Solving regional Regulatory Convergence challenges post COVID-19: Lessons learned after COVID-19: Global Challenges and the Future of Health Regulation Recommendations for an effective working model & cooperation for LATAM Public Health & Regulatory Health Authorities.
LATAM Regulatory Reference Authorities have turned into key decision makers in the Regulatory Convergence process implementing core initiatives such as the alignment of regulations through the implementation of accelerated pathways for the assessment of life saving drugs. These initiatives are driving the transformation of the LATAM regulatory paradigm through the design of new management models providing dependence, trust, recognition and cooperation between Regulatory Authorities creating strong regional decision makers able to take on new risks and challenges.
A key regional initiative, the CECMED's Office of Innovation is supporting regulatory actions to harness stronger regional Regulatory Systems assessing healthcare innovation for faster access to novel technologies. Through a culture embedded in regulatory sciences, the CECMED aims to assure that regulation is supporting the scientific processes needed to bring truly safe and effective quality innovative products to patients. The CECMED’s short term vision is to collaborate with other regional NRA’s to create the LATAM NETWORK of Innovation Offices ( cooperating with the EU Innovation Network) sharing experiences & knowledge to discuss case studies addressing best practices regarding emerging innovation.
Cuban Pandemic Algorithm Model – Public health and healthcare innovation - Yaquelin Rodríguez Valdés, Deputy Director, Cuban Regulatory Authority (CECMED)
How Can Latin American Regulators be Facilitators of Innovation - Lawrence Liberti, and Mario Alanis (CIRS- Centre for Innovation in Regulatory Science)
EU Regulatory Network: Cooperation to stimulate innovation with CECMED – LATAM Offices of Innovation - Andrea Laslop (AGES)
Support to medical innovation from the regulatory body perspective. The AEMPS experience - Cesar Hernández (AEMPS)
Q&A Session – Moderator, Silvia Bendiner Recommendations for an effective working model between Public Health Authorities & Regulatory Health Authorities (LATAM, EU, global?)
Understand the key role of the CECMED's Office of Innovation: its collaboration between industry, regional NRA's and EMA advancing access to healthcare innovation.
Convey how these novel regulatory initiatives can help advance healthcare innovation in the emerging LATAM markets.
Challenge NRA’s (Post COVID-19) with the creation of a Latin American Medicines Agency (ALAMED), an organization promoting mutual collaboration between Latin American sovereign states where pharmaceutical industry and governments align shared efforts, vision and public health benefits.