Introduction to Drug Safety and Pharmacovigilance

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

2. Nov 2021
17. May 2022
1. Nov 2022

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

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) & Lecturers

  • Mette Philipsen
    Course leader
    Cluster Safety Lead
    Pfizer ApS
  • 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
    Principle Safety Advisor
    LEO Pharma A/S
  • Mette Stie Kallesøe
    Lecturer
    Senior Principal Professional, Deputy QPPV
    LEO Pharma A/S
  • Jeannett Dimsits
    Lecturer
    Sr. Director
    Zealand Pharma A/S
  • Line Alleslev Larsen
    Lecturer
    Deputy QPPV
    Leo Pharma A/S
  • Peter Eriksen
    Lecturer
    Pharmacovigilance Specialist
    H. Lundbeck A/S
  • Helle von der Recke-Heisel
    Lecturer
    Director Drug Safety, Pharmacosmos
    Pharmacosmos A/S
  • 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
  • Betina Østergaard Eriksen
    Lecturer
    Vice President Safety Surveillance
    Novo Nordisk A/S
  • Søren Troels Christensen
    Lecturer
    Farmakovigilanceinspektør
    Lægemiddelstyrelsen
  • Doris Irene Stenver
    Lecturer
    Independent Pharmacovigilance Adviser
    Unique Advice
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

Choose your starting date
Starting 2. Nov 2021
Starting 17. May 2022
Starting 1. Nov 2022
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
Sold out
17. May 2022 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
18. May 2022 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
19. May 2022 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
10. May 2022
Atrium
Lersø Parkallé 101
2100 København Ø
1. Nov 2022 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
2. Nov 2022 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
3. Nov 2022 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
25. Oct 2022
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)

Mette Philipsen
Cluster Safety Lead
Pfizer ApS

Lecturers

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
Principle Safety Advisor
LEO Pharma A/S
Mette Stie Kallesøe
Senior Principal Professional, Deputy QPPV
LEO Pharma A/S
Jeannett Dimsits
Sr. Director
Zealand Pharma A/S
Line Alleslev Larsen
Deputy QPPV
Leo Pharma A/S
Peter Eriksen
Pharmacovigilance Specialist
H. Lundbeck A/S
Helle von der Recke-Heisel
Director Drug Safety, Pharmacosmos
Pharmacosmos A/S
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
Betina Østergaard Eriksen
Vice President Safety Surveillance
Novo Nordisk A/S
Søren Troels Christensen
Farmakovigilanceinspektør
Lægemiddelstyrelsen
Doris Irene Stenver
Independent Pharmacovigilance Adviser
Unique Advice

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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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