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Overview

DIA’s mission – to work across the healthcare continuum to ensure patients receive the therapies they need – is more essential than ever during times like these. DIA acknowledges the time and effort that has gone into planning and preparing for DIA’s Pharmacovigilance Strategies Workshop, and trusts that everyone will understand the need to respond to current, evolving health concerns in a responsible manner. These precautions are being taken to ensure the health and safety of our entire, global DIA family.

DIA is committed to exploring all possible avenues to provide a productive setting and a fulfilling meeting experience. We appreciate your patience as we work through any potential challenges.


Periodic safety surveillance and continuous improvement of quality and manufacturing controls of products are requiring marketing authorization holders to frequently engage with regulators and update their initial product licenses to the state of the art. However, coordinating regulatory activities with global manufacturing operations and supply of medicines have made appropriate change control a challenging task, specifically when differing requirements, processes and timelines are applied in different countries and regions. These divergent practices bear potentially unintended consequences and unnecessary supply disruption risks for products that are essential to patients.

Considering closer alignment with EU regulatory frameworks, this workshop will discuss the opportunities for convergence and streamlined regulatory management, assessment and approval of post-approval changes, which in turn will facilitate the efficient management of change control and better planning of global supply by manufacturers.  In addition, opportunities for more collaboration and reliance on regulatory marketing authorization assessments and renewals performed in national Health Authorities across countries and regions might have further positive impact on capacity and resources at regulator level and speed up the implementation of quality and safety changes for products on the market. This Workshop will also allow the participants to learn from best practice examples and share those learnings across boundaries.

Participants will get free access to the DIA eLearning course on variations to learn the basic principles and prepare for the conference discussions.

Featured topics

  • Regulatory Affairs
  • Regional Regulatory Development
  • Regulatory Compliance
  • Regulatory Submissions
  • ICH Guidelines implementation and development
  • CMC Lifecycle Management
  • CMC Project Management
  • Market Access
  • Patient Advocates
  • Policy
  • Supply chain

Learning objectives

• To get an update on the EU variation legislation and expected developments under ICH Q12
• Gain insights into managing variations in South East Europe and EU accession countries
• Involve in the discussion on how to optimize the post-approval framework for variations to facilitate uninterrupted product supply to patients
• Meet Health Authorities and Industry Leaders from EU countries and South Eastern Europe non-EU countries

 

Program Committee

  • Manuela  Stojanovic-Pejovski
    Manuela Stojanovic-Pejovski Executive Director
    Farmabrend Nova, North Macedonia
  • Ana  Petrovic
    Ana Petrovic Managing Director
    Association of Research-Based Medicine Producers in Bosnia & Herzegovina (UIPL), Bosnia and Herzegovina
  • Angelika  Joos, MPharm
    Angelika Joos, MPharm Executive Director, Global Regulatory Policy
    Merck Sharp & Dohme (Europe) Inc., Belgium
  • Ivana  Ferber, MPharm, MS
    Ivana Ferber, MPharm, MS Regulatory Affairs Lead Croatia/Bosnia and Herzegovina
    Merck Sharp & Dohme, Croatia (Hrvatska)
  • Maja  Lovrek, MPharm
    Maja Lovrek, MPharm Head of Medicines Authorisation Division
    Agency for Medicinal Products and Medical Devices, Croatia (Hrvatska)
  • Sara  Torgal, MPharm
    Sara Torgal, MPharm Scientific Programmes Manager
    DIA, Switzerland
  • Susanne  Ausborn, PhD
    Susanne Ausborn, PhD Global Head International Regulatory Policy
    F. Hoffmann-La Roche Ltd., Switzerland
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