Programme topics

  • PKWP - BE/PK position on specific questions 
  • CMDh update - Practical regulatory experience in real life application of the newly issued guidelines
  • ICH M9 - Guideline in development on Biopharmaceutics Classification System (BCS)-based biowaivers
  • Biologics - Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials
  • Locally applied, locally acting products - Topicals
  • Multi-batch approach in BE testing - Multi-batch in clinical studies, which one to use in a final BE study
  • Ecotoxicology studies - Return of experience from Veterinary pharmacy and potential gain for Human medicine
  • Acceptance of old BE studies - Old clinical studies in approval of new application using MRP/DCP from a national application
  • Repositioning of existing APIs - new indications, dosing
  • Sponsor duties - Auditing CRO and monitoring of BE studies
  • Quality audits - Clinical batch manufacturing
  • Evaluation of dissolution similarity - Bootstrap, MSD