Call for Presentation Abstracts
Read Submission Guidelines| Submit
Abstract Submission Deadline: Wednesday, February 18
Notification: Week of May 8
Final PowerPoint Presentations Due: August 19
Meeting Dates: September 9-11
Location: Mexico City, Mexico
Questions: Contact Lynda.Fisher@DIAglobal.org
Are you a professional involved in the regulatory/clinical and safety and pharmacovigilance functional areas within a company or organization working on pharmaceuticals, medical devices, and/or diagnostics in Latin America? If so, DIA wants to hear from you!
To ensure that we have the most comprehensive and cutting -edge program, we are seeking abstract submissions from professionals like yourself, who are pushing the boundaries in their respective fields. We encourage you to submit abstracts that reflect the l atest trends, innovations, and best practices in regulatory, clinical, and pharmacovigilance in Latin America. We will be accepting the following formats:
- Presentations: 15-20-minute presentation to be bundled with other presentations to create a session (1 author/speaker)
- Sessions: 60-75-minute total session 1 author/speaker + 2 additonal speakers)
- Workshop: 60 -75-minute workshop delivered in an interactive/simulation or role -playing format (1 author/speaker + 2 additional speakers)
- Short Courses: three-hour interactive workshop delivered in a small group format. These will be delivered virtually and require a separate fee from attendees (3 speakers maximum, must all be from different companies)
The Latin America Annual Meeting Program Committee is seeking abstracts on the following topics (keep in mind, business use cases and lessons learned are encouraged in all topic areas). Please note that this meeting is attended by many regulatory professionals, service providers, and health authority representatives, and therefore, topics in addition to those listed below that you feel are relevant may be submitted for evaluation and possible selection.
Regulatory:
- Current Challenges, Opportunities, and Best Practices in Achieving Efficient Regulatory Oversight in the LATAM Region
- Advances in Artificial Intelligence (AI) and Technology
- Good Reliance Practices (e.g., optimizing regional reliance initiatives)
- Facilitating Access to Innovation in LATAM (e.g., practical pragmatic approaches)
- Regulatory Priorities, Plans, Projects, and Updates from Regional and National Regulatory Authorities
- eCTD, Cloud-Based Submissions, and data structuring for marketing authorization
- Advanced Therapy Medicinal Products (ATMPs)
- Effect of Emerging Regulations on Global Registration Strategies
- Orphan Drugs and Rare Diseases
- Good Regulatory Practices
- ICH Updates
- Emergency Preparedness
- Good Manufacturing Practices and Regulatory Inspections (in-person and virtual)
- Regulatory Intelligence and Regulatory Strategy
- Regulatory considerations for Medical Devices and Wearables in the LATAM Region
- Regulatory Collaboration and Cooperation Initiatives (e.g., cross-industry collaborations, regulatory joint initiatives)
- Health Technology Assessments (HTA)
- Utilization of Real-World Data (RWD) and Real-World Evidence (RWE) for Regulatory Decision Making
- Regulatory Convergence (e.g., implementation of ICH guidelines, International Medical Device Regulators Forum [IMDRF])
- Tools for Strengthening Regulatory Systems in the Americas (e.g. WHO Global Benchmarking Tool [GBT], and WHO Listed Authority [WLA] designation)
- Lifecycle management, and Chemistry, Manufacturing and Controls (CMC)
- Digital Health Landscape (e.g., e-Labeling, software as a medical device [SaMD], global IDMP, applicable regulatory frameworks, and other digital solutions)
- Counterfeiting, smuggling, and substandard quality medical products
Clinical:
- Use of AI and Technology in Clinical Trials
- Good Clinical Practice (e.g., ICH E6 (R3) revision)
- Utilization of RWD and RWE in Clinical Trials
- Multiregional Clinical Trials
- Innovative Clinical Trial Designs and Development Approaches Clinical Trials Submissions and Approvals
- Clinical Trial Data Collection, Management, and Sharing
- linical Trial Operational Challenges, Best Practices, and Lessons Learned from Sponsors
- Life Cycle Management (e.g., post -approval changes)
- Clinical Evaluation and Trial Requirements for Medical Devices
- Decentralized Clinical Trials (DCTs)
- Patient Engagement and Centricity
- Clinical Endpoints (e.g., surrogate endpoints)
- Quality and Compliance in Clinical Operations
- Representation in Clinical Trials
- Outsourcing Clinical Operations (e.g., hybrid)
- Clinical Trial Disclosure and Data Transparency
- Participant Recruitment and Retention Best Practices and Lessons Learned
- Statistical Considerations for Clinical Trial Design
- Clinical Research Sites and Trial Execution Excellence
Safety and Pharmacovigilance:
- Current Challenges, Opportunities, and Best Practices in Strengthening Pharmacovigilance in the LATAM Region (regional challenges and current landscape)
- Use of Artificial Intelligence (AI), Machine Learning (ML), Automation, and Technology in Pharmacovigilance (e.g., Zero touch case processing, automated causality assessment algorithm)
- ICH Safety Related Updates
- Risk Management Tools and Techniques
- Training and Education in Pharmacovigilance
- Post-approval Safety Studies and use of RWD and RWE data
- Regulatory Challenges for Pharmacovigilance Operational Processes and Procedures
- Risk Communication and Advances in Patient Safety (e.g., digital healthcare systems (Industries / Health Care Institutions / Academia), medication alerts, facilitating information sharing, etc.)
- Technovigilance
- Best Practices for Safety Governance Models
- Vaccines safety activities (PV activities for vaccines and the integrated process with National Immunization Programs – experiences in Latam)
- Post -Market Surveillance of Medical Devices (e.g., class II, class III)
- Pharmacovigilance for Novel Therapies, such as Advanced Therapies / Pharmacogenomics
- Advanced Techniques in Signal Detection
- GVP Inspections (in -person and virtual)
- Pharmacovigilance Activities Related to Clinical Trials
- Crisis Management and Preparing for Future Pandemics
Selected abstracts will then be added to the program agenda within one of the below tracks!
Regulatory/Clinical Track: The regulatory/clinical track offers a dynamic platform to explore the evolving regulatory landscape and clinical research practices across Latin America. Participants will engage with real-world case studies, best practices, and emerging trends across life science R&D. This track showcases innovative approaches that strengthen regulatory functions and institutional performance, while supporting effective compliance, regional and multi-regional cooperation, and practical strategies for the successful development, approval, and lifecycle management of both pharmaceutical products and medical devices.
Safety and Pharmacovigilance Track: Dive into the latest advancements in clinical safety and pharmacovigilance for harmaceutical products and medical devices within the dynamic landscape of atin America. Our safety and pharmacovigilance track offers attendees a eep dive into essential top ics, including best practices, case studies, andregulatory compliance strategies, ensuring a comprehensive understanding of this critical aspect of the life sciences industry.
Abstract Details and Guidelines
