Risk Management & Pharmacovigilance

Don't miss our DIA preconference tutorial on REMS Assessment Reports
- June 01, 2017
Creating a REMS assessment report requires a high-functioning, coordinated team effort, often involving numerous departments and external vendors. UBC’s REMS experts have designed, implemented, and/or evaluated more than 100 RiskMAPS...
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Our EU risk management experts provide insights on the new EMA guidance.
Janine Collins, MBBS, LLM, Sr. Director, European Risk Management, and Dafna Bonneh-Barkay, PhD, MSc, Sr. Project Manager - April 03, 2017
Introduction On Friday, 31 March 2017 the EMA released the revised Module V- Risk Management Systems (Rev 2) of Good Pharmacovigilance Practice (GVP) (EMA/838713/2011 Rev 2) accompanied by a revised Guidance on the format of the...
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An effective REMS program improves patient access to medication.
Annette Stemhagen, DrPH, FISPE, Senior Vice President, Safety, Epidemiology, Registries & Risk Management - February 14, 2017
The EXL Risk Evaluation & Mitigation Strategy Summit, held at the end of January, was an opportunity for colleagues across the industry to discuss many topics related to REMS, including benefit-risk counseling between patients and...
2017 pharmaceutical industry predictions
UBC - January 03, 2017
After weighing in on the biggest trends from the last year, we asked a few of our experts to predict the forces that would shape the industry in 2017. Optimizing the Value of Healthcare The focus of 2017 will be about realizing the...
2016 Trends in Pharma
UBC - December 13, 2016
If 2016 had an overriding theme it was one of instability. This sense of volatility manifested in a variety of ways from political clashes to Brexit, and the pharmaceutical industry was not immune. What remains constant is the...

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