Prequalification: Training Material

Training Workshop on Pharmaceutical Development with a Focus on Paediatric Formulations

       Tallinn, Estonia,  15 - 19 October 2007 

       Background information [pdf]
      

      Programme (English)  [pdf]
      Programme (Russian) [pdf]

Presentations (English & Russian Versions Below):

Monday, 15 October 2007

• The need for paediatric medicines: a WHO perspective & Russian Version [ppt]

• Introduction to the WHO Prequalification Programme and Regulatory Aspects & Russian Version  [ppt]

• Good Manufacturing Practices and Inspections & Russian Version [ppt]

• Application for Prequalification and maintenance of prequalification: Dossier requirements & Russian Version [ppt]

• Capacity building components of the Prequalification Programme  [ppt]

Tuesday, 16 October 2007

• From Neonates to adolescents  & Russian Version  [ppt]

• Suitable dosage forms for paediatric medicines & Russian Version  [ppt]

• Bioavailability and bioequivalence in paediatrics & Russian Version  [ppt]

• Prescribing information and Patient information for paediatric medicines & Russian Version  [ppt]

Wednesday, 17 October 2007

• Physicochemical properties of APIs and their relevance to formulation [ppt]

• Excipients & Russian Version [ppt]

• Pre-formulation studies & Russian Version [ppt]

• Selection of packaging & Russian Version [ppt]

Thursday, 18 October 2007

• Developing a formulation and manufacturing procedure & Russian Version [ppt]

• Quality specifications and end-product testing & Russian Version [ppt]

• Analytical Method Development & Russian Version [ppt]

• Stability Testing & Russian Version [ppt]

Friday, 19 October 2007

• Regulatory aspects of product development & Russian Version [ppt]

• Regulatory requirements applied on the medicinal products for paediatric use [ppt]

• Regulatory requirements on dossier of medicinal product & Russian Version [ppt]