Overview

The interdependency between regulatory affairs and pharmacovigilance systems is translated in regulatory activities such as maintenance of the Summary of Product Characteristics, variations following referral procedures, preparation and maintenance of Risk Management Plans at the time of marketing authorisation application and submission of Aggregate Reports throughout the life-cycle of the product.

This webinar will explore the integrated environment between pharmacovigilance and regulatory affairs, focusing on the basics of signal management process and medical writing requirements.  

Learning objectives

• Have an overview of pharmacovigilance systems and processes
• Understand the general process of signal management
•  Understand how signal management is connected to regulatory activities
•  Learn about the specifics of Risk Management Plans and Aggregate Reports
•  Understand the regulatory requirements for submission of pharmacovigilance documents
  
   

Target Audience

• Regulatory Affairs professionals performing PV lifecycle management activities 
  
  

Speakers

Patricia Petric
Patricia Petric has been exposed to various areas of pharmacovigilance with major focus on signal detection and management, working as Pharmacovigilance Specialist in a global PV service provider and then transitioning to Roche as a Safety Scientist. Patricia has experience in continuous benefit-risk evaluation of medicinal products and preparation of specific reports used in signal management. 





Ioana Bajan
Ioana Bajan built her medical writer expertise on a strong pharmacovigilance background gathered in a global PV service provider, before transitioning to Roche as a Regulatory Documentation Specialist. Ioana has experience with risk management plans and aggregate reports prepared for various generic and innovative products in different lifecycle stages of development.

CPD

How do I register?

Prices

Discounted Places

A limited number of discounted places are available at the rates below for those:

• in low income countries as defined by the World Bank
• working for agencies, charities or NGOs. 

Please email meetings@topra.org for a discount code before making your booking.

* VAT, if applicable, is charged at a rate of 20%.

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