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Digital Health and Pharma 4.0
Digital Health and Pharma 4.0
The GXP environment is evolving as digital technologies are increasingly being applied to the development and manufacture of medicines.
Highlights of the 2018 GCP Symposium and dates for 2019 - don’t miss out!
What delegates learned about improving compliance, plus the latest information on this year's event.
The 2018 Good Distribution Practice (GDP) Symposium
Maintaining compliance in a changing world and the complementary themes of change management and control ran throughout the various sessions at this event.
The 2018 GMP Symposium
A look at the major topics and key themes covered.
GCP Serious Breaches - the 2018 Edition
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
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
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.