Pharmacovigilance and Safety Reporting

The MHRA Good Clinical Practice Guide defines pharmacovigilance as ‘the science of collecting, monitoring, researching, assessing and evaluating information on the adverse effects of medicines, with a view to identifying information about potential new hazards and preventing harm to subjects.’  MHRA GCP Guide, 2012.

I’ve had an interest in pharmacovigilance for a number years now, ever since I completed my Masters degree in Clinical Research, where I completed my dissertation on ‘Pharmacovigilance and adverse drug reaction reporting within a central London hospital.’ I later went on to undertake my PhD, investigating the benefit-risk of medicines, and incorporating the patient’s perspective. I submitted my PhD thesis in April 2018 and I still await the viva voce! (Gulp).

During a drug’s lifecycle, evidence must demonstrate that the benefits of the product continue to outweigh the risks. Benefit-risk (B-R) assessment is a vital stage of the drug approval process and is an important task for pharmaceutical companies and regulatory agencies. Medical assessors, pharmaceutical company and regulatory agency personnel, patient advocates and patients are all involved in B-R assessment. My thesis investigated the patient’s perspective and how patients can become involved in the process of B-R assessment, and I found the research incredibly enlightening.

After completing my research, I decided to develop the content into a one day workshop, therefore, Paul Cross Consulting and Siobhan Lim Consulting are pleased to announce the launch, which has now been confirmed for November 2018.

This one-day workshop will cover the principles of pharmacovigilance as well as the reporting requirements for both sponsors and investigator sites. The scientific justification for pharmacovigilance will be described as will the importance of benefit-risk assessment in clinical trials. The workshop is designed for NHS / academic staff whose role involves pharmacovigilance governed by the regulations required for clinical trials of medicinal products. For example, sponsor representatives, investigators, research nurses, trial managers, project managers, QA staff or R&D staff. Management staff who supervise staff responsible for pharmacovigilance reporting, or clinical research staff preparing for GCP audit or GCP inspection, will also find this workshop of interest.

Course objectives

Upon completion of this workshop you will be able to:

  • Define the scientific principles of pharmacovigilance and benefit-risk assessment in clinical trials
  • Describe the requirements of adverse event recording and medical evaluation and assessment
  • Define serious adverse events (SAEs), serious adverse reactions (SARs), and suspected unexpected serious adverse reactions (SUSARs)
  • State the reporting requirements at the investigator site and sponsor level
  • Develop a development safety update report (DSUR)
  • Understand the requirements of EudraVigilance
  • Be aware of the changes to pharmacovigilance legislation and the impact on clinical research
  • State at least 3 examples of non-compliance around adverse event and serious adverse event reporting.


You can find out further information about the course here.










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