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 Maalis 30min
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 Loka 202526min
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 Heinä 202535min
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 Touko 202528min
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 Maalis 202532min
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 Helmi 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 Tammi 202524min
