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Toxicology for Non-Toxicologists
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Toxicology for Non-Toxicologists

Register Your Interest

This course is currently not scheduled however it can be delivered for your team. To register your interest, complete the form below

Register Your Interest

 

Register your interest in the course. When we schedule dates, we will be in touch.

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Learn more about the course by toggling through the tabs below. Scroll down to view the agenda, trainer info and who should attend.

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

What is Included in a Live Online Course?

 

  • Direct access to an expert trainer.
  • Interactive and engaging sessions with exercises and discussions.
  • Bitesize learning.
  • Access to the Educo Life Sciences Training Portal.
  • Unlimited access to the recordings for 4 to 5 weeks after the last session.
  • A reinforcement session delivered 4 to 5 weeks after the course (online) providing you with extra time with the trainer.
  • A validated certificate of attendance is available for you to download.

Course Dates

 

Find out when this course is running so you can plan your training. Scroll down to view the full agenda.

Dates TBC

1 Week Live Online Training
Register at the top of the page.

Group Discount

 

If you want to train a small group, we offer a group discount between 5% and 50% depending on the course and number of attendees.

 

For a quote, complete our contact form by following the link. Get in touch.

Customised Team Training

 

We also design and deliver fully customised team training focused on your products, processes, technologies and challenges. This is ideal for specific training requirements or larger groups. Please get in touch with us for more information.

 

For more information, complete our contact form by following the link. Get in touch.

Free Online Module

 

  • Module 1 is free to attend and delivered online at a date 3 to 8 weeks before the full course start date.
  • To register for module 1, please submit your details in the form located in the agenda.
  • Module 1 is recorded so if you are unable to attend, you can catch up ahead of the course start date.

 

Full Course Information and Pricing

 

  • To attend the full course, you must register online at the top of the page by selecting the course dates from the drop-down and clicking enrol to add the course to your basket. Once added, please follow the checkout instructions to pay via credit card or bank transfer.
  • There are price tiers for this course. The dates of these are located above. The earlier you register the more you save.
  • The full training course is delivered either online or in a classroom. Please check which course format you have booked.
  • For hybrid training – In the event we do not have enough people on one of the options we will contact you to discuss switching.
  • For live online courses – The dates and times of modules/sessions are subject to change.
  • For live online courses – The module/session durations are approximate.

 

Frequently Asked Questions (FAQs)

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
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