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    • Safety Information from a GCP Perspective

       

      On Friday, 22 September 2017, a GCP/GPV training day was held with the subject: “Safety Information from a GCP Perspective“.

      The day started with a presentation on “Core concepts in pharmacovigilance auditing” by Marielle Keulen, Xendo. It was followed by presentations which covered different aspects of Safety information which included Reference Safety Information (RSI) from Clinical Trial and Post marketing perspectives, presented by Deepti Naik, PRA Health Sciences and Marielle Keulen.

      Pharmacovigilance aspects which one comes across during day to day GCP or during monitoring was presented by Deepti Naik in her presentation “Safety information at investigator sites” hereby linking GCP and GPV. Final presentation for the day was on “Reference Safety Information from a QA perspective” presented by Laurentiu Chitimia, Astellas. The day concluded with a Q&A session with the speakers of the day.

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    • OECD – Environment, Health & Safety News – March 2017

      GLP Guidance documents

      An Advisory Document on Test Itemsis being developed by a drafting group, originally under the leadershipof Canada, and now by the United Kingdom, Denmark (Pharmaceuticals) and Italy. The objective of the document is to consolidate text in existing guidance documents that refer to “test item”, as well as promote a consistent approach for performing characterisation of test items. The first draft of the Document was reviewed at the 28th Working Group meeting in April 2014. After subsequent iterations, the latest draft will be reviewed by the March 2017 meeting of the Working Group. It is anticipated that a revised version will be posted on the OECD’s website for public comment in Q2 of 2017.

      The United Kingdom and Japan (Medical Products) are leading efforts to develop version three of a public web page concerning Frequently Asked Questions (FAQ) raised by testing laboratories about implementation of GLP, along with responses prepared by the Working Group. (Versions one and two of the FAQ are posted on the public site.)
      Version three of the FAQ will include three topics related to whether software programmes developed by outside vendors to support calculations by test facilities using OECD Test Guidelines need to be validated by such facilities, and clarification regarding two issues raised after the publication of the OECD’s Guidance Document No. 16 on the GLP Requirements for Peer Review of Histopathology. The last two issues concern: the retention of correspondence during a peer review of histopathology, and differences of interpretation between a reviewing pathologist and the original interpretation of the study pathologist. The Working Group is reviewing the final draft, and publication is anticipated by Q1 or Q2 2017.
       

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    • No 18: The Relationship between the OECD Principles of GLP and ISO/IEC 17025

      Op 2 Sep 2016 is er een nieuwe Position Paper van de OECD SERIES ON PRINCIPLES OF GOOD LABORATORY PRACTICE AND COMPLIANCE MONITORING uitgekomen:

      Regarding the Relationship between the OECD Principles of GLP and ISO/IEC 17025 ENV/JM/MONO(2016)47

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    • No 17: Application of GLP Principles to Computerised Systems

      Op 22 April 2016 is een nieuwe Advisory Document of the Working Group on Good Laboratory Practice uitgekomen:

      Application of GLP Principles to Computerised Systems ENV/JM/MONO(2016)13

      dit document vervangt Consensus Document No. 10: The Application of the Principles of GLP to Computerised Systems