First EMEA Workshop on Advanced Therapy Medicinal Products (ATMPs)

EventAdvanced therapies

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Date: Fredag, 3 april 2009, Hele dagen
Placering: European Medicines Agency, Amsterdam, the Netherlands

Documents

Agenda - First Workshop on Advanced Therapy Medicinal Products (ATMPs)

Reference Number: EMEA/119832/2009

English (EN) (32 KB - PDF)

Først publiceret: 09/03/2009 Senest opdateret: 09/03/2009

Regulation and Introduction - Patrick Celis

English (EN) (250.7 KB - PDF)

Først publiceret: 03/04/2009 Senest opdateret: 03/04/2009

The Committee for Advanced Therapies (CAT) - Lucia D'Apote

English (EN) (821.76 KB - PDF)

Først publiceret: 03/04/2009 Senest opdateret: 03/04/2009

Challenges with Advanced Therapy Medicinal Products - Christian K Schneider

English (EN) (1.55 MB - PDF)

Først publiceret: 03/04/2009 Senest opdateret: 03/04/2009

EMEA Innovation Task Force Experience - Marisa Papaluca

English (EN) (410.19 KB - PDF)

Først publiceret: 03/04/2009 Senest opdateret: 03/04/2009

Business Pipeline Activity - Enrico Tognana

English (EN) (113.68 KB - PDF)

Først publiceret: 03/04/2009 Senest opdateret: 03/04/2009

Overview of the Procedure and interactions between CAT and CHMP - Marie-Helene Pinheiro

English (EN) (1.82 MB - PDF)

Først publiceret: 03/04/2009 Senest opdateret: 03/04/2009

Certification Procedure - Elisa Pedone

English (EN) (104.4 KB - PDF)

Først publiceret: 03/04/2009 Senest opdateret: 03/04/2009

Scientific Recommendation on the Classification of ATMPs - Marie-Helene Pinheiro

English (EN) (1.51 MB - PDF)

Først publiceret: 03/04/2009 Senest opdateret: 03/04/2009

Technical requirements for Annex I - Patrick Celis

English (EN) (298.81 KB - PDF)

Først publiceret: 03/04/2009 Senest opdateret: 03/04/2009

Quality requirements for cell-based medicinal products - Paula Salmikangas

English (EN) (603.15 KB - PDF)

Først publiceret: 03/04/2009 Senest opdateret: 03/04/2009

Scientific requirements for cell therapy and tissue engineered products: Non-clinical and clinical aspects - Giovanni Migliaccio

English (EN) (236.77 KB - PDF)

Først publiceret: 03/04/2009 Senest opdateret: 03/04/2009

Quality and manufacturing aspects of GTMPs - Sol Ruiz

English (EN) (1.35 MB - PDF)

Først publiceret: 03/04/2009 Senest opdateret: 03/04/2009

Requirements for gene therapy products: Non-clinical and clinical aspects - Gopalan Narayanan

English (EN) (80.28 KB - PDF)

Først publiceret: 03/04/2009 Senest opdateret: 03/04/2009

Risk Management of Advanced Therapies, Dossier Requirements - Jan Petracek

English (EN) (340.66 KB - PDF)

Først publiceret: 03/04/2009 Senest opdateret: 03/04/2009

First EMEA Workshop on Advanced Therapy Medicinal Products (ATMPs) - List of participants

English (EN) (55.53 KB - PDF)

Først publiceret: 03/04/2009 Senest opdateret: 03/04/2009