Training - ISoP Symposium & Training

ISoP-DSRU Mid-Year
Training Course
10-11 May 2022

Webinar


Beyond spontaneous reporting: integrating data from multiple sources to ensure medicines safety

ISoP-DSRU Mid-Year Symposium 2022

Co-ordinator: Rebecca Chandler (ISoP Vice-President).

It was with great excitement that ISoP joined forces with the Drug Safety Research Unit in Southampton to organise our yearly Mid-Year Symposium.
This event was conducted online on May 10 and May 11.

The DSRU is an independent unit which monitors, studies, and communicates about the safety and risk management of medicines.  It has been a leader in the area of pharmacovigilance for over 30 years, evolving over that time to use of a variety of methods and data sources to conduct a wide range of studies.

The practice of pharmacovigilance has long relied on spontaneous reporting systems, and it is clear that the value of these systems remains.  However, new technologies have allowed for the generation of large amounts of data, and innovations in data science have made new approaches to signal detection and risk characterisation possible.

This webinar aimed to engage all interested pharmacovigilance professions from an industry, regulatory, or university setting.  Training certificates were provided by e-mail to those who completed the training.

The symposium was centered around the following themes:
– Maximising the potential of established sources in pharmacovigilance: spontaneous reporting systems and observational studies
– The challenges of leveraging safety data from clinical trials
– Contributions from the world of pharmacogenomics
– Integrating safety data to meet the needs of different stakeholders
– Different approaches to inform on COVID-19 vaccine safety
– Big data in pharmacovigilance

Presentations had been invited from speakers with different professional roles from the global community of pharmacovigilance.

At the end of the Symposium, participants were expected to have acquired an appreciation of the variety of data sources available in pharmacovigilance and an understanding of how each can be leveraged to contribute to the practice of ensuring medicines safety.

The Symposium was awarded 11.75 CPD credits by the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom.

May 10 09:00 - 17:30 UTC+1
Session 1A Causality- complexities and challenges
Session 1B Maximising potential of established sources in pharmacovigilance: spontaneous reporting systems and observational studies
Session 1C The challenges of leveraging safety data from clinical trials
Session 1D Contributions from the field of pharmacogenomics
May 11 09:00 - 16:00 UTC+1
Session 2A Integrating safety data to meet the needs of different stakeholders
Session 2B Real-world data to inform on the safety of the COVID-19 vaccines
Session 2C The use of big data in pharmacovigilance

Programme

Click here to view the final programme.