EARLY DIALOGUE IN DRUG DEVELOPMENT

Track:
Effectiveness and Efficiency in the EU Regulatory system - Does new legislation work?

Day & Time:
March 5, 4:00PM - 5:30PM

Session Number:
1204

Room Number:
Auditorium GF

Level:
Intermediate

Type:
Session

Title:
EARLY DIALOGUE IN DRUG DEVELOPMENT

Chair(s):
Christine Mayer-Nicolai, PharmD
Head Europe, Global Regulatory & Scientific Policy
Merck KgaA, Germany

Description:
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(s):
Provide an overview on options for drug developers to intensify early dialogue with regulators and other stakeholders.

Presentation(s) & 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

Qualifications of Novel Methodologies for Drug Development: Experience to date and further options for use of the process
David Neil, MD,FFPM
Senior Medical Assessor
MHRA, United Kingdom

Industry Experience and Needs
Max Wegner
Head of GRA TA GM
Bayer Pharma AG, Germany