- EDITORIAL
- DIA Reaffirms Commitment to Global Collaboration that Improves Patient Outcomes and Public Health
- FEATURE ARTICLES
- AI-Powered Translation: Use Cases Transform Global Communication in Life Sciences
- Navigating US Regulations for Dispensing Investigational Drugs in Decentralized Clinical Trials
- Data Standards Fatigue?
- COMMENTARY
- Invitation to Comment: Warp-Speeding Regulatory Decisions
- Why Do Sponsors and CROs Need a Trade Association Dedicated to Multisite Research Corporations?
- MEETING HIGHLIGHTS
- DIA India Annual Meeting 2024
Cosmetovigilance: Safeguarding Consumer Health in the Global Beauty Market - DIA Latin America Annual Meeting 2024
Regulatory Systems, Trends, and Innovations in Latin America and the CaribbeanThe Future of Medical Product Development and Approval - AROUND THE GLOBE
- Sustainable Healthcare: Balancing Patient Care and Environmental Impact
- Navigating the Digital Age: A Global Pharmaceutical Company’s Journey in eLabeling
- Accession to the EU: How Can the EMA Pre-Accession Assistance Program Help?
- Cannabis-Derived Drugs in Japan: New Legislation and Outlook
Podcast: DIA/Tufts CSDD Research: AI Saving Time in Drug Development
- WHITE PAPERS
- Docuvera: AI + Structured Content: A new era of pharmaceutical documentation
- Glemser: Next-Gen Clinical Labeling: Streamlining Authoring & Management Workflows with Structured Content AI
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Editorial Board
Content stream editors
Gary Kelloff US National Institutes of Health
Ilan Kirsch Adaptive Biotechnologies Corp.
regulatory science
Isaac Rodriguez-Chavez 4Biosolutions Consulting
Patient engagement
Natasha Ratcliffe Patient Engagement Specialist
Thomas Smith Independent Patient Consultant
Data and Digital
Lisa Barbadora Barbadora Ink
VALUE AND ACCESS
Wyatt Gotbetter Cytel, Inc.
Editorial Staff
Sandra Blumenrath, Senior Scientific Project Manager & Executive Editor, Scientific Publications DIA Scientific Communications
Chris M. Slawecki, Managing Editor, Global Forum DIA Scientific Communications
Linda Felaco, Copy Editor and Proofreader
Regional Editors
David Mukanga Bill and Melinda Gates Foundation
ASEAN
Jin Shun Belief BioMed
AUSTRALIA/NEW ZEALAND
Richard Day University of New South Wales, Medicine, St. Vincent’s Hospital
CHINA
Ling Su Shenyang Pharmaceutical University, Lilly Asia Ventures
EUROPE
Emma Du Four Independent R&D/Regulatory Policy Professional
EUROPE
Isabelle Stoeckert Independent Regulatory Science Expert
INDIA
J. Vijay Venkatraman Oviya MedSafe
JAPAN
Toshiyoshi Tominaga Keio University Hospital, Clinical and Translational Research Center
LATIN AMERICA
Cammilla Gomes Roche
US
Ebony Dashiell-Aje BioMarin
DIA Membership
Bringing together stakeholders for the betterment of global health care.
Global Chief Executive
DIA (Drug Information