Scientific and Regulatory Aspects of Innovative Gene Therapy Medicinal Products
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Location
City Hall Langen (Neue Stadthalle Langen)
Organiser
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