...sector, the recent Annex 1 revision, parallel imports, the Defective Medicines Report Centre (DMRC), cannabis-based products for medicinal use (CBPMs) and the British Pharmacopeia (BP). My thanks go to our...
...and implemented once the necessary approvals have been received from the regulatory authority and ethics committee. Reference Safety Information (RSI) update by Medical Assessors Lisa Campbell and Beatrice Panico from...
...on data integrity. The new OECD Data Integrity Advisory Document can be found here: https://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/cbc/mono(2021)26&doclanguage=en The OECD Advisory Document on Data Integrity takes precedence over the MHRA GXP Data Integrity...
...by following the link below: https://www.surveys.mhra.gov.uk/6114d4a2a39326179d39038a The survey will close at midday on Friday 3 September 2021. The date for the GPvP Symposium in 2022 will be confirmed in due...
...you again next year. We will confirm dates and venues for the 2020 event within the next few months so keep an eye on www.mhragmdp.co.uk for details. Don’t miss...
...Inspection may take longer than a single day. The inspector(s) will specifically - but not exclusively - be looking for evidence of the following: all sites named on the WDA(H)...
Q&As clarifying expectations for implementation of the HBEL guide and cross-contamination control requirements from Chapters 3 and 5 were published in April 2018: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2017/01/WC500219500.pdf The Q&As that were published for...
...hosting after the event, which will include select topics from the symposium and be aimed at anyone who is unable to attend the event itself. We would really appreciate it...
