アジェンダ
8:00 AM — 8:30 AM
8:30 AM — 9:15 AM
9:15 AM — 10:30 AM
Topic 1 Session 1: BASIC DEFINITIONS AND TOOLS IN PHARMACOVIGILANCE10:30 AM — 11:00 AM
11:00 AM — 12:45 PM
Topic 1 Session 1 continued: BASIC DEFINITIONS AND TOOLS IN PHARMACOVIGILANCE12:45 PM — 1:45 PM
1:45 PM — 3:30 PM
Topic 1 Session 2: CLASSICAL METHODS IN PHARMACOVIGILANCE3:30 PM — 4:00 PM
4:00 PM — 6:00 PM
Topic 1 Session 3: EPIDEMIOLOGICAL METHODS AND PHARMACOVIGILANCE6:00 PM — 7:00 PM
10:00 AM — 10:30 AM
12:00 PM — 1:00 PM
1:45 PM — 2:30 PM
Topic 2 Session 3: PREPARATION OF PERIODIC SAFETY UPDATE REPORTS (PSURs)3:15 PM — 3:30 PM
5:00 PM — 5:15 PM
10:30 AM — 11:00 AM
12:30 PM — 1:30 PM
1:30 PM — 2:30 PM
Topic 2 Session 7: PHARMACOVIGILANCE SYSTEM MASTER FILE (PSMF)2:30 PM — 2:45 PM
2:45 PM — 3:45 PM
Topic 2 Session 7 continued: PHARMACOVIGILANCE SYSTEM MASTER FILE (PSMF)3:45 PM — 4:00 PM
4:00 PM — 6:00 PM
Topic 2 Session 7 continued: AUDITS AND INSPECTIONS IN PHARMACOVIGILANCE8:30 AM — 9:30 AM
Topic 3 Session 1: MEDICAL EVALUATION OF ADVERSE DRUG REACTIONS9:30 AM — 10:30 AM
Topic 3 Session 2: DRUG-INDUCED LIVER INJURY10:30 AM — 11:00 AM
11:00 AM — 11:30 AM
Topic 3 Session 2 continued: DRUG-INDUCED LIVER INJURY11:30 AM — 12:30 PM
Topic 3 Session 3: QT/QTc PROLONGATION AND THE RISK OF TORSADE DE POINTES12:30 PM — 1:30 PM
1:30 PM — 2:15 PM
Topic 4 Session 1: MedDRA AND STANDARDISED MedDRA QUERIES (SMQs)2:15 PM — 3:00 PM
Topic 4 Session 2: INTRODUCTION TO SIGNAL DETECTION3:00 PM — 3:30 PM
3:30 PM — 4:30 PM
Topic 4 Session 3: SIGNAL MANAGEMENT IN THE EUROPEAN UNION8:30 AM — 9:45 AM
Topic 5 Session 2: RISK MANAGEMENT COMPONENTS: GENERAL PRINCIPLES9:45 AM — 10:45 AM
Topic 5 Session 3: RISK MANAGEMENT PLANS: AN INDUSTRY PERSPECTIVE10:45 AM — 11:15 AM
11:15 AM — 11:45 AM
Topic 5 Session 4: POST-AUTHORISATION DEVELOPMENT PLAN (PASS/PAES)11:45 AM — 12:45 PM
Topic 5 Session 5: EFFECTIVENESS OF RISK MINIMISATION MEASURES