On February 2, a decree defined the format of the report to be sent to the Minister of Health by each competent authority concerning the implementation of the Loi Encadrement
The Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders of January 10, 2022 (EMA/419571/2002. Version 2) provides important clarifications regarding the shared role of the MAH and the
We support you at every stage in the process of optimizing your organization and improving your Quality Management System, from one-off consultancy assignments to long-term support. Our aim is to be responsive, pragmatic and operational. We can also offer you out-sourcing services for some of your activities.
- Compliance with the law governing benefits and transparency of links of interest<\/p>\n <\/div>\n
In 2009, Marie-Christine Belleville and Laurent Clerc set up Belleville PharmExperts to offer manufacturers a highly flexible approach, at the heart of their companies and projects. Drawing on both their operational and managerial experience, they offer healthcare companies the benefit of their regulatory expertise, quality culture and in-depth knowledge of software tools.
Member of the ‘Académie nationale de Pharmacie’ (Pharmaceutical and legal sciences section applied to the industrial environment of medicines and other health products), author and coordinator of the "Indisponibilité des médicaments" report (June 20, 2018) and the "Risques sanitaires et éthiques liés à l'innovation thérapeutique" report (October 2005). Head of the AFAR Promotional Information Charter Working Group since its creation in 2005 and Co-Head of the Professional Practices Charter Working Group (medical devices). A pharmacist and former hospital intern, Marie-Christine Belleville has over 40 years' professional experience in the pharmaceutical industry, within the industry, the professional body (LEEM) and consulting firms in pharmaceutical regulatory affairs and quality management (25 years). She holds a post-graduate diploma (DESS) in drug control and plant drugs, and a post-graduate diploma (DESS) in pharmaceutical legislation and ethics.
A Doctor of Pharmacy with a post-graduate diploma (DESS) in Health Law, a DESS in Quality Assurance and an Executive Master of Business Administration from ESCP-Europe, Laurent Clerc has more than 25 years' professional experience in the pharmaceutical industry and hospital structures, in pharmaceutical regulatory affairs consultancies and as manager of a software publisher specializing in Compliance. For 10 years, he set up and managed the ISO 9001 Quality Management System for this software publisher. He also has practical experience of organizing and managing outsourcing services for the healthcare industry.
In addition to the regulatory requirements we cover for your structure and your healthcare products, depending on their status (drug or medical device), we offer you the following privileged partners to enable you to contact a network of experts who share our values of responsiveness, rigor and pragmatism.
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