Chemistry of Active Substances Guideline: EMA Request Feedback
Published Jan 20, 2025
Published 01st August 2024
Rare cancers in oncology are an area of significant unmet need but are challenging to address due to their infrequent occurrence and unique characteristics. Addressing these challenges requires a multifaceted and collaborative approach. Development of targeted therapies, efficient clinical trial design, access to medicines and optimised regulatory processes are essential for advancing treatment options for rare cancers and improving patient care. This whitepaper provides a comprehensive overview of considerations for industry stakeholders, including the opportunities and support available for small and medium-sized enterprises (SMEs).
Urvi is a Regulatory Consultant at DLRC with over 15 years of experience in Regulatory Affairs. Her career includes roles at AstraZeneca and several Generic pharmaceutical companies. Urvi has successfully led numerous regulatory submissions including new Marketing Authorisation Applications (MAAs) and license maintenance activities. She also has experience in clinical trials, scientific advice, health authority interactions as well as Oncology and Cardiovascular therapeutic areas.
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