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Now also available via Online live stream!

In the light of the current outbreak of COVID 19 across Europe, we have prepared an option to accommodate those delegates who will not be allowed to travel. The situation might fully be under control by the time when the training is planned to run, however we want to make sure everyone will get the same chance to take part in this unique training course.

Are you going to be able to attend the course in-person? Fantastic! We are looking forward to meeting you. Will you not be allowed to travel or do you feel it is safer to enjoy this unique course from the luxury of your office or home via your laptop, tablet or mobile? We obviously understand the situation and offer you the opportunity to join us via the online live stream enabling the mutual interaction between you and the trainer.

All sessions of this unique course online

Live interaction options between the delegates and trainer

Available via mobile, tablet or laptop

Reveal the full schedule, program, and trainer info!

Download the brochure and reveal the full program details

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

Join us in Basel

Home to 40 museums, the city of culture for connoisseurs has the highest concentration of museums in the country. Basel also has a beautiful Old Town, modern architecture, and the Rhine – an inviting spot to rest a while.

Tickets

Delegate Fee

from 2396 € Buy

Online Live Stream

from 1396 € Buy

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.

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