Medical Information Head for the Americas Region, at Takeda. Nineteen years of experience in the Pharmaceutical Industry, holding leadership positions in Pharmacovigilance (Wyeth - currently Pfizer, Janssen and Shire - currently Takeda), at the regional level (Latin America). Responsible for implementing the Medical Information regional structure in Latin America, at Shire (now Takeda) and, in the last 3 years, is leading Latin America, US and Canada. Was responsible for the Medical Information integration activities between Shire and Baxalta and, recently, part of the Medical Information leadership team at Takeda.

Industrial Pharmaceutical Chemist with 17 years of experience in the pharmaceutical industry. Founder and Member of #PharmacovigilanceEnEspañol. Founder of "JBA Farmacovigilancia". Advisor of the Pharmacovigilance Institute. Member and Mexico´s ambassador of the International Society for Pharmacoepidemiology (ISPE). Member of the LinkedIn program #LinkedInCreators. Pharmacovigilance Professor for Latin America. Ambassador for LATAM of the Global Pharmacovigilance Society (GPS). Invited coordinator of the Pharmacovigilance academic program at UNIBE. He collaborated with companies such as Wyeth, GlaxoSmithKline, Merck Sharp & Dhome and Pfizer. Currently, he works as a Global Auditor of Pharmacovigilance for Novartis.

Daniela Bravo is the Regulatory Policy and Intelligence leader for Latin America at Abbvie. She has a Master and a PhD degree in Health Sciences and previous experiences in regulatory affairs working at the Brazilian Health Authority (Anvisa) and the pharmaceutical industry.

Arthur is an experienced Pharmacist with more than 16 years of experience in Patient Safety & Pharmacovigilance. Currently Country Safety Head Back-Up at Sanofi Brazil. His carreer started at Takeda Brazil, where he acted in roles of increasing responsibility within local/regional/global PV operations organization (including oversight of ICSRs management, PBRER management, RMP management, Audits/Inspections, Pharmacovigilance Agreements, etc). Arthur also worked for CROs (IQVIA (formes Quintiles) and LabCorp (former Covance)), including Local, Regional and Global Projects for Pharmacovigilance and Patient Safety.

Experienced Medical Marketing Manager with a history of working in global, reginal and local teams in the healthcare industry in LATAM. A healthcare enthusiast, passionate patient advocate, I have recently specialized in helping patients by providing support in communication skills, resources, and guidance. With my knowledge of the industry, and personal experiences as a patient, I have helped patients get their voices heard in the industry. I have worked with organizations such as the FAST LATAM (Angelman Syndrome), Sickell Cell Disease, Rare Disease, among others. My latest work is a Voice of Patient Review, which is an FDA-led Patient-Focused Drug Development (PFDD) Report, where the FDA recognizes the value of gathering patient input.

Raphael has more than 16 years of experience in Pharmacovigilance, beginning at Sanofi Brazil, where he acted in roles of increasing responsibility within local PV organization, responsibilities including oversight of case management, PSUR management and RMP management. Raphael also worked for Johnson & Johnson as associate manager, with responsibility for 18 countries within Latin America in processes like PSURs, PV Agreements, oversight of reporting to Health Authority and of contracts with vendors and business partners. Also worked at MSD Brazil as Associate Director with experience in PV and Quality & Compliance for PV and Regulatory for Americas. Since Aug.2022 Raphael is Head of PV Brazil at Roche.

Flavia is the Regulatory Advisor for Latin America in Global CMC at Pfizer since 2017. She holds accountability for partnering with manufacturing organizations and Regulatory Affairs while providing regional regulatory expertise to CMC Product Strategists, addressing strategic issues, contributing to the development of policies and positions on draft regulations and external engagement on CMC topics. Based in Brazil, she has over 20 years of experience in Quality, Regulatory and CMC areas and held leadership positions in Regulatory Conformance, Quality Operations and Regulatory Affairs.

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.

Susan Koepke is a Regulatory Affairs professional with more than 25 years of experience in pharmaceutical industry. She works for EMD Serono Inc, healthcare business of Merck KGaA, Darmstadt, Germany. She is the Regulatory Affairs Head for Latin America based in Miami, FL, USA being responsible for innovative pipeline delivery as well as for life cycle management activities of established products in Latin America.

Dr Liberti has worked in pharmaceutical regulatory affairs, communications and clinical R&D for the past four decades. From 2009 to 2021 he has served as the Executive Director of CIRS (the Centre for Innovation in Regulatory Science, Ltd, forming part of Clarivate Analytics). He has been actively involved in promulgating best practices in the regulatory aspects of medicines development, especially in the emerging markets. He received his doctorate in International Regulatory Policy through the WHO Collaborating Centre for Pharmaceutical Policy and Regulation, Utrecht University, where his research centered on expedited regulatory pathways with applicability in the emerging markets. He is a volunteer with the nonprofit Erudee Foundation.

Mercedes is originally from Mexico and holds a bachelor’s degree in economics, a master’s degree in Inter-American studies and PhD work in Latin American Culture and Education and PhD work in Organizational Leadership studies. Mercedes has trained and presented compelling information to National Cancer Institute directors throughout Latin America and influenced their participation in clinical research. Now, as a Regional Operations Manager for Latin America, Mercedes is focused on the development of Clinical Research professionals in Latin America and is confident in her capacity to convocate and connect with people of different cultures and interests to continue growing the network of clinical research sites and CRCs.

