Lucie CLOUIN-MOTHE

Lucie CLOUIN-MOTHE leverages over 20 years of experience in regulatory affairs to support healthcare stakeholders in managing their regulatory and pharmaceutical projects.

As Director of Operations and Senior Consultant in Regulatory and Pharmaceutical Affairs at ATESSIA, Lucie coordinates the firm’s activities, contributing to the implementation of tailored solutions to ensure compliance and operational efficiency in pharmaceutical and regulatory matters. Her role encompasses comprehensive support for both parent companies and their French subsidiaries, focusing on registration, post-marketing authorization (MA) follow-up, product quality management, and the application of regulations related to product commercialization (such as product information updates, implementation of MA variations, management of shortages, and the establishment of safety stocks, etc.) while maintaining a 360° view of the marketing authorization holder’s regulatory obligations.

Her expertise covers the entire product lifecycle, from early-stage access (early access, compassionate use, compassionate prescription frameworks) to product registration and quality management, including compliance with regulations on advertising, promotion, and the Sunshine Act. She is well-known for her compliance expertise, particularly in promotional control, the boundary between promotional and non-promotional materials in communication support and field activities, as well as issues related to the HCPs Anti-Gift Law and the promotional information charters.

Lucie brings specialized expertise in regulatory audits, whether related to the marketing authorization holder’s activities, activities linked to promotional information charters, or those involving healthcare professionals in France. She also conducts due diligence for MA acquisitions, as well as internal and subcontractor audits, ensuring compliance and quality in both internal and external processes.

Additionally, Lucie leads training sessions in her areas of professional expertise (notably advertising, charters, drug shortages, and relationships with healthcare professionals and influencers), where she shares not only theoretical knowledge but also practical, operational aspects of implementing various regulations, providing a pragmatic and illustrated view through case studies.

With a background at international pharmaceutical companies such as Grünenthal, Merz Pharma, and Takeda, Lucie has held roles including Interim Responsible Pharmacist and Head of Regulatory Affairs. She has overseen projects covering therapeutic areas such as oncology, cardiology, and gastroenterology, managing the registration of medicines and medical devices as well as the validation of promotional materials. This multidisciplinary experience has allowed her to gain deep expertise in the management of marketing authorization dossiers and compliance audits.

An active member of several discussion groups, including AFAR, Lucie actively contributes to the evolution of regulatory practices and the development of innovative solutions for healthcare stakeholders.