Preclinical and Clinical Aspects of Pharmacovigilance

Learn about preclinical safety studies and safety monitoring in clinical phase I, II and III studies

15. Nov 2022

3 days course

English

18,450 DKK ex VAT
(app. 2,481 EUR ex VAT)
50% DISCOUNT FOR PUBLIC INSTITUTIONS

Module 5  

Summary

This course will help you understand the preclinical and clinical aspects of pharmacovigilance, including preclinical safety studies. You will also learn about decisions for safety margins and first-dose-in-man, safety principles in phase I, II and III studies, and regulations for safety assessments.

After the course, you will be able to analyze the different pre-application tasks related to preparing clinical study protocols, annual safety reports (SUSARs), integrated clinical study reports and scientific advice in relation to the preparation of clinical trial applications (e.g. endpoints, statistical power, safety parameters, etc.) as well as the pre-application tasks related to conducting clinical studies.

The course is offered every 2 years.

Keywords

  • Pre-clinical Safety Studies
  • Drug Development
  • Clinical Safety Studies
  • Risk Assessment
  • Pharmacovigilance in Clinical Trials
  • Drug Safety
  • Regulatory Affairs
  • Communication with Regulatory Authorities

Hi! Do you need help choosing the right course?

We are ready to help you at +45 39 27 60 60 or contact@atriumcph.com

Stay tuned with Atrium's newsletter

Read more

Course leader(s) & Lecturers

  • Allan Dahl Rasmussen
    Course leader
    Director, Head of Regulatory Toxicology & Safety Assessment
    H. Lundbeck A/S
  • Lise Aagaard
    Course leader
    Senior Legal Advisor (PhD) Council of Bioethics & Nat. Committee on Health Research Ethics
    Sundheds- og Ældreministeriet
  • Mikael Elander
    Lecturer
    Senior Toxicologist
    Zealand Pharma A/S
  • Henrik Friberg-Johansen
    Lecturer
    Principal Toxicologist
    H. Lundbeck A/S
  • Morten Laursen
    Lecturer

    Novo Nordisk A/S
  • Karin Sørig Hougaard
    Lecturer
    Senior Research Scientist, Affiliate Professor in Reproductive Toxicology
    National Research Centre for the Working Environment
  • Birgitte Søgaard
    Lecturer
    Chief Scientist
    H. Lundbeck A/S
  • Fida Issa
    Lecturer
    Safety Surveillance Specialist
    Novo Nordisk A/S
  • James Higginson
    Lecturer

    Y-mAbs Therapeutics A/S
  • Andrew Makin
    Lecturer
    CEO
    Andrew Makin Preclinical Consulting ApS
  • Louise Otzen
    Lecturer
    Primary Toxicologist
    H. Lundbeck A/S
  • Jørgen Schützsack
    Lecturer
    Associate Director, Toxicology
    LEO Pharma A/S
  • Dorte Jarmark
    Lecturer
    Senior Event Adjudication Professional
    Novo Nordisk A/S
  • Josephine Rasmussen
    Lecturer
    Safety Surveillance Specialist
    Novo Nordisk A/S
See all

IS THIS COURSE FOR YOU?

Whether you are new to the field or have several years of experience, this programme is relevant if you are a pharmacovigilance professional who wants to improve your knowledge and skills.

What you will learn

  1. Why preclinical safety studies are done and what preclinical data can be used for in safety assessments
  2. The rationale behind dose selection for first-dose-in-man trials and the reasoning behind decisions for safety margins
  3. The principles of safety monitoring in clinical phase I, II and III studies and regulations for the assessment and monitoring of safety issues in clinical studies
  4. How pharmacovigilance units can co-operate with regulatory authorities
  5. How to share knowledge on preclinical and clinical aspects of pharmacovigilance

What your company will get

  1. A safety and pharmacovigilance professional who understands why preclinical safety studies are done and what preclinical data can be used for in safety assessments
  2. A safety and pharmacovigilance professional who understands the relationship between pharmacovigilance and the processes of application and registration
  3. A safety and pharmacovigilance professional that can independently analyze and evaluate the steps in regulating drug safety
  4. A safety and pharmacovigilance professional who can provide valuable input to all other team members working with preclinical and clinical aspects of pharmacovigilance

Course calendar

Starting 15. Nov 2022
15. Nov 2022 9:00-16:00

DAY 1

  • Welcome and introduction 

PART 1 – Non-clinical studies leading to Phase 1 clinical trials 

  • Overview of the non-clinical development of pharmaceutical compounds

  • Pathology – the gold standard in the repeat-dose toxicity studies

  • Genotoxicity – the discipline that covers many areas

  • Safety pharmacology – addressing unwanted pharmacological effects

  • Workshop 1 – Findings prior to going into man

  • Biologics – The same as small molecules?

