Pharmacovigilance Data in Application and Registration

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

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  • 29. Sep 2021

2 days course

English

12.300,- DKK ex VAT
(app. 1.654,- EUR ex VAT)
50% DISCOUNT FOR PUBLIC INSTITUTIONS

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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

Course calendar

Start 29. Sep 2021
Registration deadline 22. Sep 2021
29. Sep 20219:00 - 16:00
30. Sep 20219:00 - 16:00
Atrium
Lersø Parkallé 101
2100 København Ø

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
Available start dates
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Registration quick facts

You can pay by credit card or by invoice. We charge the amount shortly after you register. If you cancel your registration more than 30 days prior to the course, you will receive a full refund. Read our cancellation policy.

Yes, if you experience any technical problems, please call us at + 45 39 27 60 60, or send us an email at contact@atriumcph.com

If you cancel your registration more than 30 days prior to the course, you will receive a full refund. If you get sick and cannot attend the course, you may hand over the seat to a colleague, who will then have to register for the course on our website prior to course start. If the registration is closed, please send us full name, email, phone and title of your colleague to bfl@atriumcph.com. Read our cancellation policy.

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This course is a part of this programme

Pharmacovigilance Diploma

An international training programme ... Read more

WANT TO KNOW MORE ABOUT THIS COURSE?

Contact Client Manager Ida Salicath at +45 39 15 09 46

Send an email

 

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