Selected topics:

• Biowaivers of all types
• ICH M15: PBPK, IVIVC, pop PK
• CRO practical experience: inflation of guidelines vs EMA guideline and PSBGs – practical experience, unresolved issues, frequent mistakes/misunderstandings
• Frauds in datasets
• ICH M13A reflections and practical use
• ICH M13B
• OIP/nasal: dissolution, MDRS
• Antiacid/drug-drug interactions
• Synthetic peptides
• Complex generics