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Session 5: Advanced Therapies and Gene Editing
Session Chair(s)
Livia Lopes
LatAm Regulatory Affairs Policy Manager
Novartis, United States
In this session we will discuss advanced therapies and gene editing topics including advances made, requirements, challenges, and perspectives for the future. The idea is to have the contextualization from both regulators and industries on this multidisciplinary theme.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Identify the current regulatory context of advanced therapies/gene editing
- Know the difficulties in the regulatory field of advanced therapies/gene editing
- Understand the next steps planned for the regulation of advanced therapies/gene editing
Speaker(s)
Regulatory updates, perspectives and challenges on Advanced Therapies and Gene Editing
Judith A Arcidiacono, MS
FDA, United States
International Regulatory Expert, Office of Tissues and Advanced Therapies, CBER
Regulatory updates, perspectives and challenges on Advanced Therapies and Gene Editing
Patricia Aprea, MD
ANMAT, Argentina
Director, Evaluation and Control of Biológicals/Research
PANDRH’s Concept Note and Recommendations on Regulation of Advanced Therapy Medicinal Products
Fernanda Lessa, MBA, MPH
Consultant, Switzerland
Health Regulatory Systems
Regulatory Experience/Process in International Markets
Carl P Denny, MS, MSc
Avexis, Inc., United States
Sr. Director - Regulatory Affairs
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