Roche is a global pioneer in pharmaceuticals and diagnostics committed to advancing scientific discoveries to enhance human health. Originating in Basel, Switzerland in 1896, the Roche Group has grown into a multinational corporation active in over 100 countries. Roches' core business revolves around developing and delivering innovative medicines and diagnostic tools. They are also increasingly focused on leveraging data-driven medical insights to facilitate personalized healthcare. Roche collaborates with partners across the healthcare spectrum with the ultimate goal of providing the best possible care for each individual.
For more information, please visit www.roche.com
Med Communications, Inc. has been a trusted resource for Global Medical Affairs & Pharmacovigilance services throughout its over 26-year history. Med Communications specializes in providing flexible, resourceful services designed to support a range of medical affairs department activities on a global scale. The four main services provided are pharmacovigilance, medical information contact center, scientific communications & medical/promotional review, and regulatory writing services. Over the last 26 years, Med Communications, Inc. has grown significantly and has evolved into a leading provider of outsourced pharmacovigilance services.
Website: https://medcommunications.com/
AB Cube is a trusted leader in global vigilance technology, delivering SafetyEasy® Suite, an all‑in‑one cloud platform designed to make pharmacovigilance, device vigilance, and other vigilance activities simple, scalable, and smart. Built for organizations of every size—from emerging biotechs to global pharmaceutical companies and health authorities—SafetyEasy® Suite streamlines end‑to‑end safety management with automated data capture, compliant workflows, and flexible configuration options tailored to each team’s needs.
With 20 years of expertise, AB Cube provides transparent, compliant, and user‑friendly solutions backed by a robust, pre‑validated framework aligned with international standards. The platform empowers safety teams with seamless global reporting, intuitive dashboards, and full control over workflows—all while offering unlimited users, all‑inclusive support, and scalable pricing. AB Cube’s mission is clear: to power vigilance and fuel innovation, helping life sciences organizations enhance efficiency, strengthen compliance, and ensure patient safety with confidence.
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time.
SteinCares is a leader in commercializing and distributing specialty healthcare products in Latin America, including innovative pharmaceuticals, biosimilars and complex generics. With over 40 years of progressive experience in healthcare and a presence in over 30 countries across Latin America and the Caribbean, we serve as a bridge between the world’s pharmaceutical companies and the region’s healthcare providers.
Our purpose us to create healthcare opportunities that positively impact the lives of patients and their families; our vision, to give more Latin Americans greater access to cost-effective pharmaceuticals that improve their health and lives.
About Nextrove
Nextrove leads the industry in Life Sciences Professional Services and Solutions. Our unwavering mission, “Empowering Clients to Improve Patient Safety,” propels us on the path to realizing our vision of becoming the first choice for Life Sciences professional services and solutions, in service of our clients, partners, and, above all, the patients we ultimately serve.
We are solely dedicated to providing solutions for Pharmaceutical, Biotech, and Contract Research Organizations. As a niche consulting firm assisting clients with Pharmacovigilance, Hosting, Artificial Intelligence Solutions, eTMF, RIM, Regulatory Affairs, Clinical Operations, Medical Information, Salesforce, and Integration Services, we take pride in our unique position in the industry.
Our Progressive Suite of solutions significantly alleviates the most critical challenges in pharmacovigilance operations, with a wide range of products already in active use across numerous Pharmaceutical, Biotech, and Contract Research Organizations.
The convergence of our business proficiency and technical expertise enables us to bridge the gap between business needs and technology, exceeding the expectations of our clients. Clients unequivocally choose us because our values align with theirs: integrity, expertise, client focus, and collaboration.
With over two decades of experience, we have guided clients in adapting to the evolving regulatory landscape. Our business experts have occupied leadership roles in pharmaceutical, biotechnology, and Contract Research Organizations, while our technology leaders have spearheaded efforts in implementing safety systems.
Additionally, our readily deployable frameworks and accelerators ensure swift and efficient project delivery.
Headquartered in Princeton, New Jersey, United States, and with established offices in the UK (Leicester), Italy (Milan), Japan (Tokyo), China (Shanghai), South Korea (Seoul), and India (Noida, Bengaluru, and Mysuru), Nextrove draws from over 20 years of experience to aid our clients in meeting their global digitalization strategy, maintaining regulatory compliance, and significantly reducing the total cost of ownership across various engagements.
