Understanding PhV Today - A Training Course on the Principles and Practice of Global PhV for Those Working in Drug Safety (London, United Kingdom - December 4-5-6, 2017) - Research and Markets

DUBLIN--()--Research and Markets has announced the addition of the "Pharmacovigilance" conference to their offering.

This course aims to provide basic training for those concerned with pharmacovigilance. New entrants as well as experienced operators in drug safety monitoring will benefit from the mixture of scientific knowledge and practical guidance. In addition, detailed information will be provided on regulatory developments in pharmacovigilance in Europe, the USA, and Japan.

This three-day introductory course is aimed at personnel in research and development departments, adverse reaction monitoring units, regulatory affairs and registration departments; pharmaceutical physicians and drug safety officers. It will also be of direct benefit to all those who are involved and interested in the daily practice of pharmacovigilance.

Key Topics to Be Addressed at the Pharmacovigilance Conference:

- Principles of Pharmacovigilance and Data Resources

- Risk Management and Risk Minimisation

- Causality Assessment: Clinical Diagnosis of Adverse Events

- PASS and PAES Studies

- Regulatory Framework

- European Post-Marketing Pharmacovigilance Regulations

- Pharmacoepidemiological Studies

- Evolution of PSURs, PBRERs and DSURs - Pro-active Pharmacovigilance Pre- and Post Marketing

- Clinical Trial ADR reporting requirements

- Risk/Benefit Assessment

- Drug Surveillance in countries outside Europe

- Examples of pharmacoepidemiological studies used in risk management

- Introduction to Signal detection

- Introduction to Risk Management plans

- Practical Pharmacovigilance Workshop

Agenda:

Day 1 Schedule

Registration and coffee

Principles of Pharmacovigilance and Data Resources

Risk Management and Risk Minimisation: Basic Principles

Causality Assessment: Clinical Diagnosis of Adverse Events

The Current Regulatory Framework and its Global Impact

European Post-Marketing Pharmacovigilance Regulations

End of Day One and Drinks Reception

Day 2 Schedule

Pro-Active Pharmacovigilance Pre-and Post Marketing

Risk/Benefit Assessment

Clinical: Trial ADR Reporting Requirements

Pharmacoepidemiology Studies - Basic Designs, Strengths, Weaknesses and Examples

Where are We Now with PSURs (or PBRERs)

What do we submit now and when is it required?

Close of day two

Day 3 Schedule

Drug Surveillance in Countries Outside Europe

Practicalities of Signal Detection

Examples of Pharmacoepidemiological Studies Used in Risk Management

Practicalities of Risk Management

Practical Pharmacovigilance Workshop

Close of day three

For more information about this conference visit http://www.researchandmarkets.com/research/s8f6d9/pharmacovigilance

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Drug Discovery

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Drug Discovery