Prequalification: Training Workshop

Training Workshop on Pharmaceutical Development with a Focus on Paediatric Formulations

       Beijing, P. R. China  21 - 24 June 2010

Background Information  [pdf]

Programme  [pdf] 

Workshop Report  [pdf]

Monday, 21 June

• The need for paediatric medicines: a WHO perspective (English version & Chinese version)  [pdf]

• From neonates to adolescents (English version & Chinese version)  [pdf]

• Biopharmaceutical Classification System (BCS)  (English version & Chinese version)  [pdf]

• Ethical considerations in clinical trials (English version & Chinese version)  [pdf]

• Bioavailability and bioequivalence studies in paediatrics (English version & Chinese version)  [pdf]

• Pharmacovigilance and safety of medicines in children  (English version & Chinese version)  [pdf]

Tuesday, 22 June

• Dosage form design and manufacture (English version & Chinese version)  [pdf]

• Scientific principles: Excipients, colorants, flavours and API properties (English version & Chinese version)  [pdf]

• Selection of packaging materials (English version & Chinese version)  [pdf]

• Practical problems in developing Fixed Dose Combinations and bilayer tablets - Industry representative
  (English version & Chinese version)  [pdf]

• Practical problems in developing Fixed Dose Combinations and bilayer tablets - Industry representative
  (English version & Chinese version)  [pdf]

• Suitable dosage forms for paediatrics (English version & Chinese version)  [pdf]

Wednesday, 23 June

• Introduction to development pharmaceutics (English version & Chinese version)  [pdf]

• Industry perspective on practical approaches and experiences in development pharmaceutics (English version & Chinese version)  [pdf]

• Selecting and developing an appropriate paediatric dosage form using a Quality by Design approach (English version & Chinese version)  [pdf]

• Stability testing of APIs and finished products (English version & Chinese version)  [pdf]

• Analytical Method Development (English version & Chinese version)  [pdf]

Thursday, 24 June

• Introduction to the Prequalification of Medicines Programme (English version & Chinese version)  [pdf]

• Application for Prequalification: Dossier requirements (English version & Chinese version)  [pdf]

• Inspections in Prequalification (English version & Chinese version)  [pdf]

• Dossier maintenance - including variations (English version & Chinese version)  [pdf]