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
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, parti...
7 Jan 202524min
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 Nov 202427min
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 Okt 202429min
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 Sep 202428min
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 Aug 202428min
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 Jul 202428min
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 Jul 202425min
