MDTServices
Members
Prof Mira Pavlovic, MD
MDT Founder
Associate Professor, Pharmacological and Regulatory Science, Lisbon University, Portugal
Advisory Board member, NDA
Scientific Advisor, Clever-Access (https://www.clever-access.com)
Faculty Board Member, European Access Academy
Clinical dermatologist, Hospital Saint Louis, Paris, France
Previously:
Deputy Director for HTA, European collaboration and International affairs, HAS, France
SEED coordinator for EC
Head of Scientific Advice, ANSM, France
SAWP Vice-Chair, EMA
Prof Olivier Chassany, MD, PhD
Professor of Therapeutics, University Paris-Diderot, Faculty of Medicine, Paris, France
Director EA 7334 REMES, Patient-Centered Outcomes Research
Co-lead of a Master degree training on Therapeutics and clinical research: “From concept to proper use of drugs”.
Coordinator of the inter-university diploma DIU-FIEC (training of investigators and project leaders of clinical trials)
Prof Beatriz De Silva Lima, PhD
Professor and Dean at the University of Lisbon, Faculty of Pharmacy, Department of Pharmacological Sciences
Director of the Research Group on Pharmacological
and Regulatory Sciences at Lisbon University
Coordinator of the the Master in Regulation and Evaluation of Medicines and Health Products
Previously:
SWP Chair, EMA
CHMP member
IMI Scientifc Committe Chair
Carriers profiles
Mira Pavlovic is a founder of MDT services.
She is specialist in dermatology, in regulatory science and in health technology assessment for reimbursement purposes.
Mira has more than 25 years of experience as an expert in clinical and regulatory field. For 12 years Mira was serving as a Head of Scientific Advice at the French Medicines Agency (ANSM) and was member of several working parties at the EMA (Scientific Advice Working Party (SAWP), Efficacy working Party (EWP), Biosimilar Medicinal Products Working Party (BMWP)). As a Vice Chair of SAWP, she was involved in the review of more than 1000 scientific advices in 10 years. In 2010 Mira joined the Hauté Autorité de Santé (HAS), France as Deputy Director for Health Technology Assessment, and was in charge of European activities related to relative effectiveness assessment, in particular those coordinated by the EUnetHTA, such as early dialogues with developers, disease-specific guidelines and methodology of assessment for reimbursement purposes. Mira also coordinated the SEED (Shaping European Early Dialogues) project, financed by European Commission to support early dialogues between developers and HTA bodies as a permanent activity in Europe. Since September 2015 she consults on clinical drug development strategies and acts as member of the NDA and Clever-Access Advisory Board.Through European Access Academy, she is actively involved in EU HTA regulation implementation, notably joint scientific consultations and joint assessments.
Olivier Chassany is a specialist in gastroenterology and liver diseases and Professor of Therapeutics.
He teaches therapeutics, methodology and management of clinical research, critical reading of publications, ethical and regulatory aspects of clinical research, and methodology of clinical trials and patient-reported outcomes. For 13 years he was heading the Department of clinical research and development of Assistance Publique - Hôpitaux de Paris, an institutional sponsor of investigator-based clinical trials that promotes around 800 interventional and observational studies. Olivier participated in the new clinical trials regulation in France (European Regulation on clinical trials on drugs, French loi Jardé), such as the risk-based approach. He joined the Health Economics Clinical Research Unit of Hotel-Dieu Hospital, Paris in 2015. Olivier served as a Chairman of a Parisian Ethics Committee. He was clinical expert and member of several expert groups in regulatory drug agencies in France and in Europe (ANSM, EMA, HAS). Olivier has been investigator and coordinator of several therapeutic clinical trials, diagnosis test validation studies and of practice evaluation studies.
His main research topic is on Patient-Reported Outcomes methodology. He has developed Patient-Reported Outcomes questionnaires in many conditions. He chairs a clinical research team on patient reported outcomes at university Paris-Diderot and has developed academic collaboration in and outside Europe.
Beatriz Da Silva Lima is PharmD and PhD in Pharmacology and is full professor of Pharmacology and Pharmacotoxicology at the Lisbon University, Faculty of Pharmacy, and head of the Department of Pharmacological Sciences.
She is the Coordinator of the research Group of Pharmacological Sciences of the iMed.UL - RESEARCH INSTITUTE FOR MEDICINES AND PHARMACEUTICAL SCIENCES, where she heads also the research Group in Nonclinical Safety and Regulatory Science. Beatriz Silva Lima has 20 years of experience as an expert in nonclinical and regulatory science at Infarmed, Portugal and EMEA, UK. Up to July 2012, she has been member of the Committee of Human Medicines (CHMP), Committee of Advanced Therapies (CAT) and Scientific Advice Working Party (SAWP). She has been Chair of the Safety Working Party (SWP) and has been involved as Co-Deputy in ICH discussions on ICH M3R2, S6R1 and S1 guidelines on behalf of the European Commission. Since October 2012 she consults on nonclinical drug development strategies. She acts also a nonclinical expert and member of the NDA Advisory Board and since January 2014 up to end 2016 she has been Chairing the Scientific Committee of the Innovative Medicines Initiative (IMI). Areas of research: Regulatory Science Nonclinical Safety; Pharmacology of metabolic diseases