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Poster Session 1 – Regulatory and Health Policy
Session Chair(s)
Sara Torgal, MPharm
Senior Manager, Scientific Programs
DIA, Switzerland
Poster authors will present their poster in a short pitch format, followed by a moderated Q&A.
Learning Objective : Highlight benefits and challenges of establishing the regulatory intelligence function within a matrix organisation.
Speaker(s)
Synergies between Regulatory Intelligence and Other Functions within Pharmaceutical Industry
Budhesh Dhamija, MPharm
ITM Oncologics GmbH, Germany
Senior Director, Head of Clinical Regulatory Affairs
Nanomedicines – Ensuring Patient Safety Through Regulatory Clarity
Michael Paul Isles
European Alliance for Access to Safe Medicines - EAASM, United Kingdom
Executive Director
Synthetic Follow-ons to Biologic Medicines – Are They Similar or Same?
Henrik K. Nielsen, PhD, MBA, MSc
Novo Nordisk A/S, Denmark
Vice President
A Comparative Analysis of FDA and EMA Approvals for PD-1/PD-L1 Inhibitors Linked to Specific PD-L1 Thresholds
Rebecca Shin, PharmD
Bristol-Myers Squibb, United States
Post-Doctoral Fellow
Adopting Artificial Intelligence (AI) for Document Submissions: putting theory into practice
Tina Barton, BSN, MD, PMP
Emerging Markets Quality Trials (EMQT) , United Kingdom
Chief Operating Officer
How to obtain High-Quality Real-World Data and Evidence for Regulatory Submissions
Sam Ringle, PhD
CSL Behring Innovation Gmbh, Germany
EU Regulatory Affairs Manager
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