Date
- Friday, 3 April 2009, All day
Location
- European Medicines Agency, Amsterdam, the Netherlands
Documents
Agenda - First Workshop on Advanced Therapy Medicinal Products (ATMPs)
English (EN) (32 KB - PDF)
Regulation and Introduction - Patrick Celis
English (EN) (250.7 KB - PDF)
The Committee for Advanced Therapies (CAT) - Lucia D'Apote
English (EN) (821.76 KB - PDF)
Challenges with Advanced Therapy Medicinal Products - Christian K Schneider
English (EN) (1.55 MB - PDF)
EMEA Innovation Task Force Experience - Marisa Papaluca
English (EN) (410.19 KB - PDF)
Business Pipeline Activity - Enrico Tognana
English (EN) (113.68 KB - PDF)
Overview of the Procedure and interactions between CAT and CHMP - Marie-Helene Pinheiro
English (EN) (1.82 MB - PDF)
Certification Procedure - Elisa Pedone
English (EN) (104.4 KB - PDF)
Scientific Recommendation on the Classification of ATMPs - Marie-Helene Pinheiro
English (EN) (1.51 MB - PDF)
Technical requirements for Annex I - Patrick Celis
English (EN) (298.81 KB - PDF)
Quality requirements for cell-based medicinal products - Paula Salmikangas
English (EN) (603.15 KB - PDF)
Scientific requirements for cell therapy and tissue engineered products: Non-clinical and clinical aspects - Giovanni Migliaccio
English (EN) (236.77 KB - PDF)
Quality and manufacturing aspects of GTMPs - Sol Ruiz
English (EN) (1.35 MB - PDF)
Requirements for gene therapy products: Non-clinical and clinical aspects - Gopalan Narayanan
English (EN) (80.28 KB - PDF)
Risk Management of Advanced Therapies, Dossier Requirements - Jan Petracek
English (EN) (340.66 KB - PDF)
First EMEA Workshop on Advanced Therapy Medicinal Products (ATMPs) - List of participants
English (EN) (55.53 KB - PDF)