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| home > white papers > EU GDP Guidelines: Implications for Shipping Clinical Materials into the European Market - PCI Pharma Services |
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 WHITE PAPERS |
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PCI Pharma Services
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EU GDP Guidelines: Implications for Shipping Clinical Materials into the European Market
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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.
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News and Press Releases |
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Destiny Pharma appoints MedPharm to develop new XF-platform drug formulations
Destiny Pharma, a clinical stage biotechnology company focused on the development of novel antimicrobial drugs, is pleased to announce that it has appointed MedPharm as its expert partner to develop new topical formulations of the Company’s novel XF-platform compounds. These new treatments for dermal and ocular infections are part of its second clinical programme to address the global problem of anti-microbial resistance (AMR). MedPharm is a world leading contract provider of topical and transdermal product design and formulation development services using sophisticated in vitro models to de-risk development programmes.
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White Papers |
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Recommendations Sourcing Human Biospecimens
BioIVT
The foundations for protecting human research subjects come from the
ethical principles surrounding the Belmont report : Respect for persons,
beneficence, and justice. The use of human biospecimens in research
supports these principles with legal and ethical regulations - the most
important of which is permission.(1) This permission may come directly
from the donor or granted by others with authorization to protect the
interests of biospecimen donors.
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Industry Events |
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Clinical Innovation Partnerships
11-12 September 2019, Hotel Palace, Berlin
Clinical Innovation Partnerships is the only event for senior clinical operations and
procurement professionals driving innovation in their clinical trials. It is where the
pharma, CRO and vendor clinical trials ecosystem meet to drive innovation in
digitalisation, tech and partnering to improve patient experience and reduce trial
cost and time.
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