Compliance matters

GCP Serious Breaches - the 2018 Edition

Mandy Budwal-Jagait, 24 May 2019 - Compliance matters, Good clinical practice

A look at the recently published 2018 metrics report for GCP serious breaches reported to the MHRA - and what you need to know about reporting a serious breach.

PIC/S Meetings April 2019

Mark Birse, 21 May 2019 - Compliance matters, Events and symposia, Good clinical practice, Good distribution practice, Good manufacturing practice, Good pharmacovigilance practice

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.

What does qualification of suppliers mean to you? Risks to patients and to your business

Peter Brown, 8 May 2019 - Compliance matters, Good distribution practice, Good manufacturing practice

Recent cases of criminal attempts to sell falsified and stolen stock into the legitimate supply chain have exposed weaknesses in some supplier qualification processes. A reminder of what companies need to do to protect themselves, the public and the supply chain.

Introducing the GDP Office Based Evaluation and Risk Assessment programme (OBERA)

Cheryl Blake, 16 April 2019 - Compliance matters, Good distribution practice

Gateway inspections are due to commence spring 2019 as the first stage of a new GDP inspection approach which will allow MHRA to increase its level of oversight whilst reducing the regulatory burden on those companies with a large number of sites which perform reduced or limited levels of GDP activity.

How to manage safety reporting in a blinded trial

Gail Francis and Kirsty Wydenbach, 9 April 2019 - Compliance matters, Good clinical practice

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

Helen Hill, 28 March 2019 - Compliance matters, Good clinical practice

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

Gail Francis and Rosalind Polley, 13 March 2019 - Compliance matters, Good clinical practice

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.