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Clinical Data Disclosure Europe
7-8 November, 2024
Amsterdam Marriott HotelAmsterdam, The Netherlands

Maria-Giovanna Gualazzi
Clinical Transparency & Regulatory Disclosure/EU CTR Implementation Lead at Ipsen


Maria-Giovanna is leading the Data Transparency team within the Global Regulatory Affairs at Ipsen, being responsible of the development of the company's clinical transparency strategy. She is also directing the implementation of the EU CTR at corporate level, a role that required her to identify business needs to ensure operational readiness. This has involved supporting the update and operationalization of regulatory and cross-disciplinary procedures for preparing submissions to CTIS. Maria-Giovanna has a Ph.D. in Molecular Medicine and a diverse background in clinical operations, medical writing, and global regulatory affairs. She's passionate about the contribution that regulatory compliance and transparent information can make to the drug development process.

Agenda Sessions

  • Mastering the EU CTR and its transparency rules for organizational excellence

  • Evaluation of guidance, developing of best practices and leveraging innovative solutions to protect personal data and commercially confidential information (CCI)