Dr Keith Webber, Deputy Director of the Office of Pharmaceutical Science, CDER, FDA has confirmed to speak at the 4th ECA Good Development Practice Conference on 18 - 20 May 2010 in Vienna about the FDA Point of View on Quality by Design.
The EMA PAT Team will be represented by Dr Riccardo Luigetti, Scientific Administrator at EMA's CHMP/CVMP Quality Working Party (QWP) and member of the EMA PAT Team who will talk about experiences and expectations of the EMA PAT Team.
More than 20 leading experts from authorities and industry have already accepted ECA's invitation to speak at this Conference.
The conference is set up in 2 parts, which can be booked separately:
Part 1: Quality by Design & Efficiency in Pharmaceutical Development on how Quality by Design and efficiency can be implemented in Pharmaceutical Development. Find out about best practices from early development up to process transfer and learn how Quality by Design can be realised.
Part 2: Formulation Development and Manufacturing of Paediatric Drugs on all relevant aspects of paediatric formulation development and manufacturing like for example suitable dosage forms, acceptable daily intake, taste masking, dosing accuracy, manufacturability and project management.
On behalf of the European Compliance Academy (ECA)