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Online Live Training Features

All sessions of this unique course online

Live interaction options between the delegates and trainer

Available via mobile, tablet or laptop

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Meet your expert trainers

  • Dr. Gerhard Hager
  • CEO
  • The NCD Company, Austria
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  • Dr. Paolo Rossato
  • Associate Director, PK & QSP Unit, Pharmacology & Toxicology
    Department, Research
  • CSL Behring, Germany
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  • Louise Mawer
  • GXP Auditor and Trainer
  • Mirabilitas Ltd, United Kingdom
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Key topics

Synergies between ADME and Toxicology studies during early drug development

Key regulatory documents & submission of ADME and Toxicology data

Specifics of Advanced Therapies

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

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-inhand 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
Get critical considerations for compliance of Advanced Therapies
Get to the heart of data integrity, and what the regulators mean by it
Understand the concept of a combined ADMEToxicology 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

Ticket

Delegate Fee

from 1396 € Buy

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