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Pharma Lessons
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pharmaceutical, training, courses, gcp, gmp, gdp, biotech, clinical
pharmaceutical, training, courses, gcp, gmp, gdp, biotech, clinical

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The US FDA has issued a policy that provides the proper definition of an outsourcing facility in an effort to ensure compounded drugs are made under appropriate quality standards. Read more:

https://lnkd.in/gjccVKW
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Advances in cloud technology, mobile communications, big data and AI are disrupting the health sector, resulting in organisations experimenting with a wide range of digital initiatives.

A good point in the following article is also the contradiction of the new GDPR regulation with the integrity of drug development data:

http://www.pmlive.com/pharma_intelligence/A_new_era_of_smart_pharma_1220658
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FDA to Require GCP Compliance for Device Trials That Rely on Foreign Clinical Data

https://lnkd.in/gYSzvRn
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An ethical review by a single IRB yields important benefits with respect to efficiency, high quality, and consistency in human research protections. Find out why:

http://www.appliedclinicaltrialsonline.com/single-irb-review-all-multicenter-clinical-trials
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ICH Management Committee endorsed a Pilot Training Programme for 2017 that includes 6 high quality courses in Germany, USA, Japan and Singapore. See more details here:

http://www.ich.org/trainings/ich-training-pilot-2017.html
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EMA published Annual report of the Pharmacovigilance Inspectors
Working Group for 2016. Check it out, you may find it useful:

http://www.ema.europa.eu/docs/en_GB/document_library/Annual_report/2017/08/WC500233129.pdf
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MHRA GCP Inspectorate has published the Good Clinical Practice inspection metrics for 2015 to 2016. Check here:

https://www.gov.uk/government/statistics/good-clinical-practice-inspection-metrics-2007-to-present
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