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.

Jaksot(24)

The Use of ATMPs in Oncology Clinical Trials

The Use of ATMPs in Oncology Clinical Trials

How can phase I studies with ATMPs address unmet needs in oncology and what are the challenges? In this episode of Conversations in Drug Development, Dr Katherine Bowen is joined by Pharmaceutical Phy...

21 Touko 202419min

How are GMO Regulations Impacting Clinical Development in Europe?

How are GMO Regulations Impacting Clinical Development in Europe?

In this episode of Conversations in Drug Development, our host Harriet Edwards, is joined by Director of Regulatory Affairs, Dr Sabine Ruehle, to discuss the challenges of navigating genetically modif...

25 Huhti 202424min

US Drug Development: The Latest Regulatory Trends and Initiatives

US Drug Development: The Latest Regulatory Trends and Initiatives

In this episode of Conversations in Drug Development, host Dr Harriet Edwards is joined by Katy Rudnick and Dr Julie Warner from Boyds to discuss US regulatory trends and initiatives at the FDA. This ...

19 Maalis 202422min

The Regulatory Challenges of Rare Disease Drug Development

The Regulatory Challenges of Rare Disease Drug Development

To celebrate Rare Disease Day, we are back with another Conversation in Drug Development, this time discussing the unique challenges of rare disease drug development. Dr Eric Hardter, Associate Direct...

28 Helmi 202429min

The Drug Development Landscape: Trends and Predictions for 2024

The Drug Development Landscape: Trends and Predictions for 2024

We are kickstarting 2024 with a Conversation in Drug Development with CEO and Founder of Boyds, Professor Alan Boyd. In this podcast episode, our host Harriet Edwards, and Professor Alan Boyd discuss ...

22 Tammi 202425min

Off-the-Shelf Cell Therapies: Breaking Barriers and Revolutionizing Patient Care

Off-the-Shelf Cell Therapies: Breaking Barriers and Revolutionizing Patient Care

In this episode of "Conversations in Drug Development", Harriet Edwards and Dr. Patrick Ginty discuss off-the-shelf cell therapies, explaining how these therapies are manufactured and their ability to...

4 Joulu 202320min

The Future of Drug Development: AI’s Role in Revolutionizing the Industry

The Future of Drug Development: AI’s Role in Revolutionizing the Industry

In this episode of Conversations in Drug Development, Dr. Julie Warner and Harriet Edwards discuss the revolutionizing role of artificial intelligence (AI) in drug development, exploring its applicati...

8 Marras 202322min

Recent Trends in Oncology Drug Development

Recent Trends in Oncology Drug Development

In this episode, Dr Katherine Bowen and Dr Julie Warner delve deep into the ever-evolving world of oncology drug development and the regulatory landscape in the US and EU. Join us in this conversation...

4 Loka 202325min

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