Agenda
8:00 AM — 8:30 AM
8:30 AM — 8:45 AM
INTRODUCTION8:45 AM — 9:15 AM
KEYNOTE PRESENTATION9:15 AM — 10:30 AM
TOPIC 1: DEFINITIONS AND METHODS IN PHARMACOVIGILANCE10:30 AM — 11:00 AM
11:00 AM — 1:00 PM
Topic 1 Session 1 cont: Basic Definitions and Tools in Pharmacovigilance1:00 PM — 2:00 PM
2:00 PM — 3:30 PM
Topic 1 Session 2: Classical Methods in Pharmacovigilance3:30 PM — 3:45 PM
3:45 PM — 4:45 PM
Topic 1 Session 3: Introduction to Signal Detection6:15 PM — 7:15 PM
8:30 AM — 10:00 AM
TOPIC 2: REGULATORY ASPECTS IN PHARMACOVIGILANCE AND PRACTICAL EXAMPLES10:00 AM — 10:30 AM
10:30 AM — 12:00 PM
Topic 2 Session 1 cont: SUSAR Reporting in Clinical Trials and Case Studies12:00 PM — 1:00 PM
2:30 PM — 2:45 PM
2:45 PM — 3:30 PM
Topic 2 Session 4: Preparation of Periodic Safety Update Reports (PSURs)5:00 PM — 5:15 PM
10:15 AM — 10:30 AM
12:00 PM — 1:00 PM
1:00 PM — 1:45 PM
Topic 2 Session 7: Pharmacovigilance System Master File (PSMF)1:45 PM — 2:45 PM
Topic 2 Session 8: MedDRA and Standardised MedDRA Queries (SMQs)2:45 PM — 3:00 PM
4:00 PM — 4:15 PM
8:30 AM — 9:30 AM
TOPIC 3: DIAGNOSIS OF ADVERSE DRUG REACTIONS9:30 AM — 10:00 AM
TOPIC 4: SIGNAL DETECTION AND SIGNAL MANAGEMENT10:00 AM — 10:30 AM
10:30 AM — 12:00 PM
Topic 4 Session 2: Signal Management in the European Union: Industry Perspective12:00 PM — 1:30 PM
1:30 PM — 3:00 PM
Topic 4 Session 3: Signal Management – Workshop3:00 PM — 3:30 PM
3:30 PM — 5:00 PM
TOPIC 5: RISK MANAGEMENT8:30 AM — 10:30 AM
Topic 5 Session 2: Epidemiological Methods and Pharmacovigilance10:30 AM — 10:45 AM
10:45 AM — 11:45 AM
Topic 5 Session 3: Risk Management Plans: An Industry Perspective11:45 AM — 12:00 PM
12:00 PM — 12:30 PM
Topic 5 Session 4: Post-authorisation Development Plan (PASS/PAES)12:30 PM — 1:30 PM
Topic 5 Session 5: Effectiveness of Risk Minimisation MeasuresHave an account?