Agenda
8:00 AM — 8:30 AM
8:30 AM — 8:45 AM
INTRODUCTION8:45 AM — 9:15 AM
KEYNOTE PRESENTATION10:30 AM — 11:00 AM
1:00 PM — 2:00 PM
2:00 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
10:30 AM — 12:00 PM
TOPIC 2 SESSION 1 CONTINUED: SUSAR Reporting in Clinical Trials and Case Studies12:00 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
10:15 AM — 10:30 AM
12:00 PM — 1:00 PM
1:00 PM — 2:00 PM
TOPIC 2 SESSION 7: MedDRA and Standardised MedDRA Queries (SMQs)2:00 PM — 3:00 PM
TOPIC 2 SESSION 8: Pharmacovigilance System Master File (PSMF)3:00 PM — 3:15 PM
3:15 PM — 4:15 PM
TOPIC 2 SESSION 8 CONTINUED: Audits and Inspections in Pharmacovigilance4:15 PM — 4:30 PM
4:30 PM — 5:30 PM
TOPIC 2 SESSION 8 CONTINUED: Audits and Inspections in Pharmacovigilance9:30 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 Injury12:15 PM — 1:15 PM
2:15 PM — 3:15 PM
TOPIC 4 SESSION 4: Signal Management – Workshop3:15 PM — 3:30 PM
10:00 AM — 10:15 AM
10:15 AM — 11:15 AM
TOPIC 5 SESSION 3: Risk Management Plans: An Industry Perspective11:15 AM — 11:30 AM
11:30 AM — 12:00 PM
TOPIC 5 SESSION 4: Post-authorisation Development Plan (PASS/PAES)12:00 PM — 1:00 PM
TOPIC 5 SESSION 5: Effectiveness of Risk Minimisation Measures¿Tiene una cuenta?