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Toxicology, ADME & Early Drug Development Plan

Building an Integrated Safety Testing Strategy based on ADME and Toxicology

  • 07/03/2019 - 08/03/2019
  • Vienna, Austria

Meet your prominent trainers

  • Louise Mawer
  • GXP Auditor and Trainer
  • Mirabilitas Ltd, United Kingdom
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Key topics

Synergies between Absorption, Distribution, Metabolism and Excretion (ADME) and Toxicology studies from Lead optimization to First In Human Studies

From Good Research Practice to Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) & Good Distribution Practice (GDP)

Group Workshop: Design of an early development plan from Lead optimization to First In Human Studies

Quality standards for ADME and toxicologial testing

Key takeaways

Understand

• The concept of a combined ADME-Toxicology approach in preclinical development

• The different ADME and Toxicology Approaches in the development of small molecules and biologics

• Stage specific management of quality in early preclinical development

• Differences between the GXPs and what this means in practice

• The requirements for outsourcing during early drug development

Learn

• To integrate early ADME and Tox- screens into Lead optimization and Early Drug Development

• How science and compliance must go hand-in-hand throughout the drug development processes

• To improve the predictability of safety testing by integrating ADME data

• Basic expectations of GRP, GLP and GCP and how these fit with other regulatory requirements

Gain

• Self-confidence in building an Early Drug Development Plan

• Understanding of the importance of an integrated approach to drug development issues

• An appreciation of audit trails: the need to keep clear records from which studies, actions and decisions can be reconstructed

Training features

Full 2-Day intensive training course

Interactive learning approach

Group Workshop & Exercises

Case Studies from the trainers’ experience

8 H+ of Networking with industry peers

All delegates will receive comprehensive course documentation for use during the program

Certificate of Attendance issued by our Trainers

REGISTRATION

Delegate Fee

from 2396 € Buy

CUSTOMIZE THIS TRAINING TO YOUR COMPANY NEEDS

Based on your requirements, we will build a practical training including content tailored to your specific needs, our cutting edge methodologies and relevant modules from our training portfolio.

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JOIN US IN Vienna

Besides being the capital and largest city in Austria, Vienna is also the cultural, political and economic center of the country. Vienna host many international organizations and is considered to be one of the best places for innovation.

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