Preconference Workshop

Applied

Drug Development in EU: Regulatory Standards, Support and New Approaches

Workshop Leader(s)

• 

  Andrea Laslop, MD

  Head of Scientific Office, Austrian Medicines and Medical Devices Agency

Speaker(s)

• MD

  Matthias Dormeyer, Dr

  Managing Director
• 

  Sabine Haubenreisser, MSc, PhD

  Principal Scientific Administrator
  European Medicines Agency
• 

  Karl-Heinz Huemer, MD, PhD

  Medical Assessor
  AGES (Austrian Agency for Health & Food Safety)
• 

  Jan Mueller-Berghaus (virtual presenter), MD
• 

  Bjorn Oddvar Strom, MPharm, PdD

  Senior Scientific Advisor
  Norwegian Medicines Agency
• 

  Maria Concepcion Yerro, MD, PhD

  Spanish Agency for Medicines and Medical Devices

Pharmaceutical companies intending to develop and register drugs for the European market need to be aware that the regulatory network in the EU has its own requirements and characteristics which differ in a number of aspects from FDA. Knowledge of the general and distinctive features of the centralized regulatory system in the EU, as coordinated by EMA, with special focus also given on novel regulatory approaches, will benefit successful development and approval of drugs in Europe. Drug development is a multi-step approach that involves a number of opportunities and requirements for interaction with regulatory authorities, spanning from the design and approval of clinical trials, use of scientific advice and other support programs during development, definition of potential orphan status, and pediatric development to specific aspects of advanced therapy products and ways of approval and post-marketing activities/commitments. This workshop will address the various regulatory steps and explain the role of the European regulator not only as being a gate-keeper but also an enabler supporting successful development. Established and new approaches, as provided by the European regulatory network, will be presented and discussed on the basis of anonymized examples and on discussion of practical cases/questions contributed by workshop attendees.

Agenda

Learning Objectives:

• Choose a tailored way of interacting with EU regulators in order to receive support in drug development.
• Define strategic goals for successful submission of a marketing authorization application of a drug intended for the European market.
• Describe the role of European National Competent Authorities and Committees at the EMA, including their impact on various stakeholders in healthcare.