Pharmacovigilance Systems Master File

Understand the basic principles of pharmacovigilance systems

10. Nov 2021

3 days course

English

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

Module 2

Summary

This course will help you understand the basic principles of pharmacovigilance systems and the organisation of a pharmacovigilance department and its interfaces with other departments. You will also learn about the standard operational procedures in a pharmacovigilance department and the use of and access to databases, how to prepare and follow up on audits and inspections, and how to operate in a highly dynamic and changing environment.

The course is offered every 2 years.

Keywords

  • Pharmacovigilance Systems
  • Interfaces with other departments
  • Standard Operative Procedures
  • Medical Dictionary for Regulatory Activities (MedDRA)
  • Qualified Person for Pharmacovigilance (QPPV)
  • Periodic Safety Update Reports (PSURs)
  • Pharmacovigilance Agreements
  • Inspections and Audits

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

  • Heidi Filtenborg Madsen
    Course leader
    Senior Specialist, QPPV Office
    Lundbeck A/S
  • Wasim Anwar
    Course leader
    Vice President & Deputy QPPVHead of GS Compliance, Global Safety
    Novo Nordisk A/S
  • Elspeth Mcintosh
    Lecturer
    Director
    Castle Pharmacovigilance Limited
  • Ea Holst
    Lecturer
    Director
    PharmaIT
  • Noha Kassem
    Lecturer
    Senior Director
    Eli Lilly, United Kingdom
  • Majken Berghuis
    Lecturer
    Deputy QPPV
    LEO Pharma A/S
  • Åsa Larsson
    Lecturer
    MRC QA, Sr. Area Lead, Pharmacovigilance
    H. Lundbeck A/S
  • Karen Møller Holm
    Lecturer
    Medical Information and Pharmacovigilance Manager, Country Safety Head
    Sanofi Danmark
  • Bina Kramhøft Schack
    Lecturer
    QPPV, GPV, Business Support
    H. LUNDBECK A/S
  • Berit Nautrup Andersen
    Lecturer
    Director, QPPV, Head of Global Safety Standards and Compliance
    Leo Pharma A/S
See all

IS THIS COURSE FOR YOU?

Whether you are new to the field or have several years of experience, this course is relevant if you are a pharmacovigilance professional who wants to improve your knowledge and skills.

What you will learn
 

  1. The basic principles of pharmacovigilance systems
  2. The organisation of a pharmacovigilance department and its interfaces with other departments.
  3. How to analyse and evaluate methods and data in drug safety reporting
  4. How to evaluate regulations and guidelines in pharmacovigilance and pharmacovigilance systems
  5. Best practices in drug safety reporting, including relevant Standard Operating Procedures (SOPs)

What your company will get

  1. A safety and pharmacovigilance professional who understands the principles of pharmacovigilance systems
  2. A safety and pharmacovigilance professional who can independently analyse and evaluate methods and data in drug safety reporting
  3. A safety and pharmacovigilance professional who can analyze and evaluate regulations and guidelines in pharmacovigilance and pharmacovigilance systems
  4. An employee who can play an important role in any project team working with pharmacovigilance systems

Course calendar

Starting 10. Nov 2021
10. Nov 2021 9:00-16:00

DAY 1

  • Introduction to the Pharmacovigilance Systems
  • Master File (PSMF) - structure and management
  • Local PSMF
  • The organizational structure of the marketing authorisation holder
  • Workshop
  • Computerised systems and databases
  • Quality system - procedural documents
  • Pharmacovigilance processes
11. Nov 2021 9:00-16:00

DAY 2

  • Pharmacovigilance system performance
  • Quality system - document and record control
  • Quality system - training
12. Nov 2021 9:00-16:00

DAY 3

  • Audits and inspections
  • Workshop
  • Pharmacovigilance agreements
  • Annexes
  • Qualified Person for Pharmacovigilance (QPPV)
Practical information

Related exams

7. Dec 2021 10:00-13:00
Go to exam page

Registration

Registration deadline
3. Nov 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)

Heidi Filtenborg Madsen
Senior Specialist, QPPV Office
Lundbeck A/S
Wasim Anwar
Vice President & Deputy QPPVHead of GS Compliance, Global Safety
Novo Nordisk A/S

Lecturers

Elspeth Mcintosh
Director
Castle Pharmacovigilance Limited
Ea Holst
Director
PharmaIT
Noha Kassem
Senior Director
Eli Lilly, United Kingdom
Majken Berghuis
Deputy QPPV
LEO Pharma A/S
Åsa Larsson
MRC QA, Sr. Area Lead, Pharmacovigilance
H. Lundbeck A/S
Karen Møller Holm
Medical Information and Pharmacovigilance Manager, Country Safety Head
Sanofi Danmark
Bina Kramhøft Schack
QPPV, GPV, Business Support
H. LUNDBECK A/S
Berit Nautrup Andersen
Director, QPPV, Head of Global Safety Standards and Compliance
Leo Pharma A/S

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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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