Title: ATMP: Understanding the Regulatory Landscape for Tissue, Cell and Gene Therapy Development
Duration: 1 hour & 1 minute - Available On Demand
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 learning objectives:
- 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
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.