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REGISTRATION
WELCOME AND INTRODUCTION OF FACULTY AND PARTICIPANTS
SESSION 1 • INTRODUCTION TO BENEFIT-RISK MANAGEMENT
Jan PETRACEK (Instructor)

• Key concepts and terminology
• Essential principles for benefit-risk management
• Foreseeable developments

  • Jan PETRACEK (Instructor)

    Jan PETRACEK (Instructor)

COFFEE BREAK
SESSION 2 • INTRODUCTION TO BENEFIT-RISK METHODOLOGIES
Michael FORSTNER (Instructor)

• The concept of risk
• Overview of qualitative and quantitative methods
• Use of the methodology by US and EU regulators

  • Michael FORSTNER (Instructor)

    Michael FORSTNER (Instructor)

SESSION 3 • EXAMPLES OF APPLICATION OF BENEFIT-RISK METHODOLOGIES
Michael FORSTNER (Instructor)

• ZHA, FMEA, FTA
• BR frameworks, Conjoint analysis, MCDA
• QALYs, NNTH/NNTB

  • Michael FORSTNER (Instructor)

    Michael FORSTNER (Instructor)

LUNCH
SESSION 4 • DESIGNING RISK MANAGEMENT SYSTEMS
Jan PETRACEK (Instructor)

DESIGNING RISK MANAGEMENT SYSTEMS

  • Jan PETRACEK (Instructor)

    Jan PETRACEK (Instructor)

SESSION 5 • DOS AND DON’TS IN SAFETY SPECIFICATION
Jan PETRACEK (Instructor)

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  • Jan PETRACEK (Instructor)

    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)

    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)

    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)

    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)

    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)

    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)

    Jan PETRACEK (Instructor)

SESSION 12 • USE OF BENEFIT-RISK MANAGEMENT PLANS IN REGULATORY
Jan PETRACEK (Instructor)

• Pre-authorisation – DSUR
• Post-authorisation – REMS, EU-RMP and PSUR
• EU-RMP

  • Jan PETRACEK (Instructor)

    Jan PETRACEK (Instructor)

COFFEE BREAK
SESSION 13 • A DECADE OF RISK MANAGEMENT FOR NSAID CLASS
F. Richard XIA, MD (Instructor)

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  • F. Richard XIA, MD (Instructor)

    F. Richard XIA, MD (Instructor)