From 27/09/2022 To 27/09/2022

Starts at 09:00 until 17:00

Paul-Ehrlich-Institut Workshop: Scientific and Regulatory Aspects of Innovative Gene Therapy Medicinal Products

  • Address: Hybrid: City Hall Langen (Neue Stadthalle Langen), Germany and virtual
  • Organizer: Paul-Ehrlich-Institut
  • Language: English
  • Registration necessary: Yes

Introduction
Gene therapy medicinal products (GTMPs) are evolving rapidly as treatment options for patients with monogeneic disorders or malignant diseases such as lymphoma and leukemia. Innovative approaches including gene editing and RNA based gene therapies will pave the way for new clinical indications, but also pose new challenges for developers and regulators.
This workshop will provide an overview of development and regulatory aspects of novel gene therapies and presents a forum for an open exchange between all stakeholders.

Programme Committee

  • Dr Brigitte Anliker
  • Prof Dr Christian Buchholz
  • Dr Egbert Flory
  • Dr Matthias Renner
  • Dr Jürgen Scherer
  • Dr Martina Schüßler-Lenz

Objectives

  • Facilitate dialogue between developers and regulators
  • Discuss new developments such as gene editing, RNA-based therapies
  • Address new challenges regarding the Clinical Trials Regulation (EU) No 536/2014 and the GMO interface
  • Provide insights into quality, non-clinical and clinical requirements for gene therapy development

Target Audience

  • Developers including academia and industry (SME, biotech)
  • Health Care Professionals
  • Consortia
  • GMP authorities and Regulators
  • Health Technology Assessment and reimbursement bodies

Fees

  • Participation in the workshop is free of charge

Further Information
Details regarding the workshop programme and registration will follow soon. 

Workshop is organized by the Paul-Ehrlich-Institut and will be conducted as a hybrid meeting. For more information please visit our website.