Introduction to Drug Safety and Pharmacovigilance

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

6 - 8 Jun 2023

or

1 - 3 Nov 2023

On location

English

15,900 DKK ex VAT

(app. 2,138 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.


OTHER COURSE PARTICIPANTS SAY:

"I enjoyed the variety of lectures and the great presenters. The whole experience was very rewarding for me. I loved the structure of topics; it was easy and interesting to follow. I made very useful notes, and I am very sure I will use the provided slides in my future work."

Sabina Kujundzic, Pharm. D., Safety Data Associate, H. Lundbeck A/S 
  


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

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Course leader(s) & Lecturer(s)

  • Mette Philipsen
    Course leader
    Cluster Safety Lead
    Pfizer ApS
  • Søren Troels Christensen
    Lecturer
    Farmakovigilanceinspektør
    Lægemiddelstyrelsen
  • Peter Eriksen
    Lecturer
    Lead Specialist, Safety Scientist
    H. Lundbeck A/S
  • Morten Gaardlykke
    Lecturer
    Head of Regulatory Affairs Denmark & Iceland
    Pfizer ApS
  • Mette Wikkelsø
    Lecturer
    Pharmacovigilance Officer
    Lægemiddelstyrelsen
  • Mette Stie Kallesøe
    Lecturer
    Senior Principal Professional, Deputy QPPV
    LEO Pharma A/S
  • Line Alleslev Larsen
    Lecturer
    Senior Pharmacovigilance Specialist
    KLIFO A/S
  • Laila Trolle
    Lecturer
    Principle Safety Advisor
    LEO Pharma A/S
  • Kishore Saha
    Lecturer
    PV Director
    Zealand Pharma A/S
  • Jeannett Dimsits
    Lecturer
    Partner
    InnoStrat ApS
  • Jannik Nielsen
    Lecturer
    Senior Safety Surveillance Adviser, Global Safety
    Novo Nordisk A/S
  • Helle von der Recke-Heisel
    Lecturer
    Director Drug Safety, Pharmacosmos
    Pharmacosmos A/S
  • Claudia Pierleoni-Nielsen
    Lecturer
    Senior Director, Global Drug Safety & PV
    Genmab A/S
  • Betina Østergaard Eriksen
    Lecturer
    Vice President Safety Surveillance
    Novo Nordisk A/S
  • Berit Nautrup Andersen
    Lecturer
    Lead Specialist - QMS, Training and PV Intelligence
    H. Lundbeck A/S
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 6 Jun 2023
Starting 1 Nov 2023
6 Jun 2023 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
7 Jun 2023 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
8 Jun 2023 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
30 May 2023
Atrium
Lersø Parkallé 101
2100 København Ø
Register
6 - 8 Jun
1 Nov 2023 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 2023 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 2023 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 2023
Atrium
Lersø Parkallé 101
2100 København Ø
Register
1 - 3 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

Examination

There is no examination for this course.

Course leader(s)

Mette Philipsen
Cluster Safety Lead
Pfizer ApS

Lecturer(s)

Søren Troels Christensen
Farmakovigilanceinspektør
Lægemiddelstyrelsen
Peter Eriksen
Lead Specialist, Safety Scientist
H. Lundbeck A/S
Morten Gaardlykke
Head of Regulatory Affairs Denmark & Iceland
Pfizer ApS
Mette Wikkelsø
Pharmacovigilance Officer
Lægemiddelstyrelsen
Mette Stie Kallesøe
Senior Principal Professional, Deputy QPPV
LEO Pharma A/S
Line Alleslev Larsen
Senior Pharmacovigilance Specialist
KLIFO A/S
Laila Trolle
Principle Safety Advisor
LEO Pharma A/S
Kishore Saha
PV Director
Zealand Pharma A/S
Jeannett Dimsits
Partner
InnoStrat ApS
Jannik Nielsen
Senior Safety Surveillance Adviser, Global Safety
Novo Nordisk A/S
Helle von der Recke-Heisel
Director Drug Safety, Pharmacosmos
Pharmacosmos A/S
Claudia Pierleoni-Nielsen
Senior Director, Global Drug Safety & PV
Genmab A/S
Betina Østergaard Eriksen
Vice President Safety Surveillance
Novo Nordisk A/S
Berit Nautrup Andersen
Lead Specialist - QMS, Training and PV Intelligence
H. Lundbeck A/S

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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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