A Guide to Marketing Authorization Applications in Europe

A Guide to Marketing Authorization Applications in Europe

In this episode, host Harriet Edwards is joined by Dr Katherine Bowen to explore the regulatory fundamentals for obtaining marketing authorization in Europe, focusing on the centralised procedure. Together, they unpack the intricacies of this pathway, comparing it to the FDA application process and emphasising the critical role of thorough dossier preparation and clear communication with regulatory authorities. Key topics include the importance of early engagement with regulators, navigating the challenges of Module 1, developing risk management plans, and addressing current regulatory issues.

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Avsnitt(27)

EU Pharma Reform 2026: What Every Developer Needs to Know

EU Pharma Reform 2026: What Every Developer Needs to Know

In this episode, Katherine Bowen and Shalini Gupta discuss the EU pharmaceutical legislation reform — a comprehensive update to regulations and directives that will affect drug approval, orphan and pa...

7 Okt 37min

Live Biotherapeutics: Navigating the Next Frontier in Drug Development

Live Biotherapeutics: Navigating the Next Frontier in Drug Development

In this episode, Boyds' experts explore the emerging field of live biotherapeutic products (LBPs), explaining what they are, how they differ from everyday probiotics, and their roots in microbiome-bas...

22 Juni 32min

UK Clinical Trial Regulation: What Sponsors Need to Know About UK CTR 2025

UK Clinical Trial Regulation: What Sponsors Need to Know About UK CTR 2025

In this episode, experts at Boyds, Chris Moore and Shalini Gupta break down the UK Clinical Trial Regulation (UK CTR), exploring why the reform was introduced and highlighting the practical changes sp...

8 Apr 25min

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 Mars 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 Juli 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 Maj 202528min

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