Member of the Secretariat for the Committee for Advanced Therapies, EMA
Dr. Lucia D'Apote, is currently a scientific administrator at the European Medicines Agency. She provides direct scientific, technical and regulatory support to the Committee for Advanced Therapies (CAT). As part of the Agency's advance therapy task force, she was a key contributor to the establishment of this innovative scientific committee and is now involved in the final drafting of the scientific and regulatory documents which lead to the full implementation of the ATMP Regulations.
Dr. D'Apote is an active member of the Agency's Innovation Task Force (ITF).
Dr. D'Apote has over 11 years experience in Regulatory Affairs working extensively with biotech products in various pharmaceutical companies. Before joining the Agency, she was working as regulatory affairs consultant at Kendle International and as Regulatory Affairs Manager in Pharmacia -Pfizer.
Dr. D'Apote holds a degree in Biology, a PhD in molecular biology with particular focus on genetic biomarkers in inherited disorders and a post-university specialization in Regulatory Affairs from the Universities of Bologna and Pavia, Italy.
Contribution to the panel discussion
Lucia D'Apote will participate in the discussion panel on 'Experience of the centralised procedure, a case study of the Regulation on advanced therapies.' She will contribute to the discussion by reporting on various initiatives put in place by the EMA and the CAT to promote dialogue between developers, manufacturers and regulators on scientific and regulatory challenges. These early interactions with Regulators are expected to improve the chance for SMEs to successfully develop and market ATMPs.