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Hilton London Canary Wharf

Apr 09, 2018 8:00 AM - Apr 11, 2018 4:30 PM

South Quay, Marsh Wall, London, E14 9SH, United Kingdom

Advanced Pharmacovigilance Auditing

You will learn how to prepare for the audit inspection in order to achieve best practices from the moment of facing the auditing visit notification to the moment of receiving the results and conclusions.

Agenda

8:00 AM8:30 AM

REGISTRATION AND WELCOME COFFEE

8:30 AM10:00 AM

GLOBAL PV PROCESSES (PART I)

10:00 AM10:30 AM

COFFEE BREAK

10:30 AM12:00 PM

GLOBAL PV PROCESSES (PART II)

12:00 PM1:00 PM

LUNCH

1:00 PM2:00 PM

SAFETY DATA EXCHANGE AGREEMENTS (SDEA) AND CONTRACTORS

2:00 PM2:30 PM

COFFEE BREAK

2:30 PM4:00 PM

CASE STUDIES

4:00 PM5:00 PM

NETWORKING RECEPTION

8:30 AM10:00 AM

AUDITS OF AFFILIATES AND THIRD PARTIES (PART I)

10:00 AM10:30 AM

COFFEE BREAK

10:30 AM12:00 PM

AUDITS OF AFFILIATES AND THIRD PARTIES (PART II)

12:00 PM1:00 PM

LUNCH

1:00 PM2:30 PM

RECONCILIATION PROCESS

2:30 PM3:00 PM

COFFEE BREAK

3:00 PM4:30 PM

COMPUTERISED SYSTEMS AUDITS

8:30 AM9:30 AM

AUDITS AS PREPARATION FOR A PV INSPECTION

9:30 AM10:00 AM

PRACTICAL EXERCISE (IN GROUPS)

10:00 AM10:30 AM

COFFEE BREAK

10:30 AM12:00 PM

EXPERIENCE DURING THE INSPECTION

12:00 PM1:00 PM

LUNCH

1:00 PM2:30 PM

POST-INSPECTION FOLLOW-UP

2:30 PM3:00 PM

COFFEE BREAK

3:00 PM4:30 PM

CASE STUDIES

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