$99 – $175

Workshop Pharmacovigilance - Ist Edition

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CRA School - International Clinical Research Academy

405 Avenue Ogilvy

Montréal, QC H3N 1M3

Canada

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Pharmacovigilance - an Essential Overview

This workshop is for anyone wishing to enter into or grow in the rewarding field of pharmacovigilance. Monitoring ongoing drug-related safety is a is a fundamental role of the pharmaceutical industry and a critical regulatory element of ensuring that patients are protected from harm. In addition, our Business Coach and Trainer will give a networking workshop on strategies to make connections and maximize relationships in growing your career.

The Workshop - A practical guide to understanding the role of pharmacovigilance


Key topics to be covered:

- Introduction to Pharmacovigilance

- Understand regulatory authorities' mandatory requirements (FDA, HC, EMA)

- Post-Marketing and Clinical trial Adverse Drug Reaction Reporting in Canada

- Key aspects of Individual Case Safety Reports (ICSR) processing and submission - Summary reports for post-Marketing Adverse Drug Reaction Reporting in Canada

- New mandatory pharmacovigilance regulations (Vanessa's law, Medical devices,....)

- Practical Cases in real operational Safety database


Why you should attend?

The Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) comes in force on December 16th, 2019 and hospitals do not have enough trained staff to implement it. These new regulations concerning pharma/hospital settings will increase the adverse event and medical device incident reporting requirements. Achieving compliance will be a significant challenge and this creates a unique opportunity to access new job openings in Pharmacovigilance.

The new pharmacovigilance legislation requires companies to train all staff, including those not working directly in pharmacovigilance. This workshop will meet that requirement.

Who should attend?

This workshop is of interest to those new to pharmacovigilance or working in support staff roles. It will also be relevant to anyone in regulatory affairs, clinical, sales & marketing, legal, commercial and quality, as well as professionals holding foreign degrees (MD, DDS, DVM, Pharm D, PhD, Nurses).

A certificate of attendance for professional development will be available to each participant who completes the course.


About the trainers:

Omar Aimer PhD is a pharmacist with over 10 years of experience focusing on Quality Assurance and Risk Management of Medical Devices in hospital environments. He pursued a Master of Pharmacovigilance and Drug Safety from Paris Descartes University. He has a strong knowledge of the European Medicine Agency's Pharmacovigilance Regulation and Good Pharmacovigilance Practices, and 5 years of experience in Pharmacovigilance in France. He now works in Canada as Pharmacovigilance Specialist at Brunel, on assignment with Sanofi Canada. Omar is an author and international speaker about the impact of Artificial Intelligence on Pharmacovigilance. He is also a mentor for students at McGill University for pharmacovigilance courses and is currently implementing eLearning pharmacovigilance training courses.

Yasmina Jimenez Graduate in Human Sciences from Concordia University, Yasmina is an International Business Coach, Corporate Trainer and CEO of MY WORKSHOP. She is a specialist in organizational development and leadership. After working for several years with NPOs servicing young people, women and newcomers in difficulty, Yasmina has been helping start-ups and SMEs in a variety of industries for over five years. This passionate entrepreneur is currently a mentor via Futurpreneur Canada, Yes Montreal, Concordia Alumni Connect and Réseau M. A fervent believer in diversity, equity and citizen participation, she also sits on several committees dedicated to these causes.


A certificate of attendance for professional development will be available to each participant who completes the course.

For more information contact us info@cra-school.com

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Date and Time

Location

CRA School - International Clinical Research Academy

405 Avenue Ogilvy

Montréal, QC H3N 1M3

Canada

View Map

Refund Policy

Refunds up to 1 day before event

Eventbrite's fee is nonrefundable.

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