Building a World-Class Regulatory Intelligence and Support System – Webinar Recording/Transcript
Want to improve compliance and avoid escalating penalties in an increasingly complex regulatory landscape?
You can, when you establish a regulatory intelligence management process.
With regulations growing in number and complexity, closer regulator scrutiny, unregulated countries becoming regulated and escalating consequences of noncompliance, a regulatory intelligence system is how you stay compliant.
In this environment, having one is crucial if you want to keep up with relevant changes. It will ensure you’re streamlining compliance with regulatory modifications throughout your organization, preparing for new and amended regulations impacting distribution and facilitating uninterrupted availability of your life-saving products to those who need them.
It can even help determine regulatory strategies for things like exploring new markets and product registration routes.
Two regulatory intelligence professionals from Edwards Lifesciences will explain how to institute such a system so you can secure the benefits.
Dennett Kouri, senior vice president, and Faviola Michelot, senior director, detail how to build a regulatory intelligence management system that will enable you to stay ahead of the changes and stay compliant.
- What regulatory intelligence is and how you can develop and implement it (e.g., roles, process workflow, stakeholder training)
- What resources are needed to support regulatory intelligence (e.g., subscription databases, using international support for global companies, establishing tools to track projects, action items)
- The new regulatory trends you must have on your radar (e.g., cybersecurity, unique device identifiers, standards, EU MDR regulations, newly regulated countries)
- How to pursue engaging opportunities with regulators (e.g., industry feedback per drafts)
- How to determine staff qualifications (e.g., regulatory affairs experience, proficiency in applicable tools, communication skills) for optimal efficiency
The penalties for noncompliance are soaring: greater fines, product disposal and extensive quarantined product holding periods, to name a few. You can stay compliant despite today’s complicated regulatory situation. All with your new regulatory intelligence system.
Meet Your Presenters
Dennett Kouri, senior vice president, has been with Edwards Lifesciences since 2006 in various senior leadership roles within its legal department as well as its corporate quality, regulatory and clinical departments. He has been at the forefront of driving strategic initiatives for Edwards in this space, including regulatory intelligence.
Faviola Michelot, senior director, has been with Edwards Lifesciences since 2014 and has been integral to developing, implementing and growing a best-in-class regulatory intelligence program within the company. She has a wealth of experience from past appointed positions within regulatory affairs at Integra Lifesciences and Medtronic.
Who Will Benefit
Regulatory professionals of all leadership levels involved in sustaining global supply chain operations, including those responsible for labeling, product registration, postmarket surveillance, marketing, etc.
Webinar Recording & Transcript Bundle
Add to Cart
Dec. 13, 2022