Please register for this webinar here.
Join Sharon, Associate Director and Senior Regulatory Consultant for DLRC (a group of award-winning, regulatory affairs consultants strategically located across two continents), for this SPARK Studio session.
Sharon joined DLRC in January 2022, bringing over 20 years of experience in nonclinical development and an additional 6 years in regulatory affairs. With a strong focus on nonclinical regulatory strategy, she supports clients across all stages of the product life cycle—from early-phase development, Scientific Advice, and PIPs, to INDs, MAA/NDA/BLA submissions, and post-approval procedures. Her work spans various research and therapeutic areas and includes both small molecules and biologics.
Sharon has extensive experience in developing and implementing nonclinical regulatory strategies tailored to product-specific and regional requirements, ensuring alignment with both EU and US regulatory expectations. She has held positions in contract research organizations, large pharmaceutical companies, and small biotech firms, and has successfully led nonclinical regulatory activities for multiple small molecule and biologics filings in both the EU and US.
Common Non-Clinical Deficiencies & Issues in Regulatory Submissions
Non-clinical studies form the backbone of early drug development, providing critical safety and pharmacological data that support the initiation and continuation of clinical trials. Despite their importance, regulatory submissions such as INDs, CTAs, MAAs, and NDAs frequently encounter delays or setbacks due to avoidable non-clinical deficiencies. These issues often stem from gaps in study design, documentation, regulatory misalignment, or failure to meet region-specific expectations. This presentation aims to highlight the most common non-clinical pitfalls observed by regulatory agencies and offer practical strategies to enhance submission quality, minimise regulatory risk, and ensure a smoother path to clinical development and marketing approval.
This webinar is sponsored through Aston University’s active involvement with the West Midlands Health Tech Innovation Accelerator (WMTHIA). The WMHTIA is funded by the Department for Science, Innovation and Technology, in partnership with the West Midlands Combined Authority and Innovate UK.