Preclinical and Clinical Aspects of Pharmacovigilance

Learn about preclinical safety studies and safety monitoring in clinical phase I, II and III studies
15 - 17 Nov 2022

On location

English

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

Summary

This course will help you understand the clinical aspects of pharmacovigilance in support of clinical trials, as well as the data support offered from the 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 understand what preclinical studies and data are created to support pharmacovigilance and how this data may be interpreted. You will be able to analyse the different application tasks related to preparing clinical trial study protocols, principles of safety reporting in clinical trials, i.e. adverse events, SUSARs, annual safety reports, and scientific advice in relation to the preparation of clinical trial applications (e.g. endpoints, statistical power, and safety parameters) as well as the pre-application tasks related to conducting clinical studies.


OTHER COURSE PARTICIPANTS SAY:

"It was a very good course. Well-prepared and with good lectures. It gives a good understanding of the pre-cinical phase which is relevant for assessing data when working in PV." 

Dorte Engebjerg, Global Pharmacovigilance, Ferring Pharmaceuticals


Keywords

  • Pre-clinical Safety Studies
  • Drug Development
  • Clinical Safety Studies
  • Risk Assessment
  • Pharmacovigilance in Clinical Trials
  • Drug Safety
  • Regulatory Affairs
  • Health research ethics

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 

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Course leader(s) & Lecturer(s)

  • 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
    PhD, Principal Specialist
    Novo Nordisk A/S
  • Karin Sørig Hougaard
    Lecturer
    Senior Research Scientist, Affiliate Professor in Reproductive Toxicology
    National Research Centre for the Working Environment
  • 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
  • Dorte Jarmark
    Lecturer
    Senior Event Adjudication Professional
    Novo Nordisk A/S
  • Jette Buch Østergaard
    Lecturer
    Specialist, Clinical Pharmacology
    H. Lundbeck A/S
  • Karina Phonekeo
    Lecturer
    Senior Safety Surveillance Adviser
    Novo Nordisk A/S
  • Lone Fjord-Larsen
    Lecturer
    Senior Director, Nonclinical Development
    Hoba Therapeutics ApS
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 performed. What preclinical data is available to support safety assessments. How this data may be interpreted
  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 to share and discuss knowledge on preclinical and clinical aspects of pharmacovigilance from medical and ethical points of view

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 clinical safety assessments
  2. A safety and pharmacovigilance professional who understands the relationship between pharmacovigilance and the processes of submission of clinical trials applications to health authorities and ethics committees.
  3. A safety and pharmacovigilance professional that can independently analyse 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 is held online, usually 4-6 weeks after the course.

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

 In order to participate in the exam, you must have attended the course.

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

Lecturer(s)

Mikael Elander
Senior Toxicologist
Zealand Pharma A/S
Henrik Friberg-Johansen
Principal Toxicologist
H. Lundbeck A/S
Morten Laursen
PhD, Principal Specialist
Novo Nordisk A/S
Karin Sørig Hougaard
Senior Research Scientist, Affiliate Professor in Reproductive Toxicology
National Research Centre for the Working Environment
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
Dorte Jarmark
Senior Event Adjudication Professional
Novo Nordisk A/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
Jette Buch Østergaard
Specialist, Clinical Pharmacology
H. Lundbeck A/S
Karina Phonekeo
Senior Safety Surveillance Adviser
Novo Nordisk A/S
Lone Fjord-Larsen
Senior Director, Nonclinical Development
Hoba Therapeutics ApS

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Want to know more or need help?

Contact Educational Programme Leader Lone Rex at +45 20 62 11 46

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