...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...
...personal information in comments such as addresses, phone numbers, e-mail addresses or other online contact details, which may relate to you or other individuals do not impersonate or falsely claim...
The process for submitting Annual Safety Reports (ASRs) for Clinical Trials of Investigational Medicinal Products (CTIMP) to the MHRA is changing. From 01 June 2024, ASRs such as the Development...
...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...
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...
...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)...
...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...
...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...
...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...
...been encouraging to see industry stakeholders and regulatory partners adopting a common approach in their own publications and the messages and themes being echoed in online discussions, workshops and conference...
