Maintaining compliance in a changing world and the complementary themes of change management and control ran throughout the various sessions at this event.
A look at the major topics and key themes covered.
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.
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.
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.
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.
Guidance on the unblinding and reporting of serious adverse reactions (SARs) associated with comparator drugs
The benefits of risk assessment in clinical trial planning and how a more proportionate regulatory approach can overcome potential barriers to completing 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.
Clarification on the interpretation and implementation of the GXP DI guidance in the clinical trial setting
In today’s computerised, high-tech pharmaceutical environment, it is worth reflecting on the Clothier report conclusions from 47 years ago.