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Meet your expert trainers

  • Dr. Gerhard Hager
  • CEO
  • The NCD Company, Austria
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  • Dr. Paolo Rossato
  • Senior Scientist, Non-clinical Development Drug Discovery
  • Takeda, Austria
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  • Louise Mawer
  • GXP Auditor and Trainer
  • Mirabilitas Ltd, United Kingdom
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Key Topics

Absorption, Distribution, Metabolism and Excretion (ADME) and Toxicology studies from Lead Optimization to application for First-in-Man (FIM) clinical trials

Synergies between ADME and Toxicology studies during early drug development

Key regulatory documents & submission of ADME and Toxicology data

Key Takeaways

Develop your skills learning how to integrate early ADME and tox screens into Lead Optimization and Early Drug Development through practical workshops

Evaluate through discussion and debate how science and compliance must go hand-in-hand throughout the drug development processes

Design a non-clinical Early Drug Development Plan

Improve the predictability of safety testing by integrating ADME data

Understand the basic expectations of Good Research Practices (GRP), Good Laboratory Practice (GLP) and Good Clinical Practice (GCP), and how these fit with other regulatory requirements

Understand the concept of a combined ADME-Toxicology approach in preclinical development

Define and evaluate differences between the GXPs and what this means in practice

Consider the requirements for outsourcing during Early Drug Development

Join us in Amsterdam

Amsterdam is colloquially known as Venice of the North, because of its lovely canals that criss-cross the city, its impressive architecture and more than 1,500 bridges. There is something for every traveller's taste here, whether you prefer culture and history, serious partying, or just the relaxing charm of an old European city.

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