3rd European Conference on Monitoring the Effectiveness of Risk Minimisation (Pre-Conference training on 22nd)
3rd European Conference on Monitoring the Effectiveness of Risk Minimisation (Pre-Conference training on 22nd) | |
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Date | 2016-11-22 |
Place | Boscolo Hotel, Prague |
"This conference is aimed at pharmaceutical industry staff who are new to risk minimisation, as well as those with an established knowledge wishing to pick up new ideas and trouble-shooting tips. The programme will include ample networking opportunities."[1]
Agenda
Tuesday 22nd November – Pre-Conference Tutorial How to design studies for risk management and effectiveness of risk minimisation A workshop for non-pharmacoepidemiologists
0830 - 0900 Registration for delegates
0900 – 0915 Welcome and Introduction Professor Saad Shakir, DSRU
0915 - 1015 How to Design a Risk Management Study Professor Saad Shakir, DSRU
1015 - 1030 Coffee 1030 - 1115 Interactive Session on Designing a Risk Management Study Professor Saad Shakir, DSRU
1115- 1200 Risk Minimisation Methodology as Part of Risk Management David Lewis, Novartis Pharma AG
1200 - 1245 Workshop on Methods of Risk Minimisation Deborah Layton, DSRU
1245 - 1345 Lunch
1345 – 1430 Monitoring the Effectiveness of Risk Minimisation Deborah Layton, DSRU
1430 - 1515 Workshop on Monitoring the Effectiveness of Risk Minimisation Deborah Layton, DSRU
1515 - 1530 Tea 1530 - 1600 Interactive Forum to address outstanding issues
1600 - 1615 Discussion and Summing Up Professor Saad Shakir, DSRU
1615 End of Pre-Conference Tutorial
PROGRAMME – Wednesday 23rd November Chairperson: Professor Saad Shakir
0830 - 0900 Registration for delegates
0900 – 0915 Welcome and Introduction Professor Saad Shakir, DSRU
0915 - 0945 Setting the scene: An introduction and update on risk minimisation Professor Saad Shakir, DSRU
0945 – 1030 Methods of determining effectiveness of risk minimisation measures and selecting the best measure to use Ruth Dixon, GSK
1030 - 1045 Coffee
1045 – 1130 Risk Minimisation for oncology products Anne Kehely, Lilly
1130 – 1300 Forum: Does one size fit all? Divergence of risk minimisation requirements amongst the 28 EU member states. Heike Schoepper , Lesley Wise
1300 - 1400 Lunch
1400 – 1445 Use of electronic healthcare databases as a tool for monitoring the effectiveness of risk minimisation Giampiero Mazzaglia, European Medicines Agency
1445 - 1530 Monitoring the effectiveness of risk minimisation: A pharmacoepidemiological perspective Professor Saad Shakir, DSRU
1530 - 1545 Tea
1545 – 1630 Risk Minimisation case studies and global considerations Lesley Wise, Wise Pharmacovigilance and Risk Management Ltd
1630 - 1700 Discussion
1700 End of day one
1845 Complimentary networking dinner
PROGRAMME – Thursday 24th November Chairperson: Professor Saad Shakir
0900 - 0915 Registration
0915 – 1000 Risk Minimisation: the regulator’s perspective Maarten Lagendijk, Medicines Evaluation Board, The Netherlands
1000 – 1030 Minimisation of Risk in Unmanned Aviation Nigel Breyley, International School of Unmanned & Remotely Piloted Aviation
1030 - 1045 Coffee
1045 – 1130 Lessons from three ongoing global risk minimisation programmes: high risk innovator, biosimilar and orphan medicine Jan Petracek, PharmInvent
1130 - 1215 Open Forum: Unresolved issues
1215 - 1315 Lunch
1315 – 1400 Risk communication and medicines related behaviour Professor Rob Horne, Centre for Behavioural Medicine, School of Pharmacy, University College London
1400 – 1445 The use of WEB-RADR and monitoring social media as a risk minimisation tool Mick Foy, Medicines and Healthcare products Regulatory Agency
1445 - 1500 Tea
1500 - 1530 Risk Minimisation for products in development David Howe, MedImmune
1530 – 1615 Evaluation of effectiveness of risk minimisation measures: case study David Lewis, Novartis Pharma AG
1615 - 1630 Discussion
1630 Close of meeting
[1]
Pre-conference Tutorial:
The workshops were the best part as it enabled a more detailed discussion and was a good opportunity to exchange experiences, Risk Minimisation delegate 2015[2]