Perspectiva general

Forum: September 25-26

DIA’s 2024 Latin America Annual Meeting offers unparalleled opportunities for networking and knowledge sharing with key stakeholders to advance and implement life sciences R&D initiatives in Latin America and the Caribbean. This year, session tracks on Regulatory/Clinical, Safety and Pharmacovigilance, and Medical Affairs and Scientific Communications (MASC) expand the scope of the meeting, with cross-track sessions facilitating discussions on key connection points across these areas to promote collaboration and synergy within organizations.

Join the conversation on multi-regional cooperation, global harmonization and reliance, lessons learned, and best practices. Don’t miss the chance to be part of this pivotal event, where innovation and cooperation come together to shape the future of healthcare in the region. Engage with experts from ANMAT, ANVISA, ARCSA, COFEPRIS, DIGEMID, DINAVISA, European Medicines Agency, FDA, Ministry of Health of Costa Rica, Ministry of Public Health – Uruguay, South African Health Products Regulatory Authority (SAHPRA), and more!

*The primary language is English, however simultaneous interpretation in Spanish and Portuguese will be available during this meeting.

Need Approval in Order to Attend?

Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.

Download Letter

Participant Testimonials

The agenda was prepared including topics of great importance and current affairs. The exchange between the participants is very enriching and gives the possibility of listening first-hand to the experience of prestigious speakers. - Lisette Pérez Ojeda - CECMED, Colombia

It is an important event to share information/experiences, to access the current status and opportunities, to develop ourselves and to implement new strategies/skills/information into the work. – Patricia Dias - LEO Pharma, Brazil

Featured

Want to learn more about Latin America Annual Meeting? You've come to the right site!

Check out the great content lined up for the Regulatory/Clinical, Safety and Pharmacovigilance, and Medical Affairs and Scientific Communications (MASC) tracks at Latin America Annual Meeting.

Welcome Video in English

Conozca el excelente contenido preparado para las sesiones sobre Regulación/Clínica, Seguridad y Farmacovigilancia, y Asuntos Médicos y Comunicaciones Científicas (MASC) de lo Latin America Annual Meeting.

Confira o ótimo conteúdo preparado para as áreas de Regulamentação/Clínica, Segurança e Farmacovigilância e Assuntos Médicos e Comunicações Científicas (MASC) no Latin America Annual Meeting.

Welcome Video in Spanish/Portuguese

¿Quiénes deben asistir?

Professionals interested in:
- Academia
- Benefit-Risk Assessment and Communication
- Clinical Research and Development
- Clinical Operations
- CROs/Vendors
- Document Management/eSubmissions
- Drug Regulation
- Drug Safety/Pharmacovigilance
- Field Medical
- Global Submission/Project Management
- Government Affairs
- Manufacturing
- Medical and Scientific Affairs
- Medical Call Center Environment
- Medical Communications
- Medical Information
- Medical Product Safety Assessment
- Medical Science Liaisons
- Medical Writing
- Pharmacoepidemiology
- Policy and Intelligence
- Post-Market Studies
- Quality Assurance and Compliance
- Real-World Evidence
- Regulatory Agencies
- Regulatory Affairs, Operations, and Strategy
- Research and Development
- Risk Management, including Risk Evaluation and Mitigation Strategies (REMS)
- Strategic Sourcing/Planning

Objetivos de aprendizaje

Upon completion, learners should be able to:
- Understand and distinguish key elements and strategies for strengthening regulatory systems
- Identify and analyze challenges, obstacles, and potential solutions or approaches in the implementation of Good Regulatory Practices (GRP) and the adaptation of ICH guidelines in Latin America
- Explore opportunities and strategies for collaboration among public, private, and academic sectors to advance regulatory agendas, promote regulatory harmonization, and foster knowledge and experience sharing among stakeholders
- Gain insights into the Pharmacovigilance and Technovigilance landscape in Latin America, including regulatory expectations, inspection trends, and opportunities for process alignment and improvement
- Identify and implement innovative techniques for presenting data effectively, evaluate various channels for data presentation, and explore decision-making practices necessary for the practical implementation of reliance models and risk prioritization
- Define AI and explore its practical applications in Medical Information (MI) activities, analyze real cases of AI implementation, and evaluate the digital landscape, including legal and compliance considerations related to AI and technology use
- Understand the importance of integrating the patient's perspective into pharma industry strategies
- Identify opportunities for e-labeling initiatives
- Recognize the significance of electronic Common Technical Document (eCTD) in regulatory submissions
- Discuss trends in Risk Management Plans (RMPs) and evaluate regional challenges and customization strategies for risk minimization
- Recognize international best practices in the regulation of rare diseases, including potential for evolving frameworks to facilitate access to innovative therapies

Comité del programa

Marta Avellar Medical Information Head, Latin America and North America Medical Information
Takeda, Brazil
Arthur Bueno, PharmD, MBA Country Safety Head Back-Up
Sanofi Brazil, Brazil
Raphael Elmadjian Pareschi, PharmD, MBA Patient Safety Lead/ Head of Pharmacovigilance Brazil
Roche, Brazil
Flavia Firmino Ribeiro, PharmD Director Reg Global CMC
Pfizer, Brazil
Cammilla Horta Gomes, MA, MPharm Latam Regulatory Policy Lead
Roche, Brazil
Susan Koepke, MBA Head of Regulatory Affairs LATAM
EMD Serono, Inc., United States
Lawrence Liberti, PhD, RAC Director, D.K. Kim International Center for Regulatory Science
The Kim Center/ USC DRQS, United States
Mercedes Paloma Lopez, MA Regional Operations Manager, Latin America
WCG Clinical, United States
Elkiane Macedo Rama, MSc Advisor to the International Affairs Office
Brazilian Health Regulatory Agency (ANVISA), Brazil
Viktoria Magyar, LLM, MSc Doctoral Student, Department of Regulatory and Quality Sciences
USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences, United States
Rosana M. Mastellaro, PharmD, RPh Director, Technical Regulatory Affairs and Innovation
Sindusfarma, Brazil
Barbara Nardi, PharmD Global Director - Medical Communications
Thermo Fisher Scientific, Brazil
Patricia Oliveira Pereira Tagliari, LLM, MPH Associate Director of the Second Directorate
ANVISA, Brazil
Lisette Pérez Ojeda Asesora de la Dirección
CECMED, Colombia
Ana Pineda Zavaleta, MSc International Regulatory Analyst, LAO, OGPS, OPLIA, OC
FDA, United States
Duglas Rodriguez Calderon, MSc Global Head of LATAM Regulatory Policy, Global Regulatory Policy & Intelligence
Roche, United States
Maria Antonieta Tony Roman, MPharm Head Regulatory Policy Emerging Markets LATAM
Novartis, Mexico
Diego Alexander Salas, LLM Regulatory Affairs Director
Federación Latinoamericana de la Industria Farmacéutica, A.C., Mexico
Leonardo Semprun, PharmD Global Regulatory Policy Lead-LatAm
MSD, Panama
Ricardo Uribe, MBA Region Head, Clinical Network - Latin America
Fortrea Clinical Development Mexico, S. De R.L. de C.V., Mexico
Gislaine Villarta Capeleti Dib, PharmD Patient Safety Manager
PGA Farma, Brazil
Susan Zavala Coloma, MS, RPh Specialist, Sanitary Evaluation of Pharmaceutical Products, Biological Products
DIGEMID, Peru
Representative Invited DIA, United States