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The Role of Regulatory Sciences from the Perspective of the Cuban Medicines Regulatory Agency: The Impact of COVID-19 in Promoting Innovation, Cooperation and Scientific Thinking.
Romeu, Belkis; Rodríguez, Yaquelín; Bendiner, Silvia.
  • Romeu B; Secretary Executive Office of Innovation, Center for State Control of Medicines and Medical Devices (CECMED), Havana, Cuba. belaromeu@cecmed.cu.
  • Rodríguez Y; Former Deputy Director, Center for State Control of Medicines and Medical Devices (CECMED), Havana, Cuba.
  • Bendiner S; WESSX. Inc, Amsterdam, The Netherlands.
Ther Innov Regul Sci ; 55(5): 1014-1018, 2021 09.
Article in English | MEDLINE | ID: covidwho-1210760
ABSTRACT
The authors aim to familiarize the reader with the Center for the State Control of Medicines, Medical Equipment and Devices (CECMED) and the agency's perspective regarding the development and implementation of regulatory sciences as an interactive tool to promote cooperation and scientific thinking. The authors share their viewpoint on the preparedness of Latin American regulatory agencies by assessing innovation (i.e. novel biopharmaceuticals, vaccines, etc.), analyzing the challenges which are impacting healthcare and patients, and posing suggestions for a collaborative regional and international approach. To conclude, the authors' share recommendations for the implementation of regional initiatives aimed at supporting regulatory science, with the goal to promote the exchange of scientific cooperation as a vital element to maximize regulatory skills and competencies.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Vaccines / COVID-19 Type of study: Experimental Studies Topics: Vaccines Limits: Humans Country/Region as subject: Cuba Language: English Journal: Ther Innov Regul Sci Year: 2021 Document Type: Article Affiliation country: S43441-021-00300-0

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Vaccines / COVID-19 Type of study: Experimental Studies Topics: Vaccines Limits: Humans Country/Region as subject: Cuba Language: English Journal: Ther Innov Regul Sci Year: 2021 Document Type: Article Affiliation country: S43441-021-00300-0