Pharma

Strategize your Risk Management Plan in 2 steps

by Fleming. Team

Read below the interview with Judy to reveal the latest trends in risk management and find out what are the most important steps towards strategizing your risk management plan.

Judy Hsiung Senior Medical Director, Head of Safety Sciences Halozyme

Judy will discuss the topic of Strategizing Risk Management Plans – New Rules and Priorities in a focused discussion at the upcoming 4th Annual Pharmacovigilance & RMS Forum (September 27 – 28, 2017, Key Bridge Marriott, Washington D.C.).


North America Pharma

Pharmacovigilance and Risk Management Strategies

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1. What are the latest trends in risk management?

The latest trends are to be proactive, bring epidemiology in at an earlier stage, to plan for global PV infrastructure earlier as there is an increased trend towards inspection readiness across all systems of risk management, including the clinical database and how all of the systems of the company speak to each other.

2. What is your number 1 priority in your risk management plans?

Our number 1 priority is to ensure that baseline epidemiology and prevalence of important identified risks is delineated from the beginning in order to properly differentiate the true signals and risks.

3. What are the main steps towards strategic risk management?

Cross-functional participation and “cross-pollination” are key as the importance of having strategic risk management is critical and cannot be done in a silo. There are widespread implications across an entire organization when RM is not performed properly.

4. What are your expectations for risk management in 2017-2018?

My expectations are that it will continue to evolve and become more proactive, particularly in smaller, biotech companies, and that risk management considerations will be brought into play earlier in the lifecycle of key development compounds.

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