Toxicology Training Courses: Beginners Guide to Toxicology

About the Course

The non-clinical safety assessment for marketing approval of a pharmaceutical product usually includes pharmacology studies, general toxicity studies, toxicokinetic and non-clinical pharmacokinetic studies, reproduction toxicity studies, and genotoxicity studies. For biotechnology-derived products, appropriate non-clinical safety studies should also be conducted on a case-by-case basis. Non-clinical safety studies and human clinical trials should be planned and designed to represent an approach that is scientifically and ethically appropriate.

In toxicology, it should be possible to distinguish expected pharmacology (related to the mechanism of action of the drug) from unexpected or abnormal pharmacology. It should also be possible to rank molecules based on their intrinsic toxic potential and to identify potential adverse effects. These effects should be correlated in toxicology with exposure to assess the presence of a dose-response. Overall toxicology studies should allow the extrapolation from non-clinical data of the human situation. This will allow the inclusion of suitable assessments during clinical development to ensure that the safety of the enrolled subjects (either healthy volunteers or patients) is maintained.

Who Will Benefit

Our toxicology training courses are beneficial to everyone involved in drug development.

• Clinical research associates
• Medicinal chemists
• Pharmacologists
• Toxicologists
• Project managers
• Business development managers
• Medical writers

Key Learning Objectives

• Learn the principles of practical toxicology
• Understand the role of toxicology in the different phases of drug development
• Learn the principles of regulatory toxicology
• Main toxicology studies and related disciplines
• Understand the definition and role of “toxicokinetics”
• Toxicology terminology
• Understand description concept of ‘safety margins’
• Gain insights through practical case studies

Course Information

Instructional Delivery Method: Schedule Digital
Prerequisite & Advanced Preparation: Reading material will be sent prior to the course

Delivered by Dr. Stefano Persiani

Dr. Persiani is currently Director of Translational Sciences and Pharmacokinetics at Rottapharm Biotech, Italy. After years working in academia, Dr. Persiani moved to the pharmaceutical industry and CRO sector holding different positions in R&D at Farmitalia Carlo Erba, Pharmacia, Upjon, and Zambon Group.

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