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Global Dossier for Clinical Development
Session Chair(s)
Mira Pavlovic, DrMed, MD, MS
HTA Expert /Director/HTA Professor
NDA Advisory Services, Medicines Development and Training (MDT) Services, France
Throughout the world differences in available treatment options, therapeutic and disease management guidelines, regulatory requirements, and criteria for pricing and reimbursement make common clinical development a major challenge. However, requirements to support product registration and access to market are more or less the same whatever the region: to provide evidence that a product is effective and safe when administered to patients with a given disease and when compared to placebo and/or a standard of care. We shall discuss requirements for a global product development and standardisation of outcomes for benefit-risk and relative effectiveness assessment in Europe and in the US.
Speaker(s)
Global Dossier – Acceptance of Foreign Data
Friedrich Asmus
Bayer, Germany
Global Clinical Leader Ophthalmology
Global Dossier – Regulatory View
Luca Pani, MD
University of Miami, United States
Former, AIFA; Professor, Department of Psychiatry and Behavioral Sciences
Sharon Evans Schuler
DIA, Switzerland
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