Regulatory and Pharmaceutical Affairs Advisor
Doctor of Pharmacy
Specialization in European and International Regulatory Affairs for Health Products (AREIPS - Lille)
Thanks to her various professional experiences, Laure has acquired knowledge of registration activities in subsidiaries (Novartis) for oncology products, namely regulatory maintenance, responses to requests from the authorities and management of Product Information / Packaging materials / Risk Management Plans.
She worked on the implementation of a cohort ATU, preparing the application file, drafting the therapeutic use protocol and submission to the authorities. She also provided regulatory and competitive intelligence.
Prior to this, she joined the Macopharma pharmaceutical company for regulatory affairs activities on the parent company side. She oversaw the maintenance of MAs (submission of variations, publishing), the impact of Brexit, updates and control of regulatory texts / CDA, as well as contributing to drafting a PSUR in liaison with the Pharmacovigilance Department. Her remit also covered pricing and reimbursement files for approval to local authorities (generics and drugs for well-established medical use).
Laure joined ATESSIA in May 2020 as a junior consultant to strengthen the regulatory monitoring service. She collaborates with the other senior consultants on regulatory projects and participates in the firm’s consulting activities. She is also involved in the external publishing activities that ATESSIA offers its clients.