Pharmacovigilance Data in Application and Registration

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

26. Oct 2021

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
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Course leader(s) & Lecturers

  • Nanco Hefting
    Lecturer
    Chief Scientific Specialist
    H. Lundbeck A/S
  • Sasha Ann Solow Rahbek
    Lecturer
    Principle Medical Writer
    LEO Pharma A/S
  • Jens Heisterberg
    Lecturer
    VP, Regulatory Policy and Intelligence
    Novo Nordisk A/S
  • Carina Rosenkilde
    Lecturer
    Surveillance Specialist
    Novo Nordisk A/S
  • Eva Bøge
    Lecturer
    Senior Regulatory Project Manager
    Zealand Pharma A/S
  • Emanuel Lohrmann
    Lecturer
    Senior Director
    MorphoSys AG
  • Delphine Saragoussi
    Lecturer

    Evidera
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 26. Oct 2021
26. Oct 2021 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
27. Oct 2021 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

Registration

Registration deadline
19. Oct 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)

Lecturers

Nanco Hefting
Chief Scientific Specialist
H. Lundbeck A/S
Sasha Ann Solow Rahbek
Principle Medical Writer
LEO Pharma A/S
Jens Heisterberg
VP, Regulatory Policy and Intelligence
Novo Nordisk A/S
Carina Rosenkilde
Surveillance Specialist
Novo Nordisk A/S
Eva Bøge
Senior Regulatory Project Manager
Zealand Pharma A/S
Emanuel Lohrmann
Senior Director
MorphoSys AG
Delphine Saragoussi

Evidera

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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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