Building Regulatory Preparedness in Latin America: What is the Relevance of Business Continuity Plans for Health Authorities?
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, with special focus on Brazil.
Maria Antonieta Tony Roman, MPharm
- Head Regulatory Policy Emerging Markets LATAM
- 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. 31 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, RPh
- Global Regulatory Policy Lead-LatAm
- Merck & Co., Inc., Panama
Leonardo Semprún is currently Senior Director, Global Regulatory Policy at MSD. In this role, Leonardo is responsible to define and execute a regional regulatory policy plan that addresses current and future needs, while also advocating for and anticipating regulatory change with LATAM-based regulators and multilateral organizations. He has worked with governments, regulators, trade bodies and other external stakeholders to shape regional regulatory policy.
Patricia Oliveira Pereira Tagliari, LLM, MPH
- Associate Director
- 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).