June 2013

For Pharmaceutical Companies

The New European Pharmacovigilance Legislation

by: Steve Jolley, SJ Pharma Consulting LLC

The new EU pharmacovigilance legislation represents the biggest change to EU pharmacovigilance requirements since the formation of the European Medicines Agency (EMA) and will have a significant impact for regulators and industry. An important reason for companies to take note of the new EU PV laws is the fact that financial penalties to MAHs in Europe were introduced in 2007. For infringements associated with non-compliance for centrally authorized products, penalties can be imposed of up to 5% of total EU annual turnover per annum.

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Disaster Recovery and Validation

by: Louis Rutledge, Manager of Services Development / Validation Services

Disaster! Today’s business world shudders at the word. With the current random occurrences of hurricanes, super storms, earthquakes, blizzards, fires, flooding and sustained power outages, it is a wonder how companies can recover to survive all of the natural or modern threats to their daily business operations and collection of business data. Today’s business world is dependent on the data created and stored for many aspects of daily operations: financial data; product specifications; designs; testing records; and quality management systems (QMS) data are only a few examples. How can you protect your precious data in the face of all these threats?

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Report Highlights Need to Address Root Cause of R&D Inefficiencies

by: Cindy Fazzi, Marketing Communications Specialist, MasterControl Inc.

Pharmaceutical and biotechnology companies need to address the root cause of their drug development inefficiencies. Most companies focus their efforts on “enhanced clinical trial designs” that use biomarkers and adopt advanced statistical analyses, but they still need to hone their efforts at streamlining their drug development process, according to a recent report by the Tufts Center for the Study of Drug Development.

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Pharma Must Provide Convincing Evidence of Drug Value

by: Lynne Taylor, Pharma Times Online

The pharmaceutical industry has now entered the Outcomes Era where compounds must supply convincing evidence of a new drug’s value, with proof of the best possible health outcomes and additional benefits if it is to achieve attractive price and reimbursement levels, says new research.

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