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06-12-2021 (Online Course)

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Online Course:
Beginners Guide To Toxicology

Learn the principles of practical Toxicology

6 Modules | 6-week online course
6 December 2021 – 14 January 2022

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overview

Key Learning Objectives

  • Learn the principles of practical toxicology
  • Understand the role of toxicology in the different phases of drug development
  • Learn 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

About the Course

The nonclinical safety assessment for marketing approval of a pharmaceutical product usually includes pharmacology studies, general toxicity studies, toxicokinetic and nonclinical pharmacokinetic studies, reproduction toxicity studies, genotoxicity studies.

For drugs that have special cause for concern or are intended for a long duration of use, an assessment of carcinogenic potential is also required. Other nonclinical studies to assess phototoxicity, immunotoxicity, juvenile animal toxicity and abuse liability are conducted on a caseby-case basis.

For biotechnology-derived products, appropriate nonclinical safety studies should also be conducted on case-by-case basis. Nonclinical 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. Toxicity should also allow to rank molecules based on their intrinsic toxic potential and to identify potential adverse effects.

These effects should be correlated in toxicology with the exposure, to assess the presence of a dose-response.

Overall toxicology studies should allow to extrapolate from non-clinical data the human situation. This will allow the inclusion of suitable assessments during clinical development to ensure that safety of the enrolled subjects (either healthy volunteers or patients) is maintained.

In addition, toxicology studies should allow the identification of patients at higher risk of an adverse event that should be excluded for the initial phases of drug development if this is deemed necessary. The course will cover these aspects that are relevant for non-toxicologists involved in drug development.

Who Will Benefit

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

Why Should You Attend

The development of a pharmaceutical product is a stepwise process involving an evaluation of both animal and human efficacy and safety information. The goals of the nonclinical safety evaluation generally include a characterization of toxic effects with respect to target organs, dose dependence, relationship to exposure, and, when appropriate, potential reversibility.

This information is used to estimate an initial safe starting dose and dose range for the human trials and to identify parameters for clinical monitoring for potential adverse effects. Serious adverse events determined in toxicology studies can influence the continuation of drug development. Those involved in drug development should be aware of what are the toxicology requirements for marketing approval. This will allow non-toxicologists to learn the jargon and be able to effectively communicate with colleagues. In addition, the course will describe the basics of toxicology to allow non-specialists to understand the content of a toxicology report. This will be also accomplished with dedicated case studies during the course to optimize learning.

trainer

Dr. Stefano Persiani

Director of Translational Sciences and Pharmacokinetics, Rottapharm Biotech, Italy

pricing

Packages Price
Online Course$1695+GST

Great Savings when you book 4 or more participants! Call us today on 02 9080 4032 or email training@informa.com.au to take advantage of this offer.


Important • Online Course bookings
For Online Course bookings, please read below before proceeding:

  • All delegate registrations must use their own email address to ensure each delegate receives a unique password to join the digital event. You cannot use one email for multiple profiles.
  • If your company is not based in Australia, check the GST box on the next page as you are not required to pay GST.

Benefits of Learning Online

Informa Corporate Learning’s online courses are new digital, interactive and engaging educational experience designed to
maximise learning for professionals with busy schedules and/or small training budgets.

Our online courses are perfect opportunity for busy professionals as they require just 2 hours per week of your time and include an interactive forum for you to ask direct questions about challenges you are facing to expert course leaders.

Modules are released on a weekly basis, so you can pace yourself alongside your peers and you will have access to a
comprehensive set of assets to support your learning such as video content, quizzes and case studies.

Course Outline

6 Recorded Modules each lasting 45 minutes. Plus two recorded case studies.

MODULE 1:

  • Session 1. Objectives and Introduction
  • Session 2. Non-clinical Testing for Medicinal Substances
  • Session 3. Role of Toxicology Studies

MODULE 2 : 

  • Session 4. Toxicology Studies

MODULE 3: 

  • Session 5. Regulations in Toxicology
  • Session 6. Role of Toxicokinetics in Toxicology

MODULE 4 : 

  • Session 7. Toxicological Considerations and Interpretations for
    Different Drug Classes

MODULE 5: 

  • Session 8. In-house vs Contracted out Toxicology Studies
  • Session 9. Toxicological Challenges with Biotechnology
    Products (Biologicals)
  • Session 10. Toxicological Studies with Established Drugs
  • Session 11. Toxicology Limitations

MODULE 6 : 

  • Session 12. Challenges for Toxicologists and Emerging
    Technologies

when & where

06 Dec 2021

Online Course

On-site & in-house training

Deliver this course how you want, where you want, when you want – and save up to 40%! 8+ employees seeking training on the same topic?

Talk to us about an on-site/in-house & customised solution.

contact

Still have a question?

Sushil Kunwar
Training Consultant
+61 (0)2 9080 4395
Sushil.Kunwar@informa.com

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