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Supply chain security: part 1 - introduction
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.
What does qualification of suppliers mean to you? Risks to patients and to your business
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)
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
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
Quality Culture: Learning from History
In today’s computerised, high-tech pharmaceutical environment, it is worth reflecting on the Clothier report conclusions from 47 years ago.
Being signed up to the OECD Mutual Acceptance of Data agreement is anything but MAD!
Why it's a good idea for the UK to be part of the OECD MAD framework
Falsified Medicines Directive: Safety Features
Implementation of the FMD safety features in the UK
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.