Technical and legal requirements for ATMP development

Description:

Join this expert session offering an overview of Creatio’s capabilities and its role in supporting the development of advanced therapies and medicinal products. The session will provide practical insight into the regulatory framework associated with ATMP’s development, covering key stages from preclinical development to clinical translation, GLP/GMP readiness, and manufacturing.

Agenda

9.30-9.35 Welcome Maria Terrades, CEO Parc Científic de Barcelona

9:35-10:45 Technical and legal requirements for ATMP development, from preclinical to clinical manufacturing, Josep M. Canals, Prof., Creatio, Unai Perpiñà, PhD, Creatio, Andrea Comella Bolla, PhD, MBA

A clear understanding of technical and regulatory requirements is essential to building an efficient, robust, and well-aligned R+D pathway. Addressing the early considerations can help anticipate challenges, avoid future setbacks, reduce translational risk, and better plan the time and cost associated with development. Most importantly, it supports the successful advancement of safe, effective, and high-quality medicines to patients and the clinic in a timely and cost-effective manner.

This 1-hour session is intended for researchers, spin-offs/companies, and innovation-driven projects seeking to strengthen their understanding of the regulatory and operational factors that shape successful ATMP development. The session will feature three expert presentations, followed by coffee networking and the opportunity to book 20-minute 1:1 meetings with experts. For 1:1 meeting contact [email protected]

10:45-11:00 Questions & Answers

11:00 Coffee

Bio speakers

Josep M. Canals, Prof.

Director of Creatio and Professor at the University of Barcelona, with extensive expertise in advanced therapies, translational research, and innovation transfer. He serves on national and international expert committees in the fields of ATMPs, regulation, stem cells, and neurodegenerative disorders.

Unai Perpiñà, PhD

Qualified Person and Technical Manager of the Clinical Production Area at Creatio, specialized in ATMP quality, validation, regulatory requirements, and clinical-grade manufacturing.

Andrea Comella Bolla, PhD, MBA

Director of Strategy and Management at Creatio, with a background in translational research, advanced therapies, and strategic management in biotech/biomed sector.

Please note: Photos may be taken durins this event and used for marketing future events. If you do not wish to apper in photos, it is your responsability to inform the photographer

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Host or Publisher Creatio (UB) i Parc Científic de Barcelona