Professor Rogério Gaspar

Professor Rogério Gaspar is from Portugal and joined WHO on 6 January 2021 as the Director of Regulation and Prequalification Department (RPQ).  Rogério obtained his PhD in Pharmaceutical Sciences from the Catholic University of Louvain Belgium in 1991, after graduating as a pharmacist from the University of Coimbra, Portugal. 

He is a Full Professor at the Faculty of Pharmacy University of Lisbon (FFUL) suspending his contract at the end of 2020 to join WHO. At FFUL 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 a researcher and part of the Scientific Board until joining WHO.

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).

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). 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, became 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 in a diverse number of other platforms and working groups. From March 2021 to February 2024 co-chaired the regulatory working group of the mRNA technology transfer hub. From November 2022 to March 2024 Coordinated the WHO representation at the Global Training Hub in Biomanufacturing (GTH-B established between Republic of Korea and WHO). From January 2021 until March 2024 as Director of RPQ also coordinated the WHO activities in the implementation of WHA resolution 74.6 to strengthening local production of health and medical products. Since September 2022 has been representing MHP division in the HEPR and iMCM-Net frameworks lead by the WHO Emergencies. 

In 2002 lead the first ISO 9001 certification for INFARMED (Inspection and Licensing procedures). Since his arrival to WHO in January 2021 has coordinated the implementation within RPQ of a Quality Management System. 

Currently representing WHO at the Management Committee of ICH and vice-chair of the Management Board at the Uppsala Monitoring Centre (UMC). 

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Main publications since 2021, within WHO activities:

Philip R Krause, Thomas R Fleming, Ira M Longini, Richard Peto, Sylvie Briand, David L Heymann, Valerie Beral, Matthew D Snape, Helen Rees, Alba-Maria Ropero, Ran D Balicer, Jakob P Cramer, César Muñoz-Fontela, Marion Gruber, Rogerio Gaspar, Jerome A Singh, Kanta Subbarao, Maria D Van Kerkhove, Soumya Swaminathan, Michael J Ryan, Ana-Maria Henao-Restrepo – “SARS-CoV-2 Variants and Vaccines”, New England Journal of Medicine (2021), 385: 179-186 (2021)

Philip R Krause, Thomas R Fleming, Richard Peto, Ira M Longini, J Peter Figueroa, Jonathan AC Sterne, Alejandro Cravioto, Helen Rees, Julian PT Higgins, Isabelle Boutron, Hongchao Pan, Marion F Gruber, Narendra Arora, Fatema Kazi, Rogerio Gaspar, Soumya Swaminathan, Michael J Ryan, Ana-Maria Henao-Restrepo – “Considerations in boosting COVID-19 vaccine immune responses”, The Lancet, 398: 1377-1380 (2021)

Philip R Krause, Narendra Arora, William Dowling, César Muñoz-Fontela, Simon Funnell, Rogerio Gaspar, Marion F Gruber, Adam Hacker, Ana Maria Henao-Restrepo, Stanley Plotkin, Helen V Rees, Dean K Smith, Soumya Swaminathan – “Making more COVID-19 vaccines available to address global needs: considerations and a framework for their evaluation”, Vaccine, 40: 5749-5751 (2022)

Marco Cavaleri, Marion Gruber, Rogerio Gaspar, Mimi Darko – “Meeting regulatory criteria and seeking licensure: medicines development before and during public health emergencies”, Chapter 6 in “Principles and Practice of Emergency Research Response” Edited by Elizabeth S. Higgs and Robert A. Sorenson, Springer International Publishing, pp 129-146 (2024)

Alireza Khadem Broojerdi, Anna Laura Salvati, Mohammed Refaat Abdelfattah, Razieh Ostad Ali Dehaghi, Hiiti B Sillo, Rogerio Gaspar - “WHO-listed authorities (WLA) framework: transparent evidence-based approach for promoting regulatory reliance towards increased access to quality-assured medical products”, Frontiers in Medicine (Regulatory Science), 11 (2024)