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Introduction to Toxicology

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Date
27.11.24 - 28.11.24
Start time
27.11.24 09:00
End time
28.11.24 17:30
Where
Royal Society of Biology, 1 Naoroji Street, London, WC1X 0GB

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* This course is running over two days, 9:00-17:30 on the 27th November, and 9:00 - 17:00 on the 28th, with breaks.


Overview

A two-day interactive training course presented by two experts in drug development with extensive experience in toxicological testing.

The course is designed to give background and introduction to the variety of disciplines that make up toxicology. Although focussed on pharmaceutical (drug) development, many of the principles presented also apply to other areas, such as agrochemicals and industrial chemicals. 

Toxicological testing is a vital part of the drug development process with studies required to meet legislative requirements, but also for screening out “faulty drugs”, understanding the nature, site and mechanism of action of toxicants, and identifying potential safety signals for clinical use of a drug. Such testing can lead to withdrawal of a drug during development due to no/little safety margin, lack of understanding of a mechanism of toxicity or a clear indication that a lesion has relevance for humans.

Who is the course for?

The background of delegates can vary from business development/sales and related staff in the pharmaceutical industry, through those in other commercial/financial roles to those new to the toxicology testing environment wishing to learn more on its many aspects (e.g., new/trainee Study Directors, laboratory-based staff, analysts, pharmacologists, project leaders etc). 

If you have questions about the suitability of this training, please contact training@rsb.org.uk by the 1st September 2024 with some information on your background.


Objectives

At the end of the course, it is envisaged that delegates will:
  • Have an understanding of the ‘what, how and why' of toxicology (what is toxicology, how is it evaluated and why do we perform toxicology studies?)
  • Be able to decipher toxicology jargon
  • Understand the importance of toxicology throughout the different phases of drug development and clarify interaction with regulatory agencies
  • Appreciate the component parts of toxicology testing and how study packages to support clinical testing are developed
  • Examine alternative testing requirements for different drug product modalities
  • Understand how different types of findings are interpreted in toxicology studies
  • Allow smooth interaction with experienced drug development colleagues


Course Structure

This course comprises the following teaching areas and will allow delegates to show what they have learned with various case studies during each day.

Day 1
  • Toxicology - The Basics plus Toxicology and Risk Assessment
  • Nonclinical Testing for Medicinal Substances including Regulatory Structure, Terminology, Regulatory Guidelines Used by Toxicologists, Toxicology Data Required for Clinical Trials and Marketing Applications plus Toxicology and Clinical Trials
  • Role of Toxicology Studies including Related Disciplines (Safety Pharmacology) and Toxicology Studies
  • Single Dose and Repeat Dose Toxicology Studies
  • Genotoxicity, Reproduction Toxicology and Carcinogenicity Studies plus Other Areas of Toxicology Testing            
  • GLP and Welfare Regulations in Toxicology
  • Toxicology Study Protocol (Plan) and Report and Toxicology “Expert Report” 
  • Role of Toxicokinetics in Toxicology including Toxicokinetics in Toxicology Studies, Toxicokinetic Data plus Toxicokinetics and Starting Dose in Clinical Trials
  • The Toxicologist in the Project Team
Day 2
  • Toxicological Testing of Impurities, Metabolites and Novel Excipients
  • Toxicological Considerations for Anti-cancer Drugs
  • Toxicological Considerations with Biotechnology Products (Biologicals) plus “Grey Area” Modalities
  • Toxicological Considerations with Gene and Cell Therapy Products
  • Toxicological Considerations for Vaccines
  • Toxicological Considerations for Different Dose Routes
  • Toxicology in Action - Findings and Their Interpretation
  • In-house vs Contracted Out Toxicology Studies
  • Toxicological Studies with Established Drugs
  • Value of Toxicology Testing
  • Other Toxicological Evaluation including In Silico, In Vitro, The “omics”, Biomarkers and Microdosing

Course tutors

Dr Guy Healing is a Senior Toxicologist with ApconiX, a pre-clinical consultancy group, where his role focusses on assisting large and small Pharma companies with their drug development and outsourcing activities. Prior to this, he worked for 20 years at AstraZeneca, eventually heading up the Regulatory Submissions Group. He has also worked for the Medical Research Council and Schering Agrochemicals, and lectures at the University of East Anglia, where he has an honorary professorship. 
Guy is a European and UK Registered Toxicologist and a Fellow of the British Toxicology Society.  He has served on the BTS Executive Committee, including an extended spell as their Treasurer, and edited the Society Newsletter for 10 years. He has been an editorial board member for several toxicology journals and has over 40 peer reviewed publications, as well as editing textbooks on preclinical infusion technology. 

Professor Paul Baldrick is Executive Director, Nonclinical Regulatory Strategy within the Product Development and Market Access Consulting group at Fortrea (formerly Labcorp and Covance) and is based in the UK; he has a BSc (1983) and PhD (1988) from Durham University, UK. Professor Baldrick is also Visiting Chair (Regulatory Toxicology) of the Lincoln School of Pharmacy, College of Science, University of Lincoln. His main responsibilities include providing regulatory strategy/nonclinical support for new product development and registration of small molecule pharmaceuticals, biotechnology products, gene and cell therapy products, vaccines and medical devices. Professor Baldrick has well over 30 years of experience in nonclinical development (CRO, UK [Fisons] and Belgium [UCB] industry) with knowledge of the development of many compound classes and regulatory issues/submissions; along with extensive regulatory agency interaction, he has written numerous peer-reviewed publications (over 75) and is a regular podium speaker/chairperson as well as a lecturer on training courses for a range of nonclinical and associated regulatory topics. He is a Fellow of The British Toxicology Society (FBTS) and is on the editorial board of Journal of Toxicology and Toxicology Reports.

Continuing professional development

This course is approved for purposes of CPD. Attendees will receive a certificate of attendance and this course counts for 48 CPD points.

Fees**

** The first 5 bookings are available at an additional 10% off

Members - £700 + VAT
Non-members - £900 + VAT

Get in touch with training@rsb.org.uk to access these rates:
  • Members of Member Organisations, SCAS members - £800 + VAT
  • Non-members who have completed a membership application and made payment - £700 + VAT

Contact

For further information about the course please contact Emily Lunn, training and registers officer at training@rsb.org.uk or on 020 3925 3447.

Special requirements

If you have accessibility requirements, please let us know during your booking, and we will do what we can to accommodate your needs.

Refunds

Unfortunately, the Royal Society of Biology is unable to offer refunds on training courses that have been attended. We do, of course, welcome and encourage any feedback from a course and will continue to improve the service we offer.

Terms and Conditions

By booking to attend this event, you are confirming you have agreed to the RSB's Terms and Conditions which can be found here.