Switzerland Chapter Virtual Event: Cell & Gene therapy

When:  Jun 18, 2025 from 11:00 to 15:15 (ET)

Cell and Gene Therapy (C&GT) represents one of the most innovative and transformative areas of modern medicine but with this promise comes unique regulatory and operational challenges. From ensuring patient safety and product consistency to navigating country-specific guidelines and reimbursement pathways, professionals must stay ahead of an ever-evolving global landscape.

This event brings together leading experts to share practical insights on international compliance frameworks, quality oversight, and decentralized manufacturing strategies for Cell & Gene Therapy products. Whether you're developing new therapies or managing regulatory submissions, this session will equip you with the knowledge to meet global expectations efficiently and effectively.

Registration Fees & Deadlines

Free

Who Should Attend?

This event is essential for regulatory affairs professionals, quality experts, and anyone involved in Cell & Gene Therapy development aiming to ensure global compliance and streamline product release.

Agenda

11:00–11:10

  • Introduction by Charlotte Serra

11:15–11:45

  • Bindhu Radhakrishnan — TGA regulatory expectations for Cell & Gene Therapy in Australia

11:45-12:15

  • Xiaoping Cao — Regulatory landscape for cell therapy in China

12:15-12:45

  • Jon Halling — MHRA regulatory requirements for Cell & Gene products in the UK

12:45-13:15

  • Stephane Gumy — The Cell & Gene Therapy landscape in Switzerland

13:15–13:30 Break

13:30–14:00

  • Charlotte Serra — Consistency by design & Central Quality Oversight for decentralized manufacturing platforms

14:00–14:30

  • Eileen Castro— PQRB, batch release, EU & US framework

14:30–15:00

  • Karin Hoogendoorn — Regulatory considerations for "Fresh" products: testing, quarantine shipment, release, and stability

15:00–15:30

  • Lindsay Davies   —   Moving towards rapid analytics for cell and gene therapies in Europe

Speakers

Bindhu Radhakrishnan
Director Of Quality at Cell Therapies, Cell Therapies

Xiaoping Cao
Consultant, Self employed

Jon Halling
Owner & Director, Alpha Biopharma Consulting Ltd

Stephane Gumy
General Manager, contracted Qualified Person & Senior Consultant, PMS Process Management System GmbH

Eileen Castro
Senior Director, Head of quality Operations US, Cell Therapy

Karin Hoogendoorn
CMC Project Leader, General Cell Therapy Technical Ops, Galapagos

Lindsay Davies
Co-founder, QVance

Charlotte Serra
VP, Global Head of Quality Operations, Cell therapy

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

Questions

Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email RAPS@raps.org