Elkiane is a Health Regulation Expert of the Brazilian Health Regulatory Agency - ANVISA. With 19 years of experience, she has served as a reviewer and advisor at ANVISA, initially in the Toxicology Office, and subsequently in the Biological Products Office. Recently, she has assumed advisory roles within ANVISA, first within the Directorate and presently in the International Affairs Office. She has been a member of ICH Q12 Expert Working Group and currently o currently serves on ICH Q6 as a Rapporteur Supporter. She holds a Pharmacy and Biochemistry Degree with specialty in Pharmaceutical Industry, a Master’s degree in Toxicology, Postgraduate certificates in Toxicology, and in Health Regulation.

Over 15 years of experience in law, finance, and corporate compliance. Worked for numerous small and mid-sized law firms, renewable energy companies, before launching MGC Associates LLC, a fully integrated pharmaceutical and medical device consulting partnership. Current area of focus and specialty is regulatory and quality sciences pertaining to medical devices, in vitro diagnostics, and digital health technologies in Latin American and Caribbean regions. She is currently working towards her Doctorate in Regulatory Sciences (DRSc) at USC.

Pharmacist, She is currently Director of Technical Regulatory Affairs and Inovation at Sindusfarma. She has worked for 17 years in the pharmaceutical industry. Specialist in Project Management. She acts in defense of the pharmaceutical industrial sector and coordinates regulatory convergence issues including Pharmacovigilance. She is a member of the Brazilian Pharmacopoeia Management Committee and is responsible for the interface with Anvisa representing associated companies.

Pharmacist, post graduated in Marketing and Business Management. 15+ years’ experience in pharmaceutical industry supporting business with technical and medical expertise. Worked in several areas (Medical, Pharmacovigilance, Quality, Compliance, Customer Service and Marketing) in different industries such as Sanofi, Sanofi Pasteur, Biogen and Local Brazilian CRO. Joined PPD in June 2017 as associate director and as of February 2019, director of operations, working with different clients in Latin America and US.

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.

Professional in Pharmaceutical Sciences with 20 years of experience, 15 of them in the sector of health regulation of medicines; focused mainly on the management of international cooperation from National Regulatory Authorities, networking, project management, negotiation and implementation of agreements, construction and monitoring of action plans, intellectual property and its linkage with access to medicines and other health technologies and the preparation and publication of scientific publications.

Ms. Pineda joined the U.S. FDA office in Mexico on March, 2013. She has a BSc on Chemistry, Pharmacology and Biology from the UNAM and a MSc on Toxicology from the CINVESTAV/IPN. She started her professional career in the pharmaceutical industry in the production area. In 2001 she joined the Mexican Government as Head of the Toxicology Department at the Ministry of Health, participating in the development of the risk assessment area. For 10 years Ms. Pineda was Manager of International Affairs on Drugs at (COFEPRIS), where she represented and coordinated COFEPRIS’ participation in international fora on drugs, medical devices, dietary supplements, cosmetics, toxic substances and pesticides, as well as developed cooperation agreements.

Duglas holds a Bachelor of Science degree in Biology with specialization in Molecular Biology, Biochemistry and experience in preclinical biochemical research. He adds to his career more than 12 years of experience in Regulatory Affairs in multinational companies such as P&G, J&J and Roche. With an extensive knowledge of the LATAM regulatory landscape for consumer products, medical devices and pharmaceuticals, he recently has worked on strategic approaches to cooperate with regulators to strengthen the regulatory systems and has played leadership roles in industry associations like FEDEFARMA. Duglas currently holds the position of Head of LATAM Regulatory Policy part of the Global Regulatory Policy & Intelligence group at Roche Diagnostics.

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 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. Leonardo' work in the industry spans over 20 years, across regulatory, quality, intellectual property and policy functions

As Head of Clinical FSP for The Americas at Labcorp, Ricardo oversees clinical teams of professionals in over 12 countries in North and Latin America. With over 20 years of experience in clinical research, he started his career working in Regulatory and Quality areas, then moved to Clinical Monitoring and Project Management. In 2009 he created from scratch and managed a Site Management Organization in Mexico that leaded him to jump to the CRO business in 2011. Passionate about developing professionals and innovative applications for clinical research, his career has been a complete journey. He regularly participates as speaker in different congresses and as trainer in Global Events presenting Latin American Clinical Research Advantages.

Patient Safety Manager at PGA Farma responsible for supporting activities related to patient safety, in clinical trials and post marketing activities, for different pharmaceutical companies with the objective to help them reach their internal process with high performance and quality according to requirements from differenece healthy authorities. Professional with over 20 years of experience in pharmacovigilance in national and international pharmaceutical industry, working on different kind of operations like Pharmacovigilance, Technovigilance, Cosmetovigilance and Nutrivigilance owith process related to clinical development and postmarketing.

Susan Zavala is a Pharmacist with more than 10 years of experience, mainly in regulatory affairs. She has studied a Master in Biotechnology, as well a Master in Pharmaceutical Legislation and Intellectual Property. Over her more than 7 years at DIGEMID, she has work as a CMC reviewer of biological products, also, she has participated in the elaboration of regulation and procedures related to the sanitary register. Susan has participate as a speaker for several international events organized by MFDS, CASSS, DIA and PAHO. Currently, she is the coordinator of the reviewer CMC team of biological products.