ATMP: Understanding the Regulatory Landscape for Tissue, Cell and Gene Therapy Development

Duration: 1 hour & 1 minute

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Why watch

Summary

Innovative tissue, cell and gene therapies (also known as ATMP) play a considerable role in the evolution of new medicines. Yet, developers require clarity and advice in order to navigate the regulatory hurdles and achieve marketing authorization.

Key Learnings

Definition of Advanced Therapies in the EU and various examples
Overview on existing regulatory tools and how to use them to achieve marketing authorization
Regulatory highlights on Tissue, Cell and Gene therapies in EU and the US

speakers

A full day of inspirational speakers

Proud to bring inspirational speakers from across the globe.

Dr. Zaklina Buljovcic

Director, Principal Consultant Innovative Therapies, PharmaLex

Dr. Buljovcic is a Biologist and has 15 years of experience working in the Regulatory Affairs business, including 10 years specializing in Tissue, Cell and Gene therapies. She has successfully supported various companies and academia in their development up to marketing authorization. She also provides regular public seminars and in-house trainings.