Post-Marketing Surveillance

Do you understand the complexity of Post-marketing Surveillance?

5. Oct 2021

3 days course

English

18,000 DKK ex VAT
(app. 2,420 EUR ex VAT)
50% DISCOUNT FOR PUBLIC INSTITUTIONS

Module 4

Summary

This course will help you understand the different aspects of post-marketing surveillance, risk management planning, post-authorization safety studies, and signal management process tools for signal detection, interpretation and handling of findings.

After the course, you will be able to analyze and interpret signals and findings. You will also know how to use and prepare risk management plans, update Summary of Product Characteristics (SPCs), execute recalls, and manage a product life cycle.

The course is offered every 1 1/2 years.

Keywords

  • Pharmacovigilance Legislation and Guidance Documents
  • Signal Management
  • Periodic Safety Update Report (PSUR) and Risk Management Systems
  • Signal Detection
  • Crisis Management
  • Risk Communication
  • Product Life Cycle Management
  • New Transparency Tools

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

  • Doris Irene Stenver
    Course leader
    Independent Pharmacovigilance Adviser
    Unique Advice
  • Janne Malene Kampmann
    Course leader
    Global and EU QPPV, Senior Director, Global Pharmacovigilance
    Lundbeck Pharma A/S
  • Željana Margan Koletic
    Lecturer
    Head of Pharmacovigilance Dept
    Agency for Medical Products and Medical Devices (HALMED)
  • Pernille Grell Nørgaard
    Lecturer
    Principal Safety Scientist
    H. Lundbeck A/S
  • Maurizio Sessa
    Lecturer
    Assistant professor
    Københavns Universitet
  • Malene Duedal Jensen
    Lecturer
    Safety Scientist
    Lundbeck Pharma A/S
  • Anita Vibsig Neutzsky-Wulff
    Lecturer
    Pharmacovigilance Officer
    Lægemiddelstyrelsen
  • Atheline Major-Pedersen
    Lecturer
    Safety Surveillance Principal Specialist at Global Safety
    Novo Nordisk A/S
  • Jesper Hallas
    Lecturer
    Professor in Clinical Pharmacology
    Univerisity of Copenhagen
  • Karsten Lollike
    Lecturer
    Director
    Novo Nordisk A/S - Novo Allé
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. The different aspects of post-marketing surveillance
  2. How to analyze and interpret signals and findings
  3. How to use and prepare risk management plans, update SPCs, execute recalls and manage a product life cycle
  4. How to share knowledge in relation to post-marketing surveillance
  5. How to operate in a dynamic and changing environment

What your company will get

  1. A safety and pharmacovigilance professional who understands the different aspects of post-marketing surveillance
  2. A safety and pharmacovigilance professional who can independently analyze and interpret signals and findings
  3. A safety and pharmacovigilance professional who can provide valuable input to all other team members working with post-marketing surveillance

Course calendar

Starting 5. Oct 2021
5. Oct 2021 9:00-16:00

DAY 1

  • Current pharmacovigilance legislative framework and guidelines
  • Signal management process from a Marketing
  • Authorisation Holder’s (MAH) perspective
  • Tools for signal detection
  • Signal management process from a regulatory authority’s perspective
  • Workshop - Signal detection
6. Oct 2021 9:00-16:00

DAY 2

  • PSUR Guidance
  • PSUR handling and assessment
  • Risk Management Plans (RMPs)
  • Post Authorization Safety Studies (PASS)
  • Pharmacoepidemiology in pharmacovigilance
7. Oct 2021 9:00-16:00

DAY 3

  • Workshop - Crisis Management
  • Crisis management/Product Recalls
  • Executions of a recall
  • Effective risk communication
  • Impact assessment of pharmacovigilance – the PRAC strategy
Practical information

Related exams

4. Nov 2021 10:00-13:00
Go to exam page

Registration

Registration deadline
28. Sep 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.

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)

Doris Irene Stenver
Independent Pharmacovigilance Adviser
Unique Advice
Janne Malene Kampmann
Global and EU QPPV, Senior Director, Global Pharmacovigilance
Lundbeck Pharma A/S

Lecturers

Željana Margan Koletic
Head of Pharmacovigilance Dept
Agency for Medical Products and Medical Devices (HALMED)
Pernille Grell Nørgaard
Principal Safety Scientist
H. Lundbeck A/S
Maurizio Sessa
Assistant professor
Københavns Universitet
Malene Duedal Jensen
Safety Scientist
Lundbeck Pharma A/S
Anita Vibsig Neutzsky-Wulff
Pharmacovigilance Officer
Lægemiddelstyrelsen
Atheline Major-Pedersen
Safety Surveillance Principal Specialist at Global Safety
Novo Nordisk A/S
Jesper Hallas
Professor in Clinical Pharmacology
Univerisity of Copenhagen
Karsten Lollike
Director
Novo Nordisk A/S - Novo Allé

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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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