Scientific advice by the Paul-Ehrlich-Institut and the Committee for Medicinal Products for Human Use

Open to all EKFZ-associated members

Speakers

Dr. Jens Reinhardt (Paul-Ehrlich-Institut)

Description

• How can a promising new research result be translated from the bench to bedside?
  What are the regulatory challenges and how can they be maneuvered?
  How are regulatory authorities supporting this process?

  Dr. Jens Reinhardt, a regulatory scientist at Paul-Ehrlich-Institut and a member of the Scientific Advice Working Party of the European Medicines Agency (EMA), is presenting the advice possibilities given by the upper regulatory agencies in Germany and the Scientific Advice at EMA.
  He will explain the remits and the procedures of the agencies and give examples on dos and don’ts of advices. The presentation is intended for researchers looking to translate their research into clinical application and everybody interested in regulation of medicinal products. After the talk, workshop participants will have the opportunity to network and exchange ideas with Dr. Reinhardt while enjoying drinks and finger food.