Pharmacovigilance Data in Application and Registration

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

  • TBD

2 days course

English

11.200,- DKK ex VAT
(app. 1.506,- EUR ex VAT)

At the moment there is no available dates for this course.

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
Post Authorization Safety Studies (PASS)
Summary of Product Characteristics (SPCs)
Applications for New Medicinal Products
Risk Management Plan
Risk Minimization

What you will learn

 

  1. The relationship between pharmacovigilance and the processes of application and registration
  2. How to analyze the different pre-application tasks related to pharmacovigilance
  3. How to use what you have learned to deliver higher quality input to the application process
  4. How you can help improve cooperation between the clinical development, registration and pharmacovigilance units

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

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 on the day of the course, you can hand over your seat to a colleague. To hand over your seat, please contact us at +45 39 27 60 60. Read our cancellation policy.

WANT TO KNOW MORE ABOUT THIS COURSE?

Contact Programme Director Gitte Hornemann Møller at +45 39 15 09 20

Send an email

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