Agenda

Day 1 Oct 02, 2017

8:00 AM — 8:30 AM

REGISTRATION

8:30 AM — 8:45 AM

Introduction

8:45 AM — 9:15 AM

Keynote Presentation

9:15 AM — 10:30 AM

Basic Definitions and Tools in Pharmacovigilance

10:30 AM — 11:00 AM

COFFEE BREAK

11:00 AM — 1:00 PM

Basic Definitions and Tools in Pharmacovigilance continued

1:00 PM — 2:00 PM

LUNCH

2:00 PM — 3:30 PM

Classical Methods in Pharmacovigilance

3:30 PM — 4:00 PM

COFFEE BREAK

4:00 PM — 6:00 PM

Epidemiological Methods and Pharmacovigilance

6:00 PM — 7:00 PM

NETWORKING RECEPTION

Day 2 Oct 03, 2017

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 3 Oct 04, 2017

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

Day 4 Oct 05, 2017

8:30 AM — 9:30 AM

Medical Evaluation of Adverse Drug Reactions

9:30 AM — 10:30 AM

Introduction to Signal Detection

10:30 AM — 11:00 AM

Mobile Technologies and Social Media in Signal Management

11:00 AM — 11:30 AM

COFFEE BREAK

11:30 AM — 1:00 PM

Signal Management in the European Union: Industry Perspective

1:00 PM — 2:30 PM

LUNCH

2:30 PM — 4:00 PM

Signal Management – Workshop

Day 5 Oct 06, 2017

8:30 AM — 10:00 AM

Risk Communication in EU – Challenges and Possibilities

10:00 AM — 10:30 AM

COFFEE BREAK

10:30 AM — 12:00 PM

An Overview of the Risk Management Process & the PRAC. The main components of the RMP

12:00 PM — 1:00 PM

LUNCH

1:00 PM — 2:00 PM

Risk Management Plans: An Industry Perspective

2:00 PM — 2:30 PM

COFFEE BREAK

2:30 PM — 3:00 PM

Post-authorisation Development Plan (PASS/PAES)

3:00 PM — 4:00 PM

Effectiveness of Risk Minimisation Measures

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