Pre-Conference Workshops - 15 May 2019

Workshop 1: Trial simulation and basic tools
• Basic principles of physiology-based PK
• Basic principles of modeling and simulation
• Trial simulation for dose prediction of clinical trials of later phases
• Trial simulation for waiving clinical trials:
- Physiology-based PK models replacing drug-drug interaction trials
- Renal and hepatic impairment
- Genetic variations (personalised medicine
- Age groups
• Training software for virtual trials

Workshop 2: Early clinical development of biologics - what is special?
• What is different in PK of biologicals?
• New therapeutic concepts
• ADAs / Immunogenicity
• Operational aspects
• How to approach PD and safety?
• Combined biomarker and drug development

Main Conference - 16 & 17 May 2019 

Programme sessions:
• Current and future options for virtual trials in early medicines development
• Trends and innovation
• The impact of Brexit on early clinical development in Europe
• The changing landscape - how to be prepared
• Guided Poster tours
• Four different break-out sessions each day focusing on the main themes of the conference

Topics will include:
• Virtual Trials in early medicines development (and their consequences)
• The virtual physiological human
• ‘Big data approach’ of toxicology in animal and human
• Automated, adaptive, de novo drug design
• Digital biomarkers (modernised endpoints, mobile technology)
• How to manage repercussions of Brexit on early clinical development
• Phase I trials in patients: new approaches and designs in Oncology
• Multinational, multicenter Phase I trials – operational challenges


Please note that all fees are exclusive of VAT at the prevailing rate.
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