Prequalification: Training material

Training course

Training Workshop on Pharmaceutical Development with a Focus on Paediatric Formulations - Cape Town, South Africa, 
16 - 20 April 2007 

Background Information [pdf]
Programme [pdf]

Presentations:

16 April 2007

• Introduction to Workshop on Pharmaceutical Development with a Focus on Paediatric Formulations [ppt]

• Suitable dosage forms for paediatric medicine [ppt]

• Regulatory aspects of product development and the need for registration prior to marketing [ppt]
• Paediatric dosage forms - Case Study [ppt]

17 April 2007

• Physicochemical properties of APIs and their relevance to formulation [ppt]
• Excipients [ppt]
• PreFormulation Studies [ppt]
• Bioavailability and bioequivalence [ppt]
• From neonates to adolescents [ppt]
• Prescribing information and Patient information for paediatric medicines [ppt]

18 April 2007

• Developing a formulation and manufacturing procedure [ppt]
• Quality specifications and end-product testing [ppt]
• Stability testing of APIs and finished products [ppt]
• Analytical method development [ppt]
• Selection of packaging [ppt]

19 April 2007

• Regulatory requirements for the development of medicinal products for paediatric use [ppt]
• International Pharmaceutical Federation (FIP)  [ppt]

20 April 2007

• Introduction to WHO Prequalification Programme and Regulatory Aspects [ppt]
• Applications for prequalification: Dossier requirements [ppt]
• Post-registration variations  [ppt]
• Good Manufacturing Practices and Inspections [ppt]
• Approach to GMP in a Manufacturing Facility (Overview) [ppt]