Toxicology for Non-Toxicologists

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  • Individual/Group
  • Individual
  • Group or Team

If you would like training for yourself or a group, complete the form above

Course Overview

 

Those involved in drug development should be aware the toxicology requirements for marketing approval. A range of toxicity studies are required such as general toxicity, toxicokinetic and nonclinical pharmacokinetic, reproduction toxicity, genotoxicity. Other studies are also required if the drug is intended for long use or it is a biologic.

 

This training course will help you understand the jargon and be able to effectively communicate with toxicology colleagues. In addition, the course will describe the basics of toxicology, so you understand the content of a toxicology report. This will be also accomplished with dedicated case studies during the course to optimise learning.

 

With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. Learn more about how we deliver live online training.

 

Key Learning Objectives

 

  • Understand the principles of practical toxicology
  • Examine the role of toxicology in the different phases of drug development
  • Discuss toxicology regulatory requirements to ensure compliance
  • Review the main toxicology studies and related disciplines
  • Definition and role of “toxicokinetics”
  • Description the concept of “safety margins”
  • Practical case studies
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.

This course is aimed at anyone who interacts with toxicology data but does not require specialist knowledge in the field.

 

Relevant departments include:

  • Regulatory Affairs
  • Research & Development
  • Preclinical Development
  • Licensing & Business Development
  • Clinical Operations
  • Clinical Pharmacology
  • Business Development
  • Project Leaders

 

Free First Module and Pricing
  • Module 1 is free to attend for this live online course and is delivered a few weeks before the start date.
  • To enrol onto module 1, please submit your email at the top of the page.
  • All sessions are recorded. If you are unable to attend module 1, you can catch up ahead of the course start date.
  • You will receive a Super Early Bird discount if you purchase the course before module 1.
  • If you decide to purchase the course after module 1, but before the start date you will receive an Early Bird Discount.
  • To sign up to the free first module provide your email address in the form at the top of the page

Frequently asked questions (FAQs)

 

 

 

Could your team benefit from this course?

We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.

For more information you can email us at [email protected] or call +44 (0) 203 111 7357.

Or please summarise your objectives by completing the form below.

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• The training course is delivered either online or in a classroom. Please check which course format you have booked.
• For live online courses, dates and times of modules are subject to change
• Please contact us for the module dates of future deliveries.
• For live online courses, module durations are approximate.