| Day 1 - Thursday 18 May 2017 | |||
| 08:00 | Registration | ||
| 08:30 | Welcome and Introduction to the 1st EUFEMED conference (Jan de Hoon, Belgium) | ||
| 08:45 | Keynote: Incidents happen – which lessons can we learn? Jan de Hoon, Belgium | ||
Session 1: Managing risks in early phase clinical trials | |||
| Chairs: Hildegard Sourgens, Germany and Milton Bonelli, UK | |||
| Open forum discussions with competent authority representatives and stakeholders from different EU countries | |||
| 09:15 | The updated EMA guideline on strategies to identify and mitigate risks in First-in-Human clinical trials with investigational medicinal products. Introduction by Ulrike Lorch, UK | ||
| Panel with representatives from EMA and National Competent Authorities / Ethics Committees: Milton Bonelli (UK), François Chapuis (France), Walter Janssens (Belgium), David Jones (UK), Thomas Sudhop (Germany), Kirsty Wydenbach (UK) | |||
| 10:00 | Prevention of over-volunteering in Europe: "How to get a European-wide acceptable system going?" Introduction by Annick Peremans, Belgium | ||
| Panel with stakeholders from different EU countries: Milton Bonelli (UK), Malcolm Boyce (UK), Peter Liedl (Germany), Annick Peremans (Belgium), Barbara Schug (Germany) | |||
| 10:45 | Break | ||
Session 2: Scientific tools in early development of medicines to mitigate risk | |||
| Chairs: Mike Hammond, UK and Yves Donazzolo, France | |||
| 11:15 | Can assessment of CNS target engagement in early development help to minimise risk? Philippe Danjou, France | ||
| 11:40 | Usefulness of physiology-based pharmacokinetics to mitigate risk? An Van Den Bergh, Belgium | ||
| 12:05 | Metabolomics and emerging applications in drug discovery and precision medicine. Elaine Holmes, UK | ||
| 12:30 | Lunch | ||
| 13:15 | Three guided poster tours chaired by Henri Caplain, France and Kerstin Breithaupt, Germany Tim Hardman, UK and Yves Donazzollo, France Luc van Bortel, Belgium and Hildegard Sourgens, Germany | ||
Session 3: Innovative methods and imaging techniques in early medicines development – oral presentations from selection of submitted abstracts | |||
| Chairs: Luc Van Bortel, Belgium and Henri Caplain, France | |||
| 14:00 |
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| 14:15 |
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| 14.30 |
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| 14.45 |
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| 15.00 |
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| 15:15 | Break | ||
Session 4: Examples of innovation and risk management | |||
| (Session organized by the AHPPI) Chairs: Elizabeth Allen, UK and Stuart Mair, UK | |||
| 15:45 | Integrated protocols: from First-in-Human to Proof of Concept. Jorg Taubel, UK | ||
| 16:05 | Toxicity and dose escalation: progression rules in integrated protocols. David Jones, UK | ||
| 16:25 | Innovative in-vitro models of toxicology assessments Christopher Goldring, UK | ||
| 16:45 | Examples of innovation and risk management: perspective from university and industry. Alan Boyd, UK | ||
| 17:20 | Session summary and close | ||
| 17:30 | End of Day 1 | ||
| 19:30 | Reception and conference dinner at the Museum of London | ||
| Award ceremony for the best oral presentations and best posters. | |||
| Day 2 - Friday 19 May 2017 | |
Session 5: Assessment and mitigation of risk in modern development strategies for pediatrics | |
| Chairs: Ingrid Klingmann, Belgium | |
| 09:00 | Microdosing: an opportunity for safer drug development in children? Saskia De Wildt, The Netherlands |
| 09:25 | Oxford Debate: Optimising PIPs through knowledge integration Introduced and moderated by Ingrid Klingmann, Belgium Motion: "Paediatric medicines development should be limited to pharmacokinetic bridging trials." |
| For the motion: Claire Ambery, UK Against the motion: Christoph Male, Austria | |
| 10:15 | Break |
10:45 | Parallel workshops: |
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| 12:15 | Lunch |
Session 6: Assessment and mitigation of risk in trials with biologicals | |
| Chairs: Barbara Schug, Germany and Jean-Louis Pinquier, France | |
| 13:50 | Keynote lecture on immuno-oncology - "How it all got started…" Christian Blank, The Netherlands |
| 14:15 | How to monitor and mitigate immunotoxicity during early phase clinical trials in oncology? Ioannis Karydis, UK |
| 14:40 | How to monitor and mitigate immunotoxicity during early phase clinical trials in inflammatory disease? Ann Gils, Belgium |
| 15:05 | How to monitor and mitigate immunogenicity during early phase clinical trials? Geoff Hale, UK |
| 15:30 | Panel discussion |
| 15:55 | Closing remarks (Hildegard Sourgens, Germany) |
| 16:00 | End of conference |
Preconference 1-day workshop: 17 May 2017
Practical aspects of assessing and mitigating risk in early phase clinical trials
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