WEBINAR

November 19, 2024 11:00am ET/8:00am PT/05:00pm CET


In the fast-paced world of pharmaceutical development, balancing the complexities of early-stage research, regulatory requirements, and compliance is critical for achieving successful Investigational New Drug (IND) submissions. Early-stage 'fit-for-purpose' development focuses on producing batches for GLP toxicology studies, ensuring initial GMP production, and addressing regulatory challenges, while supporting the pharmacology and pharmacokinetics of drug candidates.

This webinar offers expert insights into managing IND filings efficiently with real-world case studies. The presentation will touch on key aspects of early-stage development, such as generating the necessary pharmacological and toxicological data, while maintaining an emphasis on optimizing API and formulation R&D and production, impurity controls, and the overall regulatory submission process.

Join us as we explore practical steps to harmonize compliance, timelines, and costs, ensuring a smooth transition from preclinical development to successful IND filings and clinical trials.

Register now


Learn about our speaker
William LIAN
Director of Filing and Regulatory Affairs Office, BioDuro-Sundia
With 13 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 8 years of regulatory affairs experience, with a focus on China, the US, the EU, Taiwan, ASEAN, Korea, and Japan.
William holds a B.S. 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.
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 focus on regulatory compliance and quality assurance.
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