Dr Jean Temeck, Director of Pediatric International Program at the FDA Office of Pediatric Therapeutics has confirmed to speak at the 4th ECA Good Development Practice Conference on 18 - 20 May 2010 in Vienna about the implementation of the US Pediatric Legislation and ongoing international collaborations.
The EMA PDCO will be represented by Dr Ann Marie Kaukonen, Senior Researcher (Pharm. Assessor) at the National Agency for Medicines, Finland and PDCO member who will talk about quality expectations from the regulatory point of view.
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. Hear about best practices from early development up to process transfer and learn how Quality by Design and 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.
For further information please see the conference website.
On behalf of the European Compliance Academy (ECA)