Understanding EU Medical Device Regulations: Key Insights for Developers and Innovators

Understanding EU Medical Device Regulations: Key Insights for Developers and Innovators

In this episode, host Harriet Edwards is joined by Eamonn McGowran, an expert in medical device regulations, to explore the complex and rapidly evolving regulatory landscape for medical devices, particularly within the EU.

Eamonn highlights the challenges of developing combination products that integrate devices and pharmaceuticals, the roles of notified bodies and competent authorities, and the importance of early stakeholder engagement. The episode also covers the integration of artificial intelligence in medical devices and the evolving UK regulatory framework post-Brexit.

Episoder(24)

How Will the EU Biotech Act Transform Biotechnology Regulation in Europe?

How Will the EU Biotech Act Transform Biotechnology Regulation in Europe?

In this episode of Conversations in Drug Development, host Harriet Edwards is joined by Kelsey Lennoch and Eamon McGowran to discuss the EU Biotech Act, a major regulatory proposal aimed at revitalizi...

10 Mar 30min

Navigating the FDA Landscape: More Changes, and What's Next?

Navigating the FDA Landscape: More Changes, and What's Next?

In this episode, Eric Hardter and guest Kelsey Lenoch discuss recent US FDA developments, including leadership changes at CBER and CDER, staffing impacts on orphan product reviews, and the new Rare Di...

23 Okt 202526min

At the forefront of innovation: Prof Alan Boyd reflects on the last 20 years in drug development

At the forefront of innovation: Prof Alan Boyd reflects on the last 20 years in drug development

In this special episode of Conversations in Drug Development, host Harriet Edwards sits down with Professor Alan Boyd, founder and CEO of Boyds, to reflect on the company’s remarkable 20-year journey ...

26 Aug 202539min

Navigating the New FDA Landscape: Opportunities and Challenges Ahead

Navigating the New FDA Landscape: Opportunities and Challenges Ahead

In the latest episode of Conversations in Drug Development, Dr Katherine Bowen and Dr Eric Hardter discuss the ever-changing US regulatory landscape under the new administration, including new leaders...

15 Jul 202535min

From Lab to Launch – Avoiding the Pitfalls of Drug Development

From Lab to Launch – Avoiding the Pitfalls of Drug Development

In this episode, Dr Neil Fish and Dr Ami Patel dive into the real-world challenges of drug development - from early-stage planning to regulatory hurdles and everything in between. Drawing on decades o...

29 Mai 202528min

Crystal Ball Gazing: What Does the Future Hold for Regulatory Affairs in Drug Development for 2025

Crystal Ball Gazing: What Does the Future Hold for Regulatory Affairs in Drug Development for 2025

In this episode, Harriet Edwards from Boyds hosts a discussion on 2025 predictions in drug development and regulatory affairs. Joined by regulatory experts Dr. Katherine Bowen and Dr. Eric Hartder, th...

17 Mar 202532min

How to Effectively De-Risk your IND Process

How to Effectively De-Risk your IND Process

In this episode, Dr. Nick Meyers and Dr. Eric Hardter, discuss effective strategies for de-risking Investigational New Drug (IND) applications. Discover key insights on how to navigate the complexitie...

11 Feb 202552min

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