Post-Marketing Surveillance

Do you understand the complexity of Post-Marketing Surveillance?

  • 2. May 2018

3 days course

English

17.350,- DKK ex VAT
(app. 2.333,- EUR ex VAT)

Module 4

Summary

This course will help you understand the different aspects of post-marketing surveillance, risk management planning, post-authorization safety studies, and signal management process tools for signal detection, interpretation and handling of findings.

After the course, you will be able to analyze and interpret signals and findings. You will also know how to use and prepare risk management plans, update Summary of Product Characteristics (SPCs), execute recalls, and manage a product life cycle.

The course is offered every 1 1/2 years.

Keywords

Pharmacovigilance Legislation and Guidance Documents
Signal Management
Periodic Safety Update Report (PSUR) and Risk Management Systems
Signal Detection
Crisis Management
Risk Communication
Product Life Cycle Management
New Transparency Tools

What you will learn

 

  1. The different aspects of post-marketing surveillance
  2. How to analyze and interpret signals and findings
  3. How to use and prepare risk management plans, update SPCs, execute recalls and manage a product life cycle
  4. How to share knowledge in relation to post-marketing surveillance
  5. How to operate in a dynamic and changing environment

What your company will get

 

  1. A safety and pharmacovigilance professional who understands the different aspects of post-marketing surveillance
  2. A safety and pharmacovigilance professional who can independently analyze and interpret signals and findings
  3. A safety and pharmacovigilance professional who can provide valuable input to all other team members working with post-marketing surveillance
Available start dates

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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