Regulatory/Legal

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Mapping the Data Universe: Big Data Presents Big Challenges for the Pharmaceutical Sector - Martin Bonney

Adopting a continual, pro-active approach to information governance is essential if pharmaceutical companies are to meet the challenges presented by big data. Full Article »


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Top 10 Trends that will Shape Pharma

Contributor: Pharma IQ
Posted: 8/22/2013


Top 10 Trends that will Shape Pharma - Pharma IQ

The global pharmaceutical industry has undergone some rapid changes in recent years, but what are the Top 10 Trends that will Shape Pharma. Pharma IQ investigate in this 3 minute video. Full Video »


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Ben Goldacre Makes the Case for Greater Transparency in Clinical Trials - Gerald Clarke

"Clinical trial information is being routinely and legally witheld and this needs to end." This is the assertion of Dr. Ben Goldacre; a doctor, science writer, campaigner on scientific issues including clinical trial transparency and author of the book Bad Pharma. Pharma IQ discussed the issue of clinical trial transparency with Dr. Goldacre, with a focus on how it will affect industry and why pharma companies have taken differing strategies in response to the campaign. Full Podcast »


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Global Regulatory Leadership from European Medicines Agency

Contributor: Mollie Shields-Uehling
Posted: 9/29/2014


Global Regulatory Leadership from European Medicines Agency - Mollie Shields-Uehling

When it comes to greater efficiencies and cost savings in filing electronic submissions, the European Medicines Agency is well ahead of any other regulatory agency on the planet. They're on record stating... The Agency expects the exchange of digitally signed electronic documents to increase the efficiency of procedures and eliminate the need to archive paper documents. It may also bring about cost savings for companies, by removing the need to print documentation and reducing courier charges. Full Column »


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Robust RMP - The Key to Improving PV Standards in Asia?

With the fast evolving regulatory environment in Asia, stricter guidelines on Risk Management Plan (RMP) is expected to kick in that will have far-reaching consequences. These plans are all in accordance to the goal of improving drug safety in the Asian region but addressing the problem head on will not be easy, given the hard challenges that the PV sector faces. This article considers these challenges as well as way to improve PV standards. Full Whitepaper »


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