Developing a Regulatory Strategy

What is a regulatory strategy? And for that matter, what do people sometimes think is a regulatory strategy but isn’t? Those are the questions that today’s guest, Mike Drues, discusses as he begins his conversation with host John Speer, founder of Greenlight Guru. Mike is President of Vascular Sciences, an education, training, and consulting company that offers many services to medical device, pharmaceutical, and biotechnology companies. Listen to the episode to learn how Mike thinks about competitive regulatory strategy, delays in complying with regulation, and reimbursement and regulatory strategy.

QSR to QMSR: The Rewrite of 21 CFR Part 820 & Key Considerations for FDA Compliance
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QSR to QMSR: The Rewrite of 21 CFR Part 820 & Key Considerations for FDA Compliance

Implementing an eQMS: The Ultimate Move-In Guide for MedTech Leaders
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Implementing an eQMS: The Ultimate Move-In Guide for MedTech Leaders

Injecting Compliance into Code: Automating Compliance with AI in the MedTech SDLC
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Injecting Compliance into Code: Automating Compliance with AI in the MedTech SDLC

Forming Up A Regulatory Strategy: When And How To Start
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Forming Up A Regulatory Strategy: When And How To Start

Developing your regulatory strategies across pharma development and approval: UK, Euro and US models
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Developing your regulatory strategies across pharma development and approval: UK, Euro and US models

FDA aligns QMSR with ISO 13485?
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FDA aligns QMSR with ISO 13485?

The non-BS QMS for software enabled medical devices
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The non-BS QMS for software enabled medical devices

What do tech pioneers think about the AI revolution? - The Engineers, BBC World Service
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What do tech pioneers think about the AI revolution? - The Engineers, BBC World Service

Advancing Transparency and Regulatory Science Activities on Risk Evaluation and Mitigation Strategy
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Advancing Transparency and Regulatory Science Activities on Risk Evaluation and Mitigation Strategy

How to work with a medtech CRO and stay in control
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How to work with a medtech CRO and stay in control

GLP-1 Ripple Effect: Reshaping Injectable Drug Delivery
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GLP-1 Ripple Effect: Reshaping Injectable Drug Delivery

Move Fast and Stay Compliant: Rethinking Change Control for Software Medical Devices in Europe
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Move Fast and Stay Compliant: Rethinking Change Control for Software Medical Devices in Europe

Billionaire's WARNING: I'm SELLING. The Crash Is Already Here!
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Billionaire's WARNING: I'm SELLING. The Crash Is Already Here!

FDA Regulatory Education for Industry (REdI) Annual Conference 2023 – Devices Day 1
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FDA Regulatory Education for Industry (REdI) Annual Conference 2023 – Devices Day 1

Mass-Manufacturing a 5-in-1 Ventilator System for COVID-19 Relief
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Mass-Manufacturing a 5-in-1 Ventilator System for COVID-19 Relief

What does a strategy for regulatory compliance looks like?
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What does a strategy for regulatory compliance looks like?

Dave Ricks, CEO of Eli Lilly: How a 150 Year Old Company Keeps Winning
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Dave Ricks, CEO of Eli Lilly: How a 150 Year Old Company Keeps Winning

How to Focus to Change Your Brain | Huberman Lab Essentials
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How to Focus to Change Your Brain | Huberman Lab Essentials

What's The Function: Regulatory Strategy
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What's The Function: Regulatory Strategy

Why Manufacturing is Part of Product Development with Mike Dolphin
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Why Manufacturing is Part of Product Development with Mike Dolphin