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EARLY DIALOGUE IN DRUG DEVELOPMENT
Session Chair(s)
Christine Mayer-Nicolai, PharmD
Vice President, Regulatory and Scientific Policy
Merck Healtcare KGaA, Germany
The diversity of possibilities for interaction has increased over the last years. It is thus important to be aware of the different processes in order to define the best strategy to optimise drug development based on early dialouge.
Learning Objective : Provide an overview on options for drug developers to intensify early dialogue with regulators and other stakeholders.
Speaker(s)
Overview of Available Options for Early Dialogue and Which Procedure to Use for What Kind of Topic
Jan Mueller-Berghaus, MD
Paul-Ehrlich-Institut, Germany
Clinical Assessor
Qualifications of Novel Methodologies for Drug Development: Experience to date and further options for use of the process
David Neil, MD, FFPM
MHRA, United Kingdom
Senior Medical Assessor
Industry Experience and Needs
Max Wegner, PharmD, RPh
Bayer AG, Germany
Head Regulatory Affairs
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