Mira’s expertise lies in joint regulatory and HTA advice, recommending pharmaceutical companies of all sizes on the direction and corrective actions needed to meet the needs of both regulators and payers in the major markets. Mira’s main advisory activities are regulatory, HTA and combined scientific advice/early dialogue, understanding disease-specific guidelines, evidence data generation with and methodology of assessment for regulatory and reimbursement purposes.
Mira is a practicing physician in Paris and Associate Professor for regulatory and HTA science at Lisbon University.
Key Areas Of Expertise
- Clinical development
- Medicinal products, medical devices, diagnostics and co-diagnostics for marketing authorization and reimbursement purposes in different fields of medicines
- Methodology of development
- Study designs, choice of endpoints and comparators to support regulatory and relative effectiveness claims
- Detailed knowledge of the European approval and reimbursement systems including European Medicines Agency (EMEA), HAS and other HTA agencies in Europe
- Patient relevant endpoints and health-related quality of life assessment for regulatory and HTA purposes
Before Joining The NDA Advisory Board
Mira was the Deputy Director for Health Technology Assessment at the Hauté Autorité de Santé (HAS) in France, in charge of European activities related to health technology assessment (HTA), those coordinated by the EUnetHTA.
Mira was also involved in regulatory science for more than 10 years. She was the Head of Scientific Advice Unit at the French Medicines Agency (AFSSAPS), Vice-Chair of Scientific Advice Working Party (SAWP), a member of Efficacy Working Party (EWP), and Biosimilar Medicinal Products Working Party (BMWP) at the EMA.
M Berntgen, A Gourvil, M Pavlovic, W Goettsch, HG Eischler, FB Kristensen. Improving the contribution of regulatory assessment reports to health technology assessments--a collaboration between the European Medicines Agency and the European network for Health Technology Assessment. Value in Health 2014 (17), Issue 5, 634-641.
M Pavlovic, C Teljeur, B Wieseler, M Klemp, I Cleemput and M Neyt on behalf of EUnetHTA. Endpoints for relative effectiveness assessment (REA) of pharmaceuticals. International Journal of Technology Assessment in Health Care 2014(11):30(5):508-13
S Kleijnen et al. Improving the contribution of regulatory assessment reports to health technology assessments – A collaboration between the European Medicines Agency and the European network for Health Technology Assessment. Value in Health 2014(07):17(5):634-41
M Pavlovic, J Garnier, I Durand-Zaleski, et les participants à la table ronde N°3 de Giens XXXI: Survie sans progression, survie globale et qualité de vie: quel intérêt au plan médico-économique en oncologie? Thérapie 2016 (71), 59-67
Professor Mira Pavlovic-Ganascia, MD