Co-Founder, Executive Regulatory Affairs Consultant, Alladvice Regulatory Consultants
Ex-regulator at the Medicine and Healthcare products Regulatory Agency (MHRA) in the UK as a Pharmaceutical Assessor of registration dossiers.
More than 20 years’ professional experience across Europe mainly in Regulatory Affairs and Product Lifecycle Management of Human Medicinal Products in different biopharmaceutical companies and business models.
She worked as Regulatory Affairs Head in TiGenix (currently Takeda) where among other projects with ATMP, she was actively involved in the successfully approval of the European Marketing Authorization of Alofisel (first authorization for an allogeneic cell therapy product in Europe).
In 2019, she established herself as an independent consultant and collaborated with Biopharmaceutical Companies and Public institutions in the field of ATMPs.
In July 2020, she co-founded Alladvice Regulatory Consultants, a Regulatory Consultancy created to support biopharmaceutical companies and public institutions, working with Advanced Therapy Medicinal Products (ATMPs) for human use, across all phases of the development, from non-clinical to post-marketing, to comply with regulatory requirements. .
Lecturer in Pharmaceutical Industry Masters and Congresses.
23 September 2021
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