Tag Archive: regulations

Bart’s Corner: EU Pharmacovigilance Inspection Update

Several documents were published by the EMA and went into effect in June 2014 regarding EU Pharmacovigilance (PV) inspections. Some of the more important points are summarized here: Inspection Findings Impacting the Benefit-Risk Profile The Pharmacovigilance Risk Assessment Committee (PRAC) adopted a new procedure entitled: “Union procedure on the management[…]

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FDA Webinar on Social Media Guidance

The FDA held a webinar last week regarding their recently-issued Social Media Guidance documents. Though many who registered were unable to access the webinar due to technical difficulties, the presentations slides and Q&A document were posted to the FDA website. In reviewing the slides, there were no major revelations presented[…]

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Data Monitoring Committees: Observations & Issues – Part II

In Part 1 of this post we started the review of some practical issues in the management and functioning of DMCs. We conclude here. Pushback I have seen situations where the sponsor uses the DMC only grudgingly and really does not want the DMC to act as an independent body[…]

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5 Best Practices for Pharma Social Media

The FDA’s most recent guidance has sparked lots of questions and conversations about how Pharmaceutical companies can effectively use social media. Given the regulatory challenges in social media, here are 5 best practices for pharmaceutical companies interested in using social media: Identify clear and specific objectives that lend themselves to[…]

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Safeguarding Patient Data – Part Two: 5 Tips for Maintaining a Constant Working Posture for Privacy

In our last post on safeguarding patient data, we discussed the opportunities and challenges facing healthcare companies with today’s increase focus on data, including the high stakes of a patient data security breach. For every industry, there are multiple entities that proactively assist a corporation in their recognition and enforcement[…]

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Safeguarding Patient Data – Part One: More Data, More Opportunities for a Breach

Data. Indeed, it may be one of year’s biggest buzzwords, but data’s impact and possibilities for the healthcare industry continue to have many insiders, myself inclused, very excited. Its potential for increased efficiencies and effectiveness in providing a more comprehensive care is vast. But many questions still remain: how do[…]

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FDA Social Media Pharma Guidance

FDA Issues Social Media Guidance for Pharma

If you own “it,” finance “it” or influence “it” you are responsible for “it.”  In essence that’s what the FDA recently said in their draft guidance on “Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics.” Finally, the FDA has provided[…]

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Generic Safety Labeling: FDA’s new regulation – Part 1

On November 8, 2013 FDA published an announcement in the Federal Register regarding new labeling requirements for generic drugs.  (See http://telerx.bz/3n) It was officially published November 13, 2013.  There will be a 60 day comment period and then, presumably, FDA will make the regulations final and they will take effect –[…]

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