Post-Marketing Surveillance

Do you understand the complexity of Post-marketing Surveillance?

No available dates

On location

English

19,550 DKK ex VAT

(app. 2,628 EUR ex VAT)

50% DISCOUNT FOR PUBLIC INSTITUTIONS

Summary

Participate 2 for the price of 1: Bring a colleague for the same price and share the learning experience. That way, you'll have the benefit of having a sparring partner when you're back in the office.

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.


Other course participants say

"It's a great course, it keeps its promises regarding the summary and keywords found on Atrium’s website. The presenters are highly engaged and provide interesting points of view."

Katharina Karlsson. Pharmacovigilance Specialist, Viatris A/S


"The course gives you a good overview of signal management, PSUR and RMP which are important tools in PV. It is good to hear the points of view of both the industry and authorities."

Sana Iqbal, Pharmacovigilance Manager, Billev Pharma ApS


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

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Course leader & lecturers

  • Cecilie Freddie Lange
    Course leader
    Manager, Safety Surveillance Oral Semaglutide
    Novo Nordisk A/S
  • Marianne Hald Clemmensen
    Course leader
    Chef, Klinisk Farmaci – Rigshospitalet og Bornholm
    Region Hovedstaden
  • Charlotta Jørgensen
    Lecturer
    Pharmacovigilance physician
    Ferring Pharmaceuticals A/S
  • Emma Stadsbjerg
    Lecturer
    Pharmacovigilance Officer
    Lægemiddelstyrelsen
  • Anette Kirstine Stark
    Lecturer
    MD PHD
    Lægemiddelstyrelsen
  • Maurizio Sessa
    Lecturer
    Assistant Professor of Pharmacoepidemiology
    Københavns Universitet
  • Jo Vibe Tolshave
    Lecturer
    Senior Principal PV Advisor
    LEO PHARMA A/S
  • Per Sindahl
    Lecturer
    Safety officer
    Lægemiddelstyrelsen
  • Hanna Belcik Christensen
    Lecturer
    Pharmacovigilance Officer
    Lægemiddelstyrelsen
  • Anne Steen
    Lecturer
    Safety Surveillance Medical Writing Specialist
    Novo Nordisk A/S
  • Atheline Major-Pedersen
    Lecturer
    Safety Surveillance Principal Specialist, Global Safety
    Novo Nordisk A/S
  • Jesper Hallas
    Lecturer
    Professor in Clinical Pharmacology
    Syddansk Universitet
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 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 a diploma

Diploma in Pharmacovigilance

The demand for qualified pharmacovigilance professionals is high. Become a sought after and highly valued professional by attending our pharmacovigilance training and acquire the Diploma in Pharmacovigilance.

Read more

Course leaders

Cecilie Freddie Lange
Manager, Safety Surveillance Oral Semaglutide
Novo Nordisk A/S
Marianne Hald Clemmensen
Chef, Klinisk Farmaci – Rigshospitalet og Bornholm
Region Hovedstaden

Lecturers

Charlotta Jørgensen
Pharmacovigilance physician
Ferring Pharmaceuticals A/S
Emma Stadsbjerg
Pharmacovigilance Officer
Lægemiddelstyrelsen
Anette Kirstine Stark
MD PHD
Lægemiddelstyrelsen
Maurizio Sessa
Assistant Professor of Pharmacoepidemiology
Københavns Universitet
Jo Vibe Tolshave
Senior Principal PV Advisor
LEO PHARMA A/S
Per Sindahl
Safety officer
Lægemiddelstyrelsen
Hanna Belcik Christensen
Pharmacovigilance Officer
Lægemiddelstyrelsen
Anne Steen
Safety Surveillance Medical Writing Specialist
Novo Nordisk A/S
Atheline Major-Pedersen
Safety Surveillance Principal Specialist, Global Safety
Novo Nordisk A/S
Jesper Hallas
Professor in Clinical Pharmacology
Syddansk Universitet

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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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