TRAINING

Toxicology, ADME & Early Drug Development Plan

Building an Integrated Safety Testing Strategy based on ADME and Toxicology

12 - 13 March 2020
Holiday Inn Amsterdam Arena Towers

Day

Hour

Minute

Second

Quality standards during Early Drug Development

Early Drug Development Plan – studies and critical milestones

First human dose prediction

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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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DO YOU NEED A TRAINING CUSTOMIZED TO YOUR NEEDS?

Based on your specific needs and goals, we will build a training program that will equip your employees with the right set of skills and practical knowledge to achieve your organization's targets.