3rd European Conference on Monitoring the Effectiveness of Risk Minimisation (Pre-Conference training on 22nd)

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3rd European Conference on Monitoring the Effectiveness of Risk Minimisation (Pre-Conference training on 22nd)
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]

Reference

  1. http://www.dsru.org/courses/course-calendar/course/monitoring-the-effectiveness-of-risk-minimisation/
  2. http://www.dsru.org/courses/course-calendar/course/monitoring-the-effectiveness-of-risk-minimisation/

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