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 modified organism (GMO) regulations in clinical trials within Europe. This discussion helps decipher the nuanced environment of GMOs and their associated risks unique within the European framework. Join us as we explore the outdated definition of GMOs, the complexities of their classification, and the impact of genome editing technologies.

Jaksot(24)

Patients as Partners: Advocacy's Role in Shaping Drug Development

Patients as Partners: Advocacy's Role in Shaping Drug Development

In this episode, host Harriet Edwards and Senior Clinical Project Manager, Chris Moore, discuss the vital role of patient and public involvement in drug development, particularly within clinical trial...

8 Marras 202427min

Navigating the Future of EU Health Technology Assessments

Navigating the Future of EU Health Technology Assessments

In this episode, host Dr Julie Warner is joined by experts from Decisive Consulting, Esther Nzenza, and Kevin Asher to discuss the upcoming joint clinical assessment (JCA) process set to begin in Janu...

16 Loka 202429min

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. Tog...

24 Syys 202428min

Navigating the new EU Clinical Trials Regulation

Navigating the new EU Clinical Trials Regulation

In this episode, host Harriet Edwards is joined by Dr Katherine Bowen and Shalini Gupta to explore the transformative changes in the European Union's clinical trial landscape. The focus is on the tran...

13 Elo 202428min

Advances in Cell-Based Immunotherapies: CAR-T Cell Therapy vs TCR Therapy

Advances in Cell-Based Immunotherapies: CAR-T Cell Therapy vs TCR Therapy

In this episode, host Harriet Edwards is joined by two regulatory experts from Boyds, Dr Patrick Ginty and Monica Pianella, to discuss cell-based immunotherapies, focusing on CAR-T cells and TCR-T cel...

25 Heinä 202428min

Demystifying Regulatory Designations in Drug Development

Demystifying Regulatory Designations in Drug Development

In this episode, Dr Katherine Bowen and Dr Julie Warner delve into the world of regulatory designations, providing clarity on what these designations offer, the products that qualify, and the pros and...

10 Heinä 202425min

Exploring Genome Editing Technologies in Drug Development

Exploring Genome Editing Technologies in Drug Development

In this episode, host Dr. Katherine Bowen, is joined by Harriet Edwards, Associate Director in Regulatory Affairs, to explore the fascinating world of genome editing technologies. Together, they delve...

19 Kesä 202423min

The Most Essential Tips for Biotechs Seeking Investment

The Most Essential Tips for Biotechs Seeking Investment

Welcome to a special edition of Conversations in Drug Development, brought to you by the team at Boyds.  In this episode, our host Harriet Edwards hands over the mic to two of her colleagues to discus...

3 Kesä 202423min

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