- 07/03/2019 - 08/03/2019
- Vienna, Austria Mercure Hotel Wien City
Meet your prominent trainers
- Dr. Gerhard Hager
- CEO
- The NCD Company, Austria
- Dr. Paolo Rossato
- Associate Director, PK & QSP Unit, Pharmacology & Toxicology
Department, Research - CSL Behring, Germany
- Louise Mawer
- GXP Auditor and Trainer
- Mirabilitas Ltd, United Kingdom
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
Mercure Hotel Wien City
CONTACT US
- Andrea Weber
- Sr. Manager for Pharma
- Phone: +421 257 272 232
- Email: event.inquiries@fleming.events