Tributo al Dr. Rafael Pérez Cristiá. Ex-Director General de la Agencia Reguladora de Medicamentos, Equipos y Dispositivos Médicos de Cuba (CECMED) / Tribute to Dr. Rafael Pérez Cristiá. Past Head and Director General of the Cuban Regulatory Agency for medicines and medical devices (CECMED)

RESUMEN

Dr. Pérez Cristiá was the Head and Director General of Cuba's Center for State Control of Medicines and Medical Devices (CECMED) from 2000 until his passing in June, 2020. Professional background Dr. Pérez Cristiá was a research pharmacologist and toxicologist by training, obtaining academic merit recognition by the Cuban Academy of Sciences. He held several positions as researcher and professor at the University of Medicine in Havana, Cuba and at the National University of Carabobo in Valencia, Venezuela. He also held various scientific appointments as President of the Cuban National Society of Toxicology, as honorary founding member of the National Toxicology Commission of Ecuador, permanent member of the General Council of Scientific Degrees in Health Sciences at the National Commission of Scientific Degrees, Ministry of Higher Education, Cuba. Dr. Pérez Cristiá was also appointed member of the MEDICC's Joint Academic Council. Apart from being a prominent scientist in his native Cuba, Dr. Pérez Cristiá became a referent in public health systems and policy both in Cuba and across the LATAM region. The following quote by Dr. C. William Keck, MEDICC's Executive Director summarizes Dr. Pérez Cristiá' s unanimous contribution to Cuba's public healthcare system "Dr. Pérez Cristiá was an important leader as Cuba, a small and resource-scarce country, became a global biotech powerhouse and biotechnology evolved as a key component of Cuba's public health system that provides universal health care for its citizens. Safe and effective medicines and technologies to all, especially the most vulnerable, is one of the country's more important public health strategies, in which, Dr. Pérez Cristiá was a key decision maker" 1 As a visionary and leader in regulatory systems and policy in Cuba, during his 21 years as Head and Director General of the CECMED, Dr. Pérez Cristiá implemented the culture and knowledge of regulatory sciences as a key component of the institution's core values and mission. Since, regulatory sciences, have become strategic tools to support the dialogue between the Cuban health agency regulators and the key Cuban stakeholders from the biotechnology industry, research and development institutions, public health advocates, among other relevant players impacting healthcare in Cuba.2 Dr. Pérez-Cristiá was a charismatic individual and great communicator. One of his personal dreams and professional desire was to keep motivating the regulatory professional and experts from Cuba and the Latin America so as to be fully engaged and inspired. Dr. Pérez Cristiá aimed for every regulatory professional to comprehend and internalize the goals and values of regulatory sciences. To this effect, Dr. Pérez Cristiá was constantly fostering collaborations within his team, as well as developing strategic regulatory networks at the regional Latin American level and globally. His professional vision was always linked the present and the future, respecting everyone's knowledge and opinions. CECMED's key milestones and accomplishments Under Dr. Pérez's leadership, the CECMED gained recognition from the Pan American Health Organization (PAHO) as one of the leading National Reference Authorities (NRA's) in the Latin American region for Medicines and Biologics. The PAHO classification system, granted CECMED the Level 4 in 2010 (highest classification).3 Below, is a list of other key regulatory milestones The CECMED served as General Coordinator of the PAHO Regional National Regulatory Authorities (NRA's) for two consecutive mandates (2014 - 2016). The CECMED served as General Coordinator of the National Center for the Regulation of Medicines of the Bolivarian Alliance for the Peoples of Americas (ALBAMED) (2009 - 2010). CECMED became a WHO National Regulatory Reference Center for Vaccines (2000). CECMED became Observer of the International Council Harmonization (ICH) (2016). CECMED became Associate Member of the International Coalition of Medicines Regulatory Authorities (ICMRA) (2021). In addition to the above accomplishments, throughout the past three decades, the CECMED's Quality Management System was also certified in several occasions by the Spanish Association for Standardization and Certification (AENOR) and the National Office of Standardization, becoming an IQnet member for the past 10 years.3 Furthermore, in September 2004 the CECMED became a member of the Developing Nations Vaccine Regulators' Network (DCVRN). The CECMED was able to become a network member as the Agency fulfilled the critical regulatory functions required by WHO, also meeting the criteria of having at least one prequalified vaccine manufacturer for supply via a United Nations agency. Apart from the above, the CECMED has gained recognition from all of the LATAM regional Regulatory Authorities and global Regulatory Agencies, such as Health Canada, US-FDA, The National Medical Products Administration (NMPA) of China, The Russian Regulatory Agency, Swiss Medic, the Paul Ehrlich Institute, among other. The CECMED's Office of Innovation A paramount contribution by Dr. Pérez Cristiá to public health and access to biopharmaceutical innovation in Cuba, (prospectively across the LATAM region) has been the creation of the CECMED's Office of Innovation in October, 2019. First of its kind in the Latin American region, the CECMED's Office of Innovation was built on a comprehensive regulatory framework with the aim to accelerate innovation enabling successful transition of novel products from research and development to clinical research, granting patients' early access to innovative medicines.4 This initiative has been propelled by the speed and complexity of new discoveries challenging both capacities and creative thinking of the Cuban regulatory authority, coupled with the change from a rigid, one-size fits all regulatory system to a more adaptive and flexible model (without compromising rigor) becoming an alternative, valuable and innovative regulatory tool. LATAM Endowed Chair in Regulatory Sciences Another key contribution linked to Dr. Pérez Cristiá's vision as a regulatory leader in the LATAM region has been the creation of a specialized training program in Regulatory Sciences for the regional Regulatory professional's community. Dr. Pérez Cristiá envisioned the creation of an Endowed Chair collaborating with renowned academic institutions in Cuba and across the Latin American region. Basically, the development of a professional training program to convey advanced training and expertise in drug regulation across the LATAM region, granting access to an international, multidisciplinary academic curriculum aimed at improving professional regulatory skills, teaching regulatory sciences as an imbedded culture based on an undergraduate and graduate curriculum. Furthermore, the Endowed Chair would allow access to expand the scope of regulatory research through publications, promoting joint academic initiatives as well as providing opportunities to collaborate with other institutions and regulatory agencies (both regional and global). Acknowledgements The authors of this tribute, are honored to have shared the contributions and legacy of Dr. Perez-Cristiá, Head and Director of the Cuban Regulatory Authority (CECMED) during his 20 years of tenure. Dr. Perez Cristia's commitment, professional legacy and teachings will permanently prevail, as he was unanimously regarded as a regulatory referent in public health in Cuba, across the Latin American region and globally.