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De Vere Canary Wharf

Oct 16, 2018 8:00 AM - Oct 17, 2018 5:15 PM

1 Westferry Circus, London, E14 4HD, United Kingdom

Regulatory Aspects in Pharmacovigilance and Practical Examples

This module will provide the safety reporting requirements with case studies, the roles and responsibilities of all stakeholders of clinical trials.

Agenda

Day 1 Oct 16, 2018

8:00 AM — 8:30 AM

REGISTRATION

8:30 AM — 10:00 AM

SUSAR Reporting in Clinical Trials and Case Studies

10:00 AM — 10:30 AM

COFFEE BREAK

10:30 AM — 12:00 PM

SUSAR Reporting in Clinical Trials and Case Studies continued

12:00 PM — 1:00 PM

LUNCH

1:00 PM — 1:45 PM

The Role of the Qualified Person Responsible for Pharmacovigilance

1:45 PM — 2:30 PM

Preparation of Development Safety Update Reports (DSURs)

2:30 PM — 2:45 PM

COFFEE BREAK

2:45 PM — 3:30 PM

Preparation of Periodic Safety Update Reports (PSURs)

3:30 PM — 5:00 PM

Expedited Reporting Requirements in the Post-authorisation Phase and Case Studies

5:00 PM — 5:15 PM

COFFEE BREAK

5:15 PM — 6:15 PM

Expedited Reporting Requirements in the Post-authorisation Phase and Case Studies continued

Day 2 Oct 17, 2018

8:30 AM — 10:15 AM

Expedited Reporting Requirements in the Post-authorisation Phase and Case Studies continued

10:15 AM — 10:30 AM

COFFEE BREAK

10:30 AM — 12:00 PM

Reporting Requirements in Special Situations in the Post-authorisation Phase and Case Studies

12:00 PM — 1:00 PM

LUNCH

1:00 PM — 1:45 PM

Pharmacovigilance System Master File (PSMF)

1:45 PM — 2:45 PM

MedDRA and Standardised MedDRA Queries (SMQs)

2:45 PM — 3:00 PM

COFFEE BREAK

3:00 PM — 4:00 PM

Audits and Inspections in Pharmacovigilance – Regulatory Perspective

4:00 PM — 4:15 PM

COFFEE BREAK

4:15 PM — 5:15 PM

Audits and Inspections in Pharmacovigilance – Industry Perspective

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Regulatory Aspects in Pharmacovigilance and Practical Examples

Agenda

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