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EU GDP Guidelines: Implications for Shipping Clinical Materials into the European Market

Recently, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) opened an investigation into a patient complaint of mold on paracetamol (acetaminophen) tablets (1). It discovered the product was shipped by sea from India to multiple companies in the UK at temperatures reaching up to 60 degrees Celsius. Labeling for paracetamol tablets typically states they should be kept below 30 degrees Celsius. In addition, MHRA discovered the humidity levels exceeded 80 percent during shipping, which is too high for the packaging that was used.
EU GDP Guidelines: Implications for Shipping Clinical Materials into the European Market
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CPhI expert forecasts ‘huge growth in Middle East manufacturing with Europe a medium-term target’

CPhI Middle East & Africa (CPhI MEA) expert Madhukar Tanna, Chief Executive Officer of Pharmax, a United Arab Emirates (UAE) based branded generic manufacturer, says favourable conditions in the UAE are resulting in a boom of pharmaceutical manufacturing throughout the region. Government incentive schemes to increase domestic production, coupled with a brand friendly environment and rising healthcare needs is fuelling surging demand – with many new companies and plants launching in the last two years alone.
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Maximize the ROI of Your Post-Approval Research

Bioclinica

Expenditures in post-approval (Phase IV) research are going up across the pharmaceutical, biotech and medical device industries. Given the resources you’ve committed to post-approval research, you may be wondering if you’re getting the greatest possible return on your investment. Discover how to harness the power of post-approval research to increase data collection, reduce resource burn, save money, and maximize your ROI!
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Industry Events

PDA Europe Annual Meeting 2019

24 June 2019, Hilton Amsterdam

Featuring updates from international regulatory agencies as well as industry, this promises to become another highlight in the 2019 event calendar and is a meeting not to be missed!
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