Regulatory considerations of C&G therapies

In this SPARK Europe Webinar, Suzanne Einmahl (Ph.D. in Pharmaceutical Sciences) will explore the latest regulatory guidelines, challenges, and best practices in the development and approval of cell and gene therapies.

 

Zoom

Join us for an insightful webinar on Regulatory Frameworks for Cell and Gene Therapy!
Whether you're a researcher, clinician, or industry professional, this webinar will provide essential knowledge to navigate the complex regulatory landscape and accelerate the path to market. Suzanne will share some practical aspects to have in mind when transitioning from fundamental to translational research. She will also provide concrete examples why implementing a regulatory strategy early on helps optimizing drug development.

Suzanne Einmahl (Ph.D. in Pharmaceutical Sciences), shares her insights in regulatory affairs in Cell and Gene Therapies. Suzanne is an independent consultant in regulatory affairs and a medical writer at Albedo Consulting Sàrl, that she founded in 2021. Previously, Suzanne spent over 17 years as a Senior Scientific Consultant at Triskel Integrated Services SA. She also served as the Director of Regulatory Affairs at SFL Regulatory Affairs & Scientific Communication GmbH. Over her 23 years of experience, she contributed to the development of more than 60 medicinal products, including cell and gene therapies. Her expertise includes regulatory strategy, interactions with regulatory agencies, preparation and submission of marketing applications in the EU and US, and clinical development strategy.

Online via Zoom | Please register HERE!

Registration to the webinar is required in advance. Please register no later than 1st April 2025. Please note that you will receive the Zoom link and access code the evening before the lecture and that access to last minute registrations, cannot be guaranteed.

SPARK Europe is the joint network of SPARK sites all over Europe including Israel: SPARK-BIH, SPARK Finland, SPARK FLI, SPARK Norway, SPARK Poland, SPARK Tel Aviv, SPARK Denmark, SPARK Zürich and SPARK at the Faculty of Medicine, Masaryk University. European SPARK programs are members of SPARK Global network. The purpose of SPARK programs is to provide the education and mentorship necessary to advance research discoveries from the bench to the bedside, hence to increase the maturity of academic and clinical discoveries towards practical solutions that address unmet needs in the life science and health tech space. The program follows the same principles that have been the cornerstones of SPARK at Stanford since it was established by Professor Daria Mochly-Rosen and Kevin Grimes in 2006 for advancing new biomedical research discoveries into promising new treatments for patients.

 

SPARK-BIH is a member of the SPARK Global network