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Complexity: Interplay and Interface of Different Legislations
Session Chair(s)
![Alberto Ganan Jimenez, PhD](/_Images/member/Generic_Image_Missing-Profile.jpg)
Alberto Ganan Jimenez, PhD
Head of Committees and Quality Assurance
European Medicines Agency, Netherlands
Tim Chesworth
Senior Director Regulatory Affairs
AstraZeneca, United Kingdom
The EU landscape of policies and regulations governing medicines research, development and manufacturing becomes increasingly complex. Products become more complex and more often than not consist of components regulated by different policies. But there are also unintended consequences where there is a pre-existing link between, for example, food and pharmaceutical rules, or where such link is created when new rules are set up. Developers of medicines must keep an eye not only on the legislation and guidance directly governing pharmaceutical products R&D and manufacturing but also on the interplay between other sectorial policies and legislations driven by considerations specific to food, device, diagnostics, chemicals, environment, data, etc. As a result, these other policies and regulations can either add to the evidence requirements increasing complexity and cost, or even contradict in some instances the principles on which medicines quality, safety and efficacy rely. The session will bring together medicine developers, policymakers, national and European regulators from different domains, patients and academics to shed light on examples of such complexities, their impact, pragmatic mitigation measures and general principles that should drive policy development to avoid that complexity turns into complications that prevent R&D or manufacturing in Europe.
Learning Objective : Discuss how to practically navigate the interplay between numerous EU legislations (food, chemicals, pharmaceuticals) their impact Europe’s competitiveness and attractiveness, and identify good practices in preventing, managing or mitigating negative impact.
Speaker(s)
Where Complexity turns into Complications
Magda Chlebus, MA
EFPIA - European Federation of Pharmaceutical Industries and Associations, Belgium
Executive Director, Science Policy & Regulatory Affairs
![Alberto Ganan Jimenez, PhD](/_Images/member/Generic_Image_Missing-Profile.jpg)
Where Complexity turns into Complications
Alberto Ganan Jimenez, PhD
European Medicines Agency, Netherlands
Head of Committees and Quality Assurance
Where Complexity Turns into Complications
Tim Chesworth
AstraZeneca, United Kingdom
Senior Director Regulatory Affairs
Panelist
Thomas Wejs Møller, MBA, MSc
Novo Nordisk, Denmark
Director Global Regulatory Affairs - Devices
![Laurence O'Dwyer, RPh](/_Images/member/Generic_Image_Missing-Profile.jpg)
Panelist
Laurence O'Dwyer, RPh
Health Products Regulatory Authority, Ireland
Scientific Affairs Manager
![Ferenc Marofka](/_Images/member/Generic_Image_Missing-Profile.jpg)
Panelist
Ferenc Marofka
European Commission, Belgium
Policy Officer Health Medecines
Panelist
Hubert Leufkens, PharmD, PhD
Utrecht University, Netherlands
Emeritus Professor of Pharmaceutical Policy and Regulatory Science
Take 5 & Closing
Marco Greco, PhD
European Patients' Forum, Belgium
President
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