The subject area Regulatory Affairs ensures that the proof of the quality, safety and efficacy of the medicinal product is demonstrated to be in line with legal requirements for the purposes of marketing safe and efficacious medicinal products solely in the interests of public health.
- The European Pharmaceutical Legislation
- The regulatory institutions and other stakeholders
- Interaction of international regulatory agencies
- General requirements for the Common Technical Document (CTD), the Marketing Authorisation Dossier Modules 1 and SmPC, Module 2, Risk Management Plan
- Special legal provisions for biopharmaceuticals
- Orphan Drug Designation – provisions and procedures
- SME – provisions and procedures
- Principles of registration and certification of medical devices and device/drug combinations.
Founded in 2009, EUCRAF was conceived because there was a lack of an adequate training platform specifically on biopharmaceutical-related regulatory affairs and drug development. Based on an intensive dialogue with key stakeholders from authorities, universities and industry, a specialized program on biopharmaceuticals related regulatory affairs and drug development was developed for the first time in Europe.
Her main activities focus on consulting and strategic direction of projects in the area of Regulatory Affairs and Development for Europe and USA, actively participating in scientific advice, Paediatric Plans, Orphan Drug Designations, Development Plans, Centralized procedures, decentralized and mutual recognition in permanent contact with the regulatory authorities. She also has extensive regulatory experience in innovative, biological, biotech and advanced therapy.
She previously held positions in the pharmaceutical industry as Director of Regulatory Affairs, Vice-Director of R&D and Technical Director (Qualified Person).
Format and content of the marketing authorisation application: The Common Technical Dossier (CTD)
Module 1 of the CTD: General information
Labeling, Package Leaflet and Summary of Product Characteristics (SmPC)
As regulatory affairs manager, her main areas of expertise include providing scientific assessment in development of chemical drugs and biologics (including biosimilars and cell-therapy medicinal products), carrying out and overseeing CMC and medical writing of regulatory documentation (e.g. IMPDs, scientific advice briefing packages, registration dossiers, etc.), as well as conducting viability analyses and designing tailored roadpmaps for innovative medical devices and in-vitro diagnostics.Topic lectured:
Format and Content of the MAA Dossier: CTD and eCTD