GOV.UK
PIC/S Meetings April 2019
From 8 to 10 April 2019, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) Committee and PIC/S Executive Bureau meetings took place in Geneva, Switzerland.
Good clinical practice
How to manage safety reporting in a blinded trial
Guidance on the unblinding and reporting of serious adverse reactions (SARs) associated with comparator drugs
Risk Adapted Approach – Neonatal Pharmacokinetic Clinical Trial of Ciprofloxacin in Critical Care. Part 2
The benefits of risk assessment in clinical trial planning and how a more proportionate regulatory approach can overcome potential barriers to completing trials
Short format Development Safety Update Report (DSUR) for Type A trials
Not all trials are the same in terms of risk. To support UK sponsors of clinical trials, a substantially simpler and shorter form may be submitted in lieu of a full DSUR, giving a significant time saving.
MHRA GXP Data Integrity Guidance: Part 1 - A GCP Perspective
Clarification on the interpretation and implementation of the GXP DI guidance in the clinical trial setting
Risk-adapted Approach: Neonatal Pharmacokinetic Clinical Trial of Ciprofloxacin in Critical Care - Part 1
Applying risk-adapted approaches – how this worked for a researcher in neonatal trials.
MHRA Laboratories Symposium 2019 ... plus GXP mailbox update
The MHRA Laboratories Symposium will be held on 13 March 2019 at the Novotel in London. Also ... we have recently changed the contact email address for the laboratories inspection group from glp@mhra.gov.uk to gxplabs@mhra.gov.uk
It pays to be compliant!
In a bid to drive improved compliance and to cover the cost of managing more resource-intensive cases, the Inspectorate intends to apply the existing office-based assessment fee more broadly.
Is it really a First in Human trial? Categorising and assessing the risks correctly
All early phase clinical trials have risks associated with them that require mitigation. Following not just the legislation but also all the associated guidance will help in maintaining public safety and the credibility of data.
Dose Escalation - is it GCP compliant?
Dose escalation practices should be the same regardless of whether a clinical trial involves healthy volunteers or patients. Good quality data and sound procedures are vital to ensure the safety of all trial subjects.