Health Authority Forum
The Health Agency Forum will pro-actively encourage LATAM regional Regulatory Authorities and country/specific healthcare systems to engage with EU Regulators towards optimizing reliance and regulatory capacities for the implementation of accelerated regulatory pathways.
A core objective of this session is to generate recommendations for the implementation of common global standards & requirements based on the EU mutual recognition model (in place since 2004), adopting reliable regulatory procedures, implementing guidance documents, regulatory tools based on scientific exchange and collaboration.
The aim is to accelerate the drug review, evaluation and approval process in the LATAM region granting patient access to innovative therapies, such as, drugs for life saving diseases, for orphan indications, debilitating and chronic diseases.
EU Regulatory Agency keynote speakers will share the regulatory landscape and regulatory practices comparing tools available in the EU which could benefit the optimization of reliance initiatives across the Latin American region.
The LATAM keynote speakers will convey regulatory initiatives and programs, including an overview of country specific regulatory pathways currently implemented and/or under evaluation for the introduction of novel therapies
Silvia Bendiner, Director BD & Regulatory Affairs Latin America, ICON plc
Rafael Pérez Cristiá, MD, PhD, Head, Cuban Regulatory Agency (CECMED)
Pros and Cons of a Centralized Regulatory Network
María Concepción Yerro, MD, PhD, Spanish Agency for Medicines and Medical Devices
Regulatory challenges enabling early access to patients - EU Perspective
Andrea Laslop, MD, Head of Scientific Office, Austrian Medicines and Medical Devices Agency
Building Transatlantic Bridges: Innovation Cooperation Between PEI, Germany and CECMED, Cuba
Bettina Ziegele, MA, Head of Innovation Office, IP-Management
Regulatory Sciences Landscape - Brazillian Perspective on Optimizing Reliance and Regulatory Capacities
João Paulo Ortega Terra, Master in Diplomacy, Head Office of International Affairs, Brazilian Health Regulatory Agency, ANVISA
Convergence as a Strategy in the Regulatory Process
Valeria Teresa Garay, Deputy Director, International Relations Office, ANMAT, Argentina
LATAM - Optimizing Reliance and Regulatory Capacities
Julio Sanchez Y Tepoz, Esq, President of ALó ProSciences, Former Commissioner of Health, COFEPRIS, Mexico