With the EU’s pharmaceutical legislation reform soon to come into force, regulatory experts outline what is changing across both US and European frameworks and how sponsors can position pipelines ahead of implementation.
Regulatory change is underway on two fronts. FDA review practice has evolved meaningfully over recent review cycles, and the EU has finalised a sweeping reform of its pharmaceutical legislation that has not yet entered into force. For sponsors filing an IND with the FDA, preparing an EMA submission, or planning a Phase II expansion into the EU, this session offers an early look at what’s changing and how to get ahead of it.
In this session, William Lian (BioDuro) covers the current FDA IND landscape: where IND submission changes, how Clinical Holds get resolved, and why getting CMC right early is the key to avoiding them. William will also introduce FDA’s evolving expectations for nonclinical development, including initiatives such as the increased use of new approach methodologies (NAMs).
Miranda van Bodegom (DADA Consultancy) turns to the EU, where the change is legal, not procedural. She unpacks several developments under what EMA itself has called “the most significant overhaul of the regulatory framework in over two decades”. Miranda will introduce upcoming changes covering development and registration phases, pharmacovigilance and regulatory aspects, the new approach to environmental risk, and the expanded the use of Master Files.
Join BioDuro and DADA Consultancy to find out what’s changing and what sponsors should be preparing for.
What you will learn:
- Why FDA Clinical Holds happen and how CMC readiness prevents them
- Whether FDA’s NAMs shift changes your preclinical testing plan
- Whether you qualify for a Master File under the EU’s pharmaceutical legislation reform
- How to navigate the European ‘green legislation’
- How to position your pipeline now, ahead of these changes taking full effect.
Regulatory expectations are changing before the legislation takes effect. Reserve your place to learn what sponsors should be doing now to avoid delays and stay ahead of new FDA and EU requirements.
Miranda van Bodegom is Senior Consultant Regulatory Affairs, DADA Consultancy.
In early 2018, she joined the Regulatory Affairs department at DADA, where she works as a Senior Consultant Regulatory Affairs. She coordinates marketing authorisation processes (DCP, MRP and national applications) in Europe, starting at the marketing authorisation application (MAA), and providing procedural support during eCTD lifecycle management. She furthermore specialises in writing product information texts and she supports DADA’s Pharmaceutical Safety and Efficacy team in preparing the clinical and non-clinical overviews of the pharmaceutical dossier. Besides this, Miranda acts as a client manager for various clients, providing support for diverse projects. Miranda finished her master’s degree in Medical Biology in 2017 at the Radboud University in Nijmegen.
William Lian is Director of Filing and Regulatory Affairs Office, BioDuro.
With 15 years of experience in drug discovery and development, William Lian has specialized expertise in Computer-Aided Drug Design (CADD), generic drug development, and investigational new drugs (IND). William has managed 60+ projects for over 40 clients, advancing innovation in pharmaceutical development. He has over 10 years of regulatory affairs experience, with a focus on China, the US, the EU, Taiwan, ASEAN, Korea, and Japan.
As a certified Project Management Professional (PMP®) and Certified Quality Technician (CQT), William has demonstrated strong leadership, communication, and project management skills. His experience includes managing GMP processes, responding to audits, and focusing on regulatory compliance and quality assurance.
After joining BioDuro in 2018, he oversees regulatory compliance and project management. His previous experience includes leading the Quality Assurance Department at Tai-Yu Chemical and Pharmaceutical Co. Ltd., where he was the primary responder for PIC/S GMP, GDP, and medical device audits. William holds a BS in Chemistry from National Tsing Hua University (Taiwan) and is a PhD Candidate in Molecular Medicine at the same institution.
Is the panel discussion free?
Yes – there is no charge to watch the panel discussion, either live or on-demand.
When will the panel discussion take place?
The webinar will be taking place on 16 September 2026 at 4 PM BST | 11 AM EDT | 8 AM PDT
Can I watch it later?
The panel discussion will become available to watch on-demand shortly after the live webinar takes place.
What are the benefits of attending live?
You’ll be able to ask the speakers your questions, which will be answered live in the Q&A towards the end of the session.
How long will the panel discussion be?
This panel discussion will last up to an hour.
What do I need to watch this panel discussion?
All you need is a computer with an internet connection. We recommend using headphones if possible if you’re in an office environment.
