Meet your expert trainers
- Dr. Gerhard Hager
- CEO
- The NCD Company, Austria
- Dr. Paolo Rossato
- Senior Scientist, Non-clinical Development Drug Discovery
- Takeda, Austria
- Louise Mawer
- GXP Auditor and Trainer
- Mirabilitas Ltd, United Kingdom
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
Contact us
- Andrea Weber
- Sr. Manager for Pharma
- Phone: +421 257 272 232
- Email: event.inquiries@fleming.events