Sharing experience from recent events to help you safeguard the legitimate supply chain and avoid risks to public health
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.
The definition of a falsified medicine and how to check that your systems comply
What delegates learned about improving compliance, plus the latest information on this year's event.
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.