アジェンダ
8:30 AM — 9:00 AM
9:00 AM — 10:30 AM
SESSION 1: QUALITY SYSTEM IN PHARMACOVIGILANCE10:30 AM — 11:00 AM
11:00 AM — 12:30 PM
SESSION 2: AUDITS IN PHARMACOVIGILANCE12:30 PM — 1:30 PM
1:30 PM — 3:00 PM
SESSION 3: EUROPEAN AND FDA INSPECTIONS3:00 PM — 3:30 PM
3:30 PM — 5:00 PM
SESSION 3 CONTINUED: EUROPEAN AND FDA INSPECTIONS5:00 PM — 6:00 PM
8:30 AM — 10:00 AM
SESSION 4: PHARMACOVIGILANCE REQUIREMENTS AND FINDINGS10:00 AM — 10:30 AM
10:30 AM — 12:00 PM
SESSION 5: RESPONDING TO THE FINDINGS AND PREPARING THE CAPA12:00 PM — 1:00 PM
1:00 PM — 2:30 PM
SESSION 6: ONSITE AUDIT/INSPECTION2:30 PM — 3:00 PM
3:00 PM — 4:30 PM
SESSION 6 CONTINUED: ONSITE AUDIT/INSPECTION