Micro, small and medium-sized-enterprise (SME) workshop: Focus on chemistry, manufacturing and controls (CMC) regulatory compliance for biopharmaceuticals and advanced therapies

• Date:
  Thursday, 16 April 2015, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

This year's micro, small and medium-sized-enterprise (SME) workshop title 'Focus on chemistry, manufacturing and controls (CMC) regulatory compliance for biopharmaceuticals and advanced therapies' aims to provide training on topics such as building quality documentation early during development, manufacturing perspectives, veterinary products, CMC and investigational medicinal product dossiers (IMPDs), and analytical perspectives. Registration by invitation only. Registration open until 20/3/2015. Places limited.

Documents

Agenda - SME workshop: Focus on chemistry, manufacturing and controls (CMC) regulatory compliance for biopharmaceuticals and advanced therapies

Reference Number: EMA/49639/2015

Presentation - Recent experience in scientific advice and marketing authorisations (Brigitte Brake)

Presentation - Biological raw materials and viral/TSE safety (Johannes Bluemel)

Presentation - Potency and stability testing for ATMP (Marcel Hoefnagel, Charlotte De Wolf)

Presentation - SME workshop on CMC of biological medicinal products (Margarida Menezes Ferreira)

Presentation - CMC aspects of gene therapy medicinal products (Matthias Renner)

Presentation - GMP, quality by design and validation (Mats Welin)

Presentation - Manufacturing process changes, biologic product comparability and post approval changes (Nanna Aaby Kruse)

Presentation - CVMP ad hoc veterinary expert group on novel therapies ADVENT (Fia Westerholm)

Presentation - Preparing the CMC section of IMPD for biological/biotechnology derived substances (Una Moore)

Multimedia