Jörg Engelbergs, PhD

Scientific Regulatory Expert Biomedicines at Paul-Ehrlich-Institut (PEI), Federal Institute for Vaccines and Biomedicines


Title: Scientific-Regulatory Challenges for Co-Development of Drug and Companion Diagnostics in Europe

  • Overview of current CDx regulatory requirements in the EU
  • Challenges and requirements for analytical assay validation during clinical development
  • Considerations on complex (multimarker) assays
  • Ensuring diagnostic assay quality during clinical drug-Dx co-development and clinical routine