Pre-Conference Training Courses

Sunday 15th October

The pre-conference programme will take place on Sunday 15th October at the ACC, Liverpool.

Paediatric Pharmacovigilance

Chairs: Daniel Hawcutt, University of Liverpool and Marco Tuccori, University Hospital of Pisa

The risks posed to children by medicines may be different to adults, as there are significant differences including:

  • Use of off-label and unlicensed medications which have not undergone the safety assessments that would be expected in an adult population
  • Developmental changes (including hepatic enzyme expression, renal function, and body composition) that affect the pharmacokinetics and pharmacodynamics of the drugs used, that vary across childhood
  • Diseases not commonly seen in adult patients (e.g. Duchenne’s muscular dystrophy, Neonatal surfactant deficiency)
  • For chronic diseases, negotiating the transition from child to whom medication is administered to independent adult

For the last 11 years, the EU directive, in conjunction with US laws, have driven forward the inclusion of children in early phase clinical trials of new drugs in which there is a paediatric indication, while regulatory agencies continue to refine their methods for collection of post-marketing surveillance data. However significant questions remain about the optimal methods for collecting ADR data (e.g. from the child or parent?), how to generate data from hard to reach populations within paediatrics, how to make sure early phase trials in children (using patients not volunteers) generate meaningful data, and how to understand the data generated.

This course will present the current Pharmacovigilance approach for the monitoring of drug safety in children, covering the issues raised above, as well as providing an overview of the state of the art from clinical trials to observational studies and spontaneous reporting.


09:00 - 09:45Adverse Drug reactions in children: understanding the evidenceRosalind Smyth, Director of UCL Great Ormond Street Institute of Child Health
09:45 - 10:30Drug safety in children: observational studies & epidemiologyMarco Tuccori, University Hospital of Pisa
10:30 - 11:00Regulatory aspectsAngeliki Siapkara, Medicines and Healthcare Regulatory agency (MHRA)
11:00 - 11:30Coffee break
11:30 - 12:00Children in early phase clinical trials: state of the art Susan Tansey, Vice President and Global Head for Therapeutic Strategy, Quintiles

12:00 - 12:30Difficulties in establishing transplacental ADRs (especially for long term cognitive outcomes)Marco Tuccori, University Hospital of Pisa
12:30 - 13:30Lunch
13:30 - 14:30Neonatal pharmacovigilanceMark Turner University of Liverpool and Chair of enpr-EMA network
14:30 - 15:00Neurodisability: a hard to reach population with specific needs Ruairi Gallagher Consultant Community Paediatrician, Alder Hey Children's Hospital
15:00 - 15:30Discovering new medicine-related problems in paediatric spontaneous reportsKristina Star, Uppsala Monitoring Centre,Sweden
15:30 - 16:00Coffee break
16:00 - 16:45Precision medicine and paediatric pharmacovigilance: intergrating the genomic data into practiceDaniel Hawcutt, University of Liverpool
16:45 - 17:00Wrap-up and Close

Pharmacovigilance and social media

Chairs: Simon Maskell, University of Liverpool, Danushka Bollegala, University of Liverpool and Phil Tregunno, MHRA

The central role of patients in pharmacovigilance was widely demonstrated during the last decade. The efforts made to involve patients in drug safety monitoring activities produced important results. However, it becomes increasingly evident that the traditional approach of ADR reporting, such as paper-based reports, are often inconvenient, slow and inefficient. It is a pervading professional opinion that there is a necessity to explore and utilize new avenues of data collection to improve the efficacy of the system. The rapid development of technology brings with it the opportunity to harvest vast amounts of data, particularly from social media, to allow earlier signal detection, develop early warning systems and enhance pharmacovigilance and patient safety. If data is harnessed correctly, the field of pharmacovigilance could potentially undergo a revolution.

This course is aimed to stimulate the discussion on how monitoring social media with practical experience from different pharmacovigilance stakeholders. This training course will provide knowledge to improve social media periodic screening for safety information in routine office practice in a pharmaceutical industry and/or in a regulatory agency.


08:30 - 09:00Registration
09:00 - 10:00Logistical Considerations of Accessing Social MediaDanushka Bollegala, University of Liverpool
10:00 – 11:00The legal considerations related to data protection as relevant to social media and healthLorna Woods, University of Essex
11:00 - 11:30Coffee Break
11:30 – 12:30Natural Language Processing for Mining Online Health-related DataNigel Collier, University of Cambridge
12:30 - 13:30Lunch
13:30 - 15:00A pharmaceutical industry perspective on the use of social media for pharmacovigilance

A regulatory perspective on the use of social media for pharmacovigilance

A technical perspective on the use of social media for pharmacovigilance
(30 mins) Patrycja Ustach, GlaxoSmithKline

(30 mins) Phil Treguno, MHRA

Danushka Bollegala, University of Liverpool
15:00 – 15:45Workshop
Web interface
Danushka Bollegala, University of Liverpool
15:45 - 16:15Coffee Break
16:15 – 17:15A high-level overview of the state-of-the-artAlistair Willis, The Open University
17:15 - 17:30Wrap-up and close

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Conference Partners
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Phone:+44 161 209 3354