Dr Rogerio Gaspar

Dr. Rogério Gaspar from Portugal joined WHO on 6th January as the Director of Regulation and Prequalification Department.  Rogério obtained his PhD in Pharmaceutical Sciences from the Catholic University of Louvain Belgium in 1991, after a graduation as pharmacist from the University of Coimbra Portugal. 

He worked as a Full Professor at the Faculty of Pharmacy University of Lisbon until the end 2020, where he was Head of Department and President of the School Council. He was previously leading the Nanomedicine Drug Delivery Systems research group within the Research Institute for Medicines (iMedUL,which he cofounded in 2007), before moving in 2017 to the Institute of Bioengineering and Biosciences where he was until now researcher and part of the Scientific Board.

His research focus, at the University of Coimbra and the University of Lisbon, was in the area of new therapeutic strategies using liposomes, polymeric biodegradable nanoparticles, and polymer therapeutics, in several therapeutic areas and more recently in the use of targeted delivery systems for combination therapy in cancer, including nucleic acids delivery, with publications in relevant journals (for reference see ORC ID 0000-0002-5950-0291).

His most recent publication was in August 2020 on “Non-biological Complex Drugs: Complex pharmaceutical in need of individual robust clinical assessment before any therapeutic equivalence decision”, published in Frontiers in Medicine (Regulatory Science).

He was a co-founder of the Master’s degree in Regulatory Science at the University of Lisbon (RAMPS), started in April 2002 and still very active, including relevant international participations.

In parallel to his academic career as a researcher, professor and holding academic responsibilities (e.g. Vice Rector and other academic duties), he had a long standing contribution in the regulation of medicines at national regional and international levels, starting at the early phase of the European Medicines Agency in 1995 (London, UK), as a Vice President of the National Medicines Committee (Portugal) and also as a member of EMA’s CPMP and quality working party (QWP). 

He has also taken leadership and participation roles in different activities both at the EU-Japan MRA, training in GMPs and Quality Management System for ASEAN National Regulatory Authorities, both public and private sector in Portugal, President of the Portuguese Society of Pharmaceutical Sciences (SPCF, 2016-2020) and both at the Executive Committee of the European Federation of Pharmaceutical Sciences (EUFEPS, 2009-2013 and 2016-2020, including Vice-President (VP) 2011-2012 and 2018-2020) and leadership of the EUFEPS Regulatory Science Network (2010-2019) as well as VP of International Pharmaceutical Federation (FIP) Special Interest Group (SIG) in Regulatory Science (2011-2014). Other participation in international collaboration, merging scientific domains and regulatory science, include several countries in the Americas, Africa and Europe.

Rogério was previously a member of the management board of EMA and VP of the management board at Portugal’s NRA (INFARMED). In Portugal, he was responsible for the redrawing and installation of the national Official Medicines Control Laboratory (OMCL) and also lead the first ISO 9001 certification for INFARMED (Inspection and Licensing procedures). He had also a relevant participation in activities against medicines counterfeiting and from 2000-2002 lead the participation of Portugal within International Narcotics Control Board (INCB) (UN, Vienna). 

Since joining WHO become also member of the board at the Uppsala Monitoring Center (UMC), co-chair of the Regulatory Advisory Group (RAG) at the COVAX facility (ACT-Accelerator) and member of the Council of Regulators at DIA, as well as representing WHO at a diverse number of other platforms and working groups.