Website: https://nextrove.com/
UMC boilerplate
The boilerplate is the standard, approved description of Uppsala Monitoring Centre. Where possible, use the full boilerplate; however, a shorter version is provided for situations with constrained character limits.
Uppsala Monitoring Centre (UMC) is an independent, self-funded, non-profit foundation established in 1978 dedicated to safer use of medicines and vaccines. Through an agreement between the Government of Sweden and the World Health Organization (WHO), UMC operates the WHO Programme for International Drug Monitoring, supporting over 180 member countries and regions in strengthening safety surveillance, and maintains VigiBase, the WHO global database of adverse event reports. In addition, UMC provides international standards and related digital solutions for secure exchange of pharmacovigilance data, including a global medicine and vaccine terminology for identification of medicinal products. With around 200 staff, UMC advances the science of pharmacovigilance and transforms its practice through technological innovation.
About MedDRA:
The MedDRA MSSO (Medical Dictionary for Regulatory Activities Maintenance and Support Services Organization) is the body responsible for maintaining, distributing, and supporting MedDRA, an international medical terminology used globally in drug development and health product safety monitoring. Overseen by the International Council for Harmonisation (ICH), the MSSO manages updates, provides user support (including training and help desks), and ensures MedDRA remains a standardized, clinically relevant tool for regulators and industry.
Links: http://www.meddra.org
LinkedIn: https://www.linkedin.com/
Facebook: https://www.facebook.com/
With 50 years of experience and a presence in 18 countries, Adium has established itself as a leading pharmaceutical company in Latin America. Our purpose is to expand access to innovative treatments that improve quality of life. Through strong strategic partnerships, we license products from more than a dozen global innovation-driven companies, enabling us to offer cutting-edge therapies and treatments for some of the world’s most challenging diseases. We employ more than 7,300 people and operate manufacturing facilities in Argentina, Brazil, Mexico, Paraguay, and Uruguay. Through these capabilities, we help broaden access to healthcare and improve the lives of millions of people across the region.
For more information, visit [adiumpharma.com](https://
Join Deloitte at the 25th ISoP Global Meeting September 22–25 in Costa Rica. Deloitte's dedicated lounge is a good place to recharge and learn about safety solutions like ElevateSafety™ and Detective.
Attend Deloitte’s speaking sessions
Artificial intelligence in PV: Practical implementations and operational reality
Date/Time: Wednesday, September 23, 10:45–11:30 a.m. CST
Speakers: Niklas Norén (UMC, Sweden), Monica Munox (FDA, US), Amanda Bowles (Deloitte Consulting, US), and Lucas Philips (MHRA, UK)
Location: Main stage
Agentic AI for end-to-end pharmacovigilance case intake: A phased implementation
Date/Time: Friday, September 25, 9:20–9:40 a.m. CST
Speaker: Amanda Bowles (Deloitte Consulting, US)
Location: Room C
Relax and recharge in the Deloitte lounge
Visit the Deloitte lounge to unwind and learn more about pharmacovigilance solutions like:
Please see www.deloitte.com/about to learn more about our global network of member firms.
FIFARMA (Latin American Federation of the Research-Based Pharmaceutical Industry) is a regional organization representing the research-based pharmaceutical industry across Latin America and the Caribbean. Through its member associations and companies, FIFARMA works to promote public policies and health systems that foster innovation, strengthen regulatory systems, and contribute to timely and sustainable access to safe, effective, and high-quality medicines.
Since its establishment in 1962, FIFARMA has promoted dialogue and collaboration among the pharmaceutical industry, regulatory authorities, international organizations, academia, and other stakeholders to address shared health challenges across the region.
Regulatory strengthening and pharmacovigilance are central to FIFARMA’s work. The Federation supports regional cooperation, regulatory convergence, Good Regulatory Practices, reliance, and stronger pharmacovigilance systems, recognizing that effective regulatory systems and robust safety surveillance are essential to protecting patients and improving public health outcomes.
FIFARMA is committed to advancing collaboration, knowledge sharing, and capacity building across Latin America, contributing to regulatory and pharmacovigilance ecosystems that are increasingly connected, efficient, and prepared to respond to scientific and technological innovation.
For more information, please visit www.fifarma.org