Sandeep Undavalli

Clinical Transparency Specialist at Novo Nordisk

Speaker

Sandeep has over 12 years of experience in clinical trials disclosure and transparency. He holds a Master of Pharmacy degree in Pharmaceutics from Jawaharlal Nehru Technological University. He has a deep understanding and proficiency in managing various aspects of clinical data disclosure. In his current role, he acts as a content responsible for the clinical transparency Standard Operating Procedures and plays an advocacy role to various regulatory authorities with respect to transparency/disclosure requirements, ensuring data disclosure practices are transparent, compliant, and of the highest quality. His expertise includes protocol registrations and results submissions on ClinicalTrials.gov, EudraCT and EU CTR; clinical document redaction/anonymization for public disclosure to support European Medicines Agency Policy 0070, Health Canada Public Release of Clinical Information, and other global disclosure regulations.