Clinical Trial Application Success: CMC and Regulatory Insights from the US to Europe

The Investigational New Drug (IND) application in the US and Clinical Trial Application (CTA) in Europe are key milestones in advancing innovative therapies to clinical development. This webinar will discuss the technical and regulatory aspects of IND and CTA submissions in the US and Europe.

The speakers will explore CMC requirements, highlighting key technical challenges and practical solutions encountered during the early-phase development of both the drug substance and drug product. The speakers will also address the regulatory landscape, discussing EMA and FDA filing requirements, importation requirements for the EU and strategies for transitioning from US-based to EU-based trials.

Whether it’s a robust CMC strategy or a well-planned regulatory approach, both play a crucial role in enhancing the success rate and efficiency of IND submissions. Join this webinar to learn how expert perspectives from CMC and regulatory specialists can help minimize regulatory gaps, optimize timelines and streamline early-phase development.

Join the featured speakers to explore:

• Real-world insights on overcoming CMC hurdles during IND and CTA preparation
• Approaches to aligning technical documentation with evolving regulatory expectations
• Lessons learned from supporting global submissions across the US and EU

Register to gain practical insights on optimizing IND and CTA submissions through aligned CMC and regulatory strategies.

Speakers

William Lian, Director of Filing and Regulatory Affairs Office, BioDuro

With 14 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 eight years of experience in regulatory affairs, with a focus on China, the US, the EU, Taiwan, ASEAN, Korea and Japan.

William holds a BS in Chemistry from National Tsing Hua University (Taiwan) and is a PhD Candidate in Molecular Medicine at the same institution. After joining BioDuro-Sundia 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.

Read more...

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.

Read Less...

Message Presenter

Arna Hrund Arnardóttir, PhD, Senior Consultant, DADA

Arna is a pharmacist by training who in 2013 defended her thesis on benefit-risk assessment of pharmaceuticals, including post-marketing safety and different stakeholder views on the acceptance of new drugs to the market. Before she started her PhD, she had been working in the RA department of an Icelandic pharmaceutical company.

Read more...

Arna joined DADA in 2012 and, as a Senior Consultant, has been responsible for developing DADA’s Pharmaceutical Safety and Efficacy services. She has expertise in Good Clinical Practice and is qualified to perform GCP audits. Arna assists clients with clinical strategy, setting up sponsor QMS, preparing Scientific Advice applications and multiple other aspects of the Pharmaceutical Safety and Efficacy services relating to optimal clinical trial performance.

Read Less...

Message Presenter