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Hot Topics in Pharmacovigilance

Tutorial name:
Hot Topics in Pharmacovigilance

Day & Time:
April 16, 2:00PM - 5:30PM (Central Europe Standard Time)

Room Number:
Helvetia 4 (Swissotel)

Registration Fees
- Standard Rate€450.00


Instructor(s):
Sabine Brosch, PharmD, PhD, MPharm
Principal Scientific Administrator, Surveillance and Epidemiology
European Medicines Agency, European Union, United Kingdom

Anja Van Haren, DrSc, MSc
EudraVigilance Coordinator
Medicines Evaluation Board (MEB), Netherlands

Gunta Sveke,
Project Manager, Training Courses
DIA, Switzerland

Sabine Brosch, PharmD, PhD, MPharm
Principal Scientific Administrator, Surveillance and Epidemiology
European Medicines Agency, European Union, United Kingdom

Anja Van Haren, DrSc, MSc
EudraVigilance Coordinator
Medicines Evaluation Board (MEB), Netherlands

Gunta Sveke,
Project Manager, Training Courses
DIA, Switzerland

Description:

This short course will provide a forum to discuss the experience gained with the launch of the new EudraVigilance system, the simplified ADR reporting and access principles as well as the application of the provisions set out in Good Pharmacovigilance Practice Module VI, for which revision 2 was published in the 3rd quarter of 2017. The course will also address highlights of the signal management pilot, which was initiated in February 2018.

The course will provide an update on the initial implementation experience, discuss practical examples, address frequently asked questions and next steps.



Learning Objective(s):

At the conclusion of this short course, attendees will be able to:
• Discuss recent updates to GVP Module VI based on practical examples
• Describe the initial implementation experience with EudraVigilance
• Understand the impact of the simplified adverse reaction reporting and access to EudraVigilance
• Discuss highlights of the signal management



Target Audience:

This short course is designed for Qualified Persons Responsible for Pharmacovigilance (QPPVs) and pharmacovigilance experts including ICSR data entry and processing specialists.