Post Learning Implementation Plan (PLIP)

Pre-course

• Access to the Educo Training Portal
• Submit your needs analysis and objectives for training by completing a simple online form

Action Plan

• At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge

Reinforcement Session

• Delivered 3 to 4 weeks after the training
• It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover and subsequent questions and challenges

Module 1

| 60 mins

Objectives and introduction

• Non-clinical Testing for Medicinal Products
• Role of Toxicology Studies

Module 2

| 90 mins

Toxicology studies detailed

• General toxicity
• Toxicokinetic and nonclinical pharmacokinetic
• Reproduction toxicity
• Genotoxicity
• Carcinogenic potential
• Phototoxicity
• Immunotoxicity
• Juvenile animal toxicity
• Abuse liability

Module 3

| 90 mins

Regulations in toxicology

• Examine the regulatory guidelines for toxicity testing throughout drug development
• Role of Toxicokinetics in Toxicology

Module 4

| 90 mins

Toxicology and drug classes

• Toxicological Considerations and Interpretations for Different Drug Classes

Module 5

| 90 mins

Toxicology special cases

• In-house vs Contracted out Toxicological Studies
• Toxicological Challenges with Biotechnological Products (Biologicals)
• Toxicological Studies with Established Drugs
• Toxicology Limitations

Module 6

| 90 mins

Challenges and future trends in toxicology

• Challenges for Toxicologists and Emerging Technologies

Dr. Stefano 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 always applying pharmacokinetic approaches in R&D at Farmitalia Carlo Erba, Pharmacia, Upjon, and Zambon Group.

His experience within pharmaceutical companies and CROs includes the assessment of pharmacokinetics, drug metabolism, and drug-drug interactions during drug discovery for lead optimization and in preclinical as well as in clinical pharmacology during drug development. He has experience addressing pharmacokinetic issues for drugs and biologics under development in different therapeutic areas including oncology, respiratory, CNS, anti-infective, cardiovascular, gastrointestinal, and rheumatology. In these therapeutic areas, he applies translational, PK/PD prediction, and modelling strategies for candidate selection and to obtain the proof of concept of efficacy and safety in preclinical models as well as during clinical trials in the target patient populations. Dr. Persiani regularly interacts with regulatory authorities and acts as peer reviewer of scientific articles in the field of pharmacokinetics and clinical pharmacology.