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DIA Latin America Annual Meeting Call for Topics: Submission Form
Welcome to our 2026 Latin America Annual Meeting Call for Topics brainstorming activity!!
What topic(s) would you like to see at DIA’s Latin America Annual Meeting in 2026? By brainstorming together, we aim to gain a better understanding of your professional needs and the type of content we should focus on for the DIA Latin America Annual Meeting agenda. Please note: submission of a topic suggestion is not related to chairing a session or speaking at the Latin America Annual Meeting.
*Please select the topic(s) you would be interested in hearing about at the meeting (select all that apply). If something is not listed, please add to the “other” field at the bottom:
1.
Regulatory/Clinical Track:
The regulatory/clinical track provides a dynamic platform to explore the evolving regulatory landscape and clinical research practices across Latin America. Participants will engage with case studies, best practices, and emerging trends in life science R&D, with a special focus on integrating medical devices into regulatory and clinical frameworks. This track highlights innovative approaches to compliance, multi-regional cooperation, and practical strategies for the successful development and management of both pharmaceutical products and medical devices.
Regulatory:
Advances in Artificial Intelligence (AI) and Technology
Advanced Therapy Medicinal Products (ATMPs)
Chemistry, Manufacturing and Controls (CMC)
Current Challenges, Opportunities, and Best Practices in Achieving Efficient Regulatory Oversight in the LATAM Region
Digital Health Landscape (e.g., e-Labeling, software as a medical device [SaMD], applicable regulatory frameworks, and other digital solutions)
eCTD and Cloud-Based Submissions
Effect of Emerging Regulations on Global Registration Strategies
Emergency Preparedness
Facilitating Access to Innovation in LATAM (e.g., practical pragmatic approaches)
Good Regulatory Practices
Good Reliance Practices (e.g., optimizing regional reliance initiatives)
ICH Updates (e.g., Data structuring for marketing authorization)
Lifecycle management
Orphan Drugs and Rare Diseases
Regulatory Collaboration and Cooperation Initiatives (e.g., cross-industry collaborations, Project Orbis, Access Consortium)
Regulatory Considerations for Medical Devices and Wearables in the LATAM Region
Regulatory Convergence (e.g., implementation of ICH guidelines, International Medical Device Regulators Forum [IMDRF])
Regulatory Inspections (in-person and virtual)
Regulatory Intelligence and Regulatory Strategy
Regulatory Priorities, Plans, Projects, and Updates from Regional and National Regulatory Authorities
Tools for Strengthening Regulatory Systems in the Americas
Utilization of Real-World Data (RWD) and Real-World Evidence (RWE) for Regulatory Decision Making
Other Topics (Please note - the suggestion may not exceed 300 characters)
2.
Clinical:
Potential Topics:
Chemistry, Manufacturing and Controls (CMC)
Clinical Endpoints (e.g., surrogate endpoints)
Clinical Evaluation and Trial Requirements for Medical Devices
Clinical Trial Data Collection, Management, and Sharing
Clinical Trial Disclosure and Data Transparency
Clinical Trial Submissions and Approvals
Clinical Trial Operational Challenges, Best Practices, and Lessons Learned from Sponsors
Decentralized Clinical Trials (DCTs)
Good Clinical Practice ( e.g., ICH E6 revision)
Good Manufacturing Practices (GMP) and Inspections
Innovation in Clinical Trial Development
Innovative Clinical Trial Design
Life Cycle Management (e.g., post-approval changes)
Multiregional Clinical Trials
Outsourcing Clinical Operations (e.g., hybrid)
Participant Recruitment and Retention Best Practices and Lessons Learned
Patient Engagement and Centricity
Quality and Compliance in Clinical Operations
Representation in Clinical Trials
Statistical Considerations for Clinical Trial Design
Use of AI and Technology in Clinical Trials
Utilization of RWD and RWE in Clinical Trials
Other Topics (Please note - the suggestion may not exceed 300 characters)
3.
Safety and Pharmacovigilance Track:
Dive into the latest advancements in clinical safety and pharmacovigilance for pharmaceutical products and medical devices within the dynamic landscape of Latin America. Our safety and pharmacovigilance track offers attendees a deep dive into essential topics, including best practices, case studies, and regulatory compliance strategies, ensuring a comprehensive understanding of this critical aspect of the life sciences industry.
Potential Topics:
Advanced Techniques in Signal Detection
Advances in Patient Safety (e.g., digital healthcare systems, medication alerts, facilitating information sharing, etc.)
Best Practices for Safety Governance Models
Crisis Management and Preparing for Future Pandemics
Current Challenges, Opportunities, and Best Practices in Strengthening Pharmacovigilance in the LATAM Region
Drug Safety Physicians – Key Activities on the Benefit-risk Safety Profile of Medical Products
Future of Pharmacovigilance
GVP Inspections (in-person and virtual)
ICH Safety Related Updates
Patient Centricity and Safety
Pharmacovigilance for Novel Therapies, such as Advanced Therapies
Pharmacovigilance in the Context of RWD and RWE
Pharmacovigilance Activities Related to Clinical Trials
Post-approval Safety Studies
Post-Market Surveillance of Medical Devices (e.g., class II, class III)
Regulatory Challenges for Pharmacovigilance Operational Processes and Procedures
Risk Management Tools and Techniques
Risk Communication
Safety for Cosmetics/Cosmetovigilance (safety activities and good practices for cosmetics, examples of regulations – FDA, EMA and Latam, tec.)
Technovigilance
Training and Education in Pharmacovigilance
Trends in Safety Surveillance and Benefit-Risk Assessment
Use of Artificial Intelligence (AI), Machine Learning (ML), Automation, and Technology in Pharmacovigilance (e.g., Zero touch case processing, automated causality assessment algorithm)
Vaccines safety activities (PV activities for vaccines and the integrated process with National Immunization Programs – experiences in Latam)
Other Topics (Please note - the suggestion may not exceed 300 characters)
Thank you so much for contributing to our Latin America Annual Meeting brainstorming exercise!
For more information on DIA’s
Latin America Annual Meeting
, visit the meeting website.
