15 – 18 October 2017 | ACC, Liverpool, UK
Pre-Conference Training Courses
Sunday 15th October
The pre-conference programme will take place on Sunday 15th October at the ACC, Liverpool.
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.
|9.00 - 09.45||Adverse drug reactions in children: mind the gaps (in the evidence)||Professor Rosalind Smyth (Director of the UCL Institute of Child Health, Honorary Consultant Respiratory Paediatrician at Great Ormond Street Hospital, previous director of MCRN)|
|09.45 - 10.30||Drug safety in children: observational studies & epidemiology||TBC|
|10.30 - 11.00||Regulatory aspects||Angeliki Siapkara, Medicines and Healthcare Regulatory agency (MHRA)
|11.00 - 11.30||Coffee break|
|11.30 - 12.00||Children in early phase clinical trials: state of the art||Sue Tansey Vice President and Global Head for Therapeutic Strategy Quintiles
|12.00 - 12.30||Difficulties in establishing transplacental ADRs (especially for long term cognitive outcomes)||Marco Tuccori
|12.30 - 13.30||Neonatal pharmacovigilance||Mark Turner University of Liverpool and Chair of enpr-EMA network
|13.30 - 15.00||Lunch|
|15.00 - 15.30||Neonates and Neurodisability: a hard to reach population with specific needs||Ruairi Gallagher Consultant Community Paediatrician, Alder Hey Children's Hospital|
|15.30 - 16.00||Application of spontaneous reporting system to evaluate paediatric ADR||Kristina Star Uppsala Monitoring Centre,Sweden|
|16.00 - 16.30||Coffee break|
|16.30 - 17.15||Precision medicine and paediatric pharmacovigilance: intergrating the genomic data into practice||Daniel Hawcutt University of Liverpool|
Pharmacovigilance and social media
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.
|9.00 - 10.00||Drug safety in Social Media: which social media and what kind of information?|
|10.00 – 11.00||Tools for social media data extraction and analysis|
|11:00 - 11:30||Coffee Break|
|11:30 – 12:30||Drug safety in Social Media: Regulatory perspectives|
|12:30 – 13:30||Periodic assessment of drug safety in social media by pharmaceutical industry|
|13:30 – 15:00||Lunch|
|15:00 – 15:45||How to design a study for signal detection in social media|
|15:45 - 16:30||Beyond social media: Web-based signal detection|
|16:30 – 17:00||Practice: articles reading (groups)|
|17:00 – 17:15||Tea Break|
|17:15 - 17:45||Practice: articles discussion (groups)|