SESSION 4 • DESIGNING RISK MANAGEMENT SYSTEMS Jan PETRACEK (Instructor)
DESIGNING RISK MANAGEMENT SYSTEMS
Jan PETRACEK (Instructor)
SESSION 5 • DOS AND DON’TS IN SAFETY SPECIFICATION Jan PETRACEK (Instructor)
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Jan PETRACEK (Instructor)
SESSION 6 • TOOLBOX FOR PHARMACOVIGILANCE PLANNING Michael FORSTNER (Instructor)
• Pharmacovigilance toolbox • Design of studies and registries used in pharmacovigilance planning • Matching safety concerns with appropriate pharmacovigilance tools
Michael FORSTNER (Instructor)
COFFEE BREAK
SESSION 7 • EFFICACY SPECIFICATION AND FOLLOW-UP PLAN Jan PETRACEK (Instructor)
• Creation of efficacy specification and relevant regulatory discussions in EU-RMPs and PSURs(PADERs) • Design of studies and registries used in the efficacy follow-up planning • Matching efficacy concerns with the efficacy follow-up planning
Jan PETRACEK (Instructor)
SESSION 8 • OPTIONS FOR RISK MINIMISATION Michael FORSTNER (Instructor)
• Risk minimisation toolbox • Matching safety concerns with the risk minimisation tools • Safety communication
Michael FORSTNER (Instructor)
NETWORKING RECEPTION
SESSION 9 • EVALUATION OF RISK MINIMISATION EFFECTIVENESS Michael FORSTNER (Instructor)
• Tools and methodologies available • Levels of metrics • Required evaluation levels and examples of satisfactory results
Michael FORSTNER (Instructor)
COFFEE BREAK
SESSION 10 • BENEFIT-RISK MANAGEMENT PLAN – CASE STUDIES Jan PETRACEK (Instructor)
• Small molecules and generics • Biologics and biosimilars • Advanced therapies • Combination therapies
Jan PETRACEK (Instructor)
LUNCH
SESSION 11 • BENEFIT OPTIMISATION Jan PETRACEK (Instructor)
• Benefit management toolbox • Matching efficacy/effectiveness concerns with the benefit management tools • Measuring success of benefit optimisation
Jan PETRACEK (Instructor)
SESSION 12 • USE OF BENEFIT-RISK MANAGEMENT PLANS IN REGULATORY Jan PETRACEK (Instructor)