...if you can take a few minutes to complete the survey available at the link below, which will be open until 20 November 2017: https://www.surveymonkey.co.uk/r/W2SVP99 Don’t miss the next post,...
...posts will look in greater detail at the licence holder’s responsibility to appoint a suitable RP. References and Notes: Gold Standard: Responsible Person Medicinal Products http://www.thegold-standard.co.uk/job-details/?jobid=297 Rules and Guidance for...
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...
...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...
...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...
...covering the following topics: Electronic Health Records (eHR) Oversight of IMP Investigator Responsibilities Conducted by Third Parties Electronic Patient Reported Outcomes (ePRO) Safety Reporting for Non-Commercials GCP Labs Visit www.mhragcp.co.uk...
...also making careful preparations for a safe return to normal UK on-site inspection scheduling. During the past few weeks we have been engaging with industry trade associations and the NHS...
...will involve organisations being asked to provide electronic copies of documents and other information for review off-site, with teleconferences and email to follow up. Where necessary, the on-site portion of...
...it relates to. 4. Be specific about which company/site a query relates to It helps us to know which site a query relates to. Several companies operate at different site...
