices (cGMPs) Violations
Over the last several years, we have written extensively about the ongoing government prosecution of pharmaceutical and medical device manufacturers involved in off-label promotion, misbranding, and other illegal marketing and promotional activities. Much of the focus and resources of the federal government, including the US Department of Justice (DOJ), the Department of Health and Human Services (HHS), and the Office of the Inspector General (OIG) for HHS have been devoted to investigating and prosecuting such large-scale cases, including the largest in history—a $3 billion fine against GlaxoSmithKline.
While the ongoing prosecution of these cases into the future likely will remain stable despite the U.S. Second Circuit’s decision in United States v. Caronia, DOJ recently announced in late January of this year, that compliance with current good manufacturing practices (cGMPs) will be one of the agency's “top areas of focus” in the coming year, “opening up new areas of uncertainty for those involved in compliance and regulatory activities for the pharmaceutical industry,” writes RAPS.
cGMP regulations are designed to assure that drugs meet safety, identity, and strength requirements and that they meet the quality and purity characteristics which they are represented to possess.
- See more at: http://www.policymed.com/2013/02/doj-to-target-pharma-and-device-current-good-management-practices-cgmps-violations.html#sthash.j9xBJxUa.dpufPCCA Pain and Nutrition Symposium April 4-6, 2013 in Grapevine, Texas
Published on Feb 26, 2013
PCCA Pain and Nutrition Symposium
April 4-6, 2013
Gaylord Texan Resort & Conference Center - Grapevine, Texas
Pain management is a hot topic in compounding pharmacy these days. It is important to be able to determine the type of pain, the receptors involved, and the various drugs available to successfully help the patient improve their quality of life. Nutrition plays a huge role in the management of pain, including food and nutritional supplements that can complement compounded medications.
This event is designed for pharmacists and practitioners, will offer CE/CME, and has a clinical focus. Three physicians will be speaking at this conference, discussing sports medicine, myofascial pain, neuropathic pain, as well as lyme disease and arthritis. Additionally, a component of this event will also cover nutrition and nutritional supplements related to pain management. This event is designed to provide you with the didactic knowledge needed to treat patients suffering from pain. Concepts such as transdermal delivery will be discussed as well.
Speakers include: Hal Blatman, MD; James LaValle, RPh, MS, ND, CCN; Pamela Smith, MD, MPH; Mazen Baisa, PharmD, MBA, ABAAHP, FAARM, Dip.DSC, and PCCA Pharmacy Consultant Andy Glasnapp, PharmD.
You can get more details and register for this event at www.pccarx.com/education
April 4-6, 2013
Gaylord Texan Resort & Conference Center - Grapevine, Texas
Pain management is a hot topic in compounding pharmacy these days. It is important to be able to determine the type of pain, the receptors involved, and the various drugs available to successfully help the patient improve their quality of life. Nutrition plays a huge role in the management of pain, including food and nutritional supplements that can complement compounded medications.
This event is designed for pharmacists and practitioners, will offer CE/CME, and has a clinical focus. Three physicians will be speaking at this conference, discussing sports medicine, myofascial pain, neuropathic pain, as well as lyme disease and arthritis. Additionally, a component of this event will also cover nutrition and nutritional supplements related to pain management. This event is designed to provide you with the didactic knowledge needed to treat patients suffering from pain. Concepts such as transdermal delivery will be discussed as well.
Speakers include: Hal Blatman, MD; James LaValle, RPh, MS, ND, CCN; Pamela Smith, MD, MPH; Mazen Baisa, PharmD, MBA, ABAAHP, FAARM, Dip.DSC, and PCCA Pharmacy Consultant Andy Glasnapp, PharmD.
You can get more details and register for this event at www.pccarx.com/education
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