Paul-Ehrlich-Institut

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Scientific and Regulatory Aspects of Innovative Gene Therapy Medicinal Products

Begin

27.09.2022 09:00 AM

End

27.09.2022 05:00 PM

Location

City Hall Langen (Neue Stadthalle Langen)

Organiser

Paul-Ehrlich-Institut

Introduction

Gene therapy medicinal products (GTMPs) are evolving rapidly as treatment options for patients with monogenic 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

Registration

https://express.converia.de/frontend/index.php?page_id=25205&booking_registration_action=show&booking_registration_controller=offer

Registrations for personal participation can only be accepted until 15 September 2022.

On-site participation is only possible on request. Please contact regina.gutberlet@pei.de.

Further Information

Programme

Workshop is organized by the Paul-Ehrlich-Institut and will be conducted as a hybrid meeting.

Contact

Regina Gutberlet (Seminar Secretariat)
Phone: +49 6103 77 6001 oder +49 177 266 3925
Email: GMTP-Workshop@pei.de

Vera Mühl-Ulreich (Technical Support)
Email: v.muehl-ulreich@conventive.at