Pharmacovigilance Data in Application and Registration

Understand the relationship between pharmacovigilance and the processes of application and registration

22. Mar 2022

2 days course

English

12,300 DKK ex VAT
(app. 1,654 EUR ex VAT)
50% DISCOUNT FOR PUBLIC INSTITUTIONS

Module 6

Summary

This course will help you understand the relationship between pharmacovigilance and the processes of application and registration. We will focus on the areas and phases in drug development processes where the clinical development, registration, and pharmacovigilance units co-operate closely.

 

Keywords

  • Clinical Trial Protocol
  • Clinical Study Report
  • Summary of Clinical Safety and Clinical Overview
  • Post Authorization Safety Studies (PASS)
  • Summary of Product Characteristics (SPCs)
  • Risk Management Plan
  • Evaluation of Applications for New Medicinal Products by Authorities

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

  • Christina Balslev Rindshøj
    Course leader
    Senior Director
    Ozack ApS
  • Marie Aavang Geist
    Course leader
    VP, Head of Clinical Safety and Pharmacovigilance, QPP
    Orphazyme A/S
  • Sabine Straus
    Lecturer
    Chair, PRAC
    EMA - European Medicines Agency
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 relationship between pre-marketing clinical safety and the processes of application and registration
  2. How to analyze the different pre-application tasks related to clinical safety and turn them into an application for marketing authorisation
  3. The application’s implications for post-authorisation pharmacovigilance

What your company will get

  1. A safety and pharmacovigilance professional who understands the relationship between pharmacovigilance and the processes of application and registration
  2. A safety and pharmacovigilance professional that can independently analyze the different pre-application tasks related to pharmacovigilance
  3. An employee who can play an important role in any interdisciplinary project team
  4. An employee who can provide valuable input on how to improve cooperation between the clinical development, registration and pharmacovigilance units

Course calendar

Starting 22. Mar 2022
22. Mar 2022 9:00-16:00

DAY 1

  • Clinical trial protocol
  • Handling of safety data during a clinical trial
  • Clinical study report with specific focus on the safety sections
  • Clinical documents in application
  • Clinical safety summary
  • Clinical overview
  • Workshop
23. Mar 2022 9:00-16:00

DAY 2

  • Summary of Product Characteristics (SPCs)
  • Preparation for meeting with and presenting to regulatory authorities
  • Regulatory strategy in clinical development
  • The centralized procedure
  • Risk Management Plan (RMP)
  • Risk-benefit framework
  • Post Authorization Safety Studies (PASS)
Practical information

Related exams

27. Apr 2022 10:00-13:00
Go to exam page

Registration

Registration deadline
15. Mar 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.

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

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Course leader(s)

Christina Balslev Rindshøj
Senior Director
Ozack ApS
Marie Aavang Geist
VP, Head of Clinical Safety and Pharmacovigilance, QPP
Orphazyme A/S

Lecturers

Sabine Straus
Chair, PRAC
EMA - European Medicines Agency

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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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