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Digital Health and Pharma 4.0
Digital Health and Pharma 4.0
The GXP environment is evolving as digital technologies are increasingly being applied to the development and manufacture of medicines.
Inaugural GCP Laboratories Stakeholder Engagement Meeting (StEM)
On Tuesday 7 May 2019 representatives from trade organisations, professional bodies, non-commercial organisations and other regulators and government functions involved in the analysis of clinical trial laboratory samples were invited to attend the inaugural GCP Laboratories Stakeholder Engagement Meeting (StEM) …
Good Manufacturing Practice/Good Distribution Practice Symposium 2019
The MHRA Good Manufacturing/Good Distribution Practice Symposium will be held in London on the 11 to 14 November and in Glasgow on 26 to 27 November 2019. This post details how to secure your place and provides some information about what each of the sessions will include.
Round Table: The impact of Electronic Health Records on UK Clinical Trials
On 28 October 2019 the GCP inspectorate will be holding a roundtable discussion aimed at suppliers of electronic health records in both primary and secondary care (including commercial and non-commercial developers). This post details how to register your attendance for this event.
MHRA Process Licensing: useful information
Details and links for new licence applications and variations.
Supply chain security: part 1 - introduction
Theft of medicines increases risk to public health - a look at what can be done to improve distribution security standards.
Analytical Quality by Design (AQbD): questions and answers
This month sees the close of the consultation on the application of Analytical Quality by Design to pharmacopoeial standards. We sat down with Peter and Stephen, pharmacopoeial scientists for the British Pharmacopoeia, to discuss why this consultation may prove vital …
Good Clinical Practice Symposium 2019 (non-commercial)
A look at the hot topics relevant to non-commercial sponsors and investigator sites on the agenda for this event on 11 September in Manchester
Falsified Medicines and the supply chain
Sharing experience from recent events to help you safeguard the legitimate supply chain and avoid risks to public health
Electronic health records
Whether investigator site or sponsor, what can be done to ensure EHRs are fit for purpose to make clinical trials the best they can be.
How the implementation of Safety Features progresses 5 months in
The definition of a falsified medicine and how to check that your systems comply