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  • Pharma
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Toxicology, ADME & Early Drug Development Plan

“Building an Integrated Safety Testing Strategy based on ADME and Toxicology”
  • 23 - 24 March 2023
  • Rome, Italy | Online Live Stream 9:00 CET – 17:00 CET
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Toxicology, ADME & Early Drug Development Plan

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Training features

Interactive discussions and Q&A sessions
Individual discussion & consultancy with the trainer

Case studies from the trainer's experience
Certificate of completion issued by the trainer
Comprehensive course documentation
Fully online

All sessions of this unique course also online

Live interaction

Live interaction options between the delegates and trainer

On any device

Available via mobile, tablet or laptop

meet the training leaders
Dr. Gerhard Hager | Fleming
Linkedin
Dr. Gerhard Hager
CEO
The NCD Company, Germany
View trainer bio
Dr. Paolo Rossato | Fleming
Linkedin
Dr. Paolo Rossato
Associate Director, PK & QSP Unit, Pharmacology & Toxicology Department, Research
CSL Behring, Germany
View trainer bio
Louise Mawer | Fleming
Linkedin
Louise Mawer
GXP Auditor and Trainer
Mirabilitas Ltd, UK
View trainer bio
training

Brochure

Reveal the full schedule of the training as well as key topics, course objectives, key takeaways, special features, and the trainer bio!

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Toxicology, ADME and Early Drug Development Plan online live training Fleming Agenda cover
Toxicology, ADME and Early Drug Development Plan online live training Fleming Agenda cover
Toxicology, ADME and Early Drug Development Plan online live training Fleming Agenda cover
key training

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

First human dose prediction

Quality standards during Early Drug Development

Early Drug Development Plan – strategy, design and critical milestones

Key regulatory documents & submission of ADME and Toxicology data

Benefits of attending

  • Develop your skills learning how to integrate early ADME and safety studies 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
  • Get a cross functional understanding of the drug development process
  • 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 to the heart of data integrity, and what the regulators mean by it
  • 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
Registration

Training ticket

Delegate Fee
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2396€
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Online Live Stream
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1496€
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Contact us

Andrea Weber | Marketing Manager | Fleming
Linkedin
Andrea Weber
Sr. Manager for Pharma
Phone: +421 257 272 100
Email: event.inquiries@fleming.events

DOWNLOAD THE BROCHURE AND REVEAL THE FULL PROGRAM DETAILS

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