Presenters
Cammilla Horta Gomes, MA, MPharm
Latam Regulatory Policy Lead , Roche, Brazil
Specialist in Global Health and Health Regulation, with a Master’s Degree in Development and International Cooperation. Broad experience in regulatory policy, both as regulator in ANVISA and industry, leading or contributing to bilateral and multilateral negotiations, harmonization and convergence initiatives. Specialized knowledge and activities in liaising with government agencies, international and regional organizations, industry and other stakeholders in the area of health regulation. Current role in Roche as Regulatory Policy Lead for Latin America.
Maria Antonieta Roman, MPharm
Head Regulatory Policy LaCan, Novartis, Mexico
Degree in Pharmacy, Master of Science (pharmacy) UNAM; Diploma in Clinical development and regulatory affairs, Universidad Anahuac; diploma in public health by the Swiss School of Public Health. 32 years of experience in various areas in the Pharmaceutical industry like R&D, quality, manufacturing, regulatory affairs and teaching. She has contributed in: BIRMEX, CDC, USA, Boehringer Ingelheim, Sanofi Pasteur and Novartis where she currently holds the position of Regulatory policy head, LATAM; has collaborated with regulatory authorities and associations of the pharmaceutical industry in the review and preparation of regulatory documents; coordinator of the Regulatory Affairs Committee of the Swiss-Mexican Chamber of commerce.
Leonardo Semprun, PharmD
Global Regulatory Policy Lead-LatAm, MSD, Panama
Leonardo Semprún is the Global Science & Regulatory Policy Leader for Latam at MSD, where he leads the definition and execution of regulatory policy plans that address the current and future needs of the region. With over 20 years of experience in the industry, he has held key roles in regulation, quality assurance, intellectual property, and policy, collaborating with governments, regulators, academia, and multilateral organizations to influence regional policy-making. Additionally, he is co-chair of the Regulatory Affairs and Pharmacovigilance group at FIFARMA, where he drives important initiatives in the field of regulation and drug safety.
Patricia Oliveira Pereira Tagliari, LLM, MPH
Associate Director of the Second Directorate, ANVISA, Brazil
Patricia Oliveira Pereira Tagliari holds a master’s degree in Public Health (Global Health and Health Diplomacy) from the National School of Public Health (2014), specializations in Health Regulation and Surveillance (2010) and Health Law (2007), both from Fiocruz, and a degree in International Affairs from the University of Brasilia (2004). She is currently a government employee, specialist in health regulation and surveillance, at the Brazilian Health Regulatory Agency - Anvisa. From April 2020 to the present date, Ms. Tagliari has served as Associate Director at Anvisa. Prior to that, she served as Advisor at Anvisa’s Office of Inspection and Health Surveillance and as the Head of Anvisa's International Affairs Office.
Renata de Morais Souza
Specialist in Health Regulation and Surveillance, ANVISA, Brazil
Renata is a specialist in health surveillance - management and regulation. She has worked in the Brazilian Health Regulatory Agency (Anvisa) since 2005. She was manager of the Controlled Drugs Office of Anvisa from 2012 to 2020. Currently, she is assessor in the International Affairs Office of Anvisa. In 2022, she was member, as co-leader, of the Crisis Management Group of International Coalition of Medicines Regulatory Authorities (ICMRA).
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