Introduction to Drug Safety and Pharmacovigilance

Learn the terminology and the basic elements of drug safety and clinical trial safety

2. Nov 2021

3 days course

English

12,300 DKK ex VAT
(app. 1,654 EUR ex VAT)
50% DISCOUNT FOR PUBLIC INSTITUTIONS

Summary

At this course, you will learn the basics about safety and pharmacovigilance in post-marketing surveillance and clinical trials. You will receive a comprehensive introduction to essential terminology and information sources as well as a thorough introduction to why and how clinical trials are performed.

The course also examines regulatory reports such as Periodic Safety Update Reports (PSUR) and Development Safety Update Reports (DSUR), product safety information and signal detection, interfaces with regulatory departments and with quality assurance about pharmacovigilance audits and inspections, and how to prepare for these.
  

Keywords

  • Danish and European Drug Safety Regulations
  • The Danish Health and Medicines Authority
  • The Individual Case Report
  • Electronic Submission
  • MedDRA
  • Clinical Trial Directive 2001/20EC
  • Non-Interventional Trials
  • Risk Management Plans
Read more

Course leader(s) & Lecturers

  • Per Sindahl
    Lecturer
    Safety officer
    UNKNOWN
  • Berit Nautrup Andersen
    Lecturer
    Director, QPPV, Head of Global Safety Standards and Compliance
    Leo Pharma A/S
  • Claudia Pierleoni-Nielsen
    Lecturer
    Senior Director, Head of Medical Safety
    Lundbeck A/S
  • Laila Trolle
    Lecturer
    Pharmacovigilance Scientist
    LEO Pharma A/S
  • Mette Stie Kallesøe
    Lecturer
    Principal Specialist, Inspections & Audits
    Novo Nordisk A/S
  • Mette Wikkelsø
    Lecturer
    Pharmacovigilance Officer
    Lægemiddelstyrelsen
  • Jeannett Dimsits
    Lecturer
    Sr. Director
    Zealand Pharma A/S
  • Line Alleslev Larsen
    Lecturer
    Deputy QPPV
    Leo Pharma A/S
  • Peter Eriksen
    Lecturer
    Pharmacovigilance Specialist
    Klifo A/S
  • Helle Heisel White
    Lecturer
    Director Drug Safety
    Atrium
  • Jannik Nielsen
    Lecturer
    Safety Surveillance Speciality, Signal Management & Digital Health
    Novo Nordisk A/S
  • Kishore Saha
    Lecturer
    PV Director
    Zealand Pharma A/S
  • Morten Gaardlykke
    Lecturer
    Head of Regulatory Affairs Denmark & Iceland
    Pfizer ApS
  • Karsten Lollike
    Lecturer
    Director
    Novo Nordisk A/S - Novo Allé
  • Line Michan
    Lecturer
    Team Manager GCP/GVP inspections
    Danish Health and Medicines Authority
See all

IS THIS COURSE FOR YOU?

This course is relevant if you are new to the pharmaceutical industry or work in an affiliate company and wish to obtain a general understanding of safety and pharmacovigilance, incl. risk management plans, crisis management or audits and inspections. You will also benefit from the course, if you are a pharmacovigilance employee collaborating with clinical development colleagues on e.g. adverse event reporting.

What you will learn

  1. The basic principles and elements of pharmacovigilance
  2. The essential terminology and information sources
  3. How to use best practices in drug safety and pharmacovigilance working processes
  4. How to prepare adverse event reports and the appropriate pharmacovigilance working methods

What your company will get

  1. A safety and pharmacovigilance professional who understands the basic principles and elements of pharmacovigilance
  2. A safety and pharmacovigilance professional who can operate in a dynamic and changing environment
  3. A safety and pharmacovigilance professional who can provide valuable input to all other team members working with drug safety and pharmacovigilance

Course calendar

Starting 2. Nov 2021
2. Nov 2021 9:00-16:00

DAY 1

  • Regulations and guidelines
  • Qualified Person Responsible for Pharmacovigilance’s (QPPV) role and responsibility
  • System master file
  • Handling of Individual Case Study Report (ICSR), including licensing partners and pharmacovigilance (PV) agreements
  • Product safety information
  • Workshop
3. Nov 2021 9:00-16:00

DAY 2

  • Periodic Safety Update Report (PSUR)
  • Clinical development
  • Clinical Trials Directive
  • Non-interventional studies and post-authorization safety studies
  • MedDRA coding
  • Workshop
4. Nov 2021 9:00-16:00

DAY 3

  • Development Safety Update Report (DSUR)
  • Signal detection
  • Crisis management
  • Risk management plans
  • Inspections
  • How to prepare for audits and inspections
Practical information

Registration

Registration deadline
26. Oct 2021
Atrium
Lersø Parkallé 101
2100 København Ø
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

Examination

There is no examination for this course.

Course leader(s)

Lecturers

Per Sindahl
Safety officer
UNKNOWN
Berit Nautrup Andersen
Director, QPPV, Head of Global Safety Standards and Compliance
Leo Pharma A/S
Claudia Pierleoni-Nielsen
Senior Director, Head of Medical Safety
Lundbeck A/S
Laila Trolle
Pharmacovigilance Scientist
LEO Pharma A/S
Mette Stie Kallesøe
Principal Specialist, Inspections & Audits
Novo Nordisk A/S
Mette Wikkelsø
Pharmacovigilance Officer
Lægemiddelstyrelsen
Jeannett Dimsits
Sr. Director
Zealand Pharma A/S
Line Alleslev Larsen
Deputy QPPV
Leo Pharma A/S
Peter Eriksen
Pharmacovigilance Specialist
Klifo A/S
Helle Heisel White
Director Drug Safety
Atrium
Jannik Nielsen
Safety Surveillance Speciality, Signal Management & Digital Health
Novo Nordisk A/S
Kishore Saha
PV Director
Zealand Pharma A/S
Morten Gaardlykke
Head of Regulatory Affairs Denmark & Iceland
Pfizer ApS
Karsten Lollike
Director
Novo Nordisk A/S - Novo Allé
Line Michan
Team Manager GCP/GVP inspections
Danish Health and Medicines Authority

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WANT TO KNOW MORE or need help?

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

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