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RISK PERCEPTION, RISK ACCEPTANCE AND KNOWN ACTIVE SUBSTANCES

Track:
New and Known Substances - how to fit the rules to needs

Day & Time:
March 27, 4:00PM - 5:30PM (Central European Standard Time)

Session Number:
1508

Room Number:
5AB

Type:
Session

Title:
RISK PERCEPTION, RISK ACCEPTANCE AND KNOWN ACTIVE SUBSTANCES

Chair(s):
Vesna Koblar, MD, PhD
Pharmaceutical Regulatory Affairs Consulting and E, Slovenia

Description:
Our decisions, although based on the same safety information on medicines, show diversity that implies. Our risk perception and risk acceptability differs across the EU depending on interested groups, cultural background and tradition. We will discuss the risk perception and risk acceptability from a National Competent Authority (NCA), a patient and industry point of view and try to find common points of understanding of risk acceptance and consequences in practice linked mostly to medicines with known active substances.

Presentation(s) & Speaker(s):
Risk Perception, Risk Acceptance and Known Active Substances – NCA point of view
Walter Schwerdtfeger, DrSc
President
BfArM, Germany

Patient Awareness of Off-Label Use of Know Active Substances and Risk Acceptability in Rare Paediatric Diseases
Tsveta Schyns
President
ENRAH, Belgium

Benefit-Risk Assessment of Established Substance
Hubertus Cranz, PharmD, MBA
Director-General
AESGP, Belgium