  • Summery of day 1 and introduction to day 2 
16. Nov 2022 9:00-16:00

DAY 2

  • Introduction 

PART 2 – Non-clinical studies leading from Phase 1 to marketing and beyond. 

  • Reproductive toxicity – the discipline that was started by terrible findings
  • Carcinogenicity – a long-term unwanted side effect

  • Other aspects of toxicological assessment and introduction to the clinical development plan

  • Workshop 2 – Findings during clinical development

PART 3: Safety monitoring and surveillance in Phase I- III clinical trials

  • Safety considerations with respect to FIH 
  • Exam info, summery of day 2 and introduction to day 3 
17. Nov 2022 9:00-16:00

DAY 3 

  • Introduction 
  • Principles of safety in phase III studies 
  • Workshop

  • Safety reporting in clinical trials 
  • Data Monitoring Committee, incl. case study 
  • Event Adjudication Committee 
  • Ethical approval of clinical trials 
  • Kahoot quiz 
  • Evaluation, feedback and goodbye for now  
Practical information

Related exams

15. Dec 2022 9:00-12:00
Go to exam page

Registration

Registration deadline
8. Nov 2022
Atrium
Lersø Parkallé 101
2100 København Ø
Register
15 - 17 Nov
Sometimes things change. This is the expected programme.

Course information

Literature

Prior to the course you will get access to mandatory and optional readings via your personal Atrium log-in.

Please familiarize yourself with the mandatory readings before starting the course.

The mandatory readings are also part of the examination syllabus.

Prerequisites

To enroll in this course, you must have a relevant educational background at bachelor level and, as a minimum, two years of experience in drug safety or pharmacovigilance, or other equivalent qualifications. We consider all applications upon registration.

If you do not fulfill the requirements, you can still apply for the course if you have suitable experience in the pharmaceutical/biological area that would allow you to benefit from the training and enable you to participate actively during the module. Up to 10% of the positions on our course are filled by applicants who have no or limited experience in drug safety or pharmacovigilance. We consider applicants on a case-by-case basis.

Examination

The exam takes place online about 4-6 weeks after the course, and you can access it from any location that suits you.

You receive a link with the exam questions via your personal Atrium log-in.

This course is a part of this programme

Pharmacovigilance Diploma

The demand for qualified pharmacovigilance professionals is high. Become a sought after and highly valued professional by attending our pharmacovigilance training and acquire the Pharmacovigilance Diploma

Read more

Course leader(s)

Allan Dahl Rasmussen
Director, Head of Regulatory Toxicology & Safety Assessment
H. Lundbeck A/S
Lise Aagaard
Senior Legal Advisor (PhD) Council of Bioethics & Nat. Committee on Health Research Ethics
Sundheds- og Ældreministeriet

Lecturers

Mikael Elander
Senior Toxicologist
Zealand Pharma A/S
Henrik Friberg-Johansen
Principal Toxicologist
H. Lundbeck A/S
Morten Laursen

Novo Nordisk A/S
Karin Sørig Hougaard
Senior Research Scientist, Affiliate Professor in Reproductive Toxicology
National Research Centre for the Working Environment
Birgitte Søgaard
Chief Scientist
H. Lundbeck A/S
Fida Issa
Safety Surveillance Specialist
Novo Nordisk A/S
James Higginson

Y-mAbs Therapeutics A/S
Andrew Makin
CEO
Andrew Makin Preclinical Consulting ApS
Louise Otzen
Primary Toxicologist
H. Lundbeck A/S
Jørgen Schützsack
Associate Director, Toxicology
LEO Pharma A/S
Dorte Jarmark
Senior Event Adjudication Professional
Novo Nordisk A/S
Josephine Rasmussen
Safety Surveillance Specialist
Novo Nordisk A/S

You may also be interested in these courses

WANT TO KNOW More or need help?

Contact Client Manager Ida Salicath at +45 39 15 09 46

Send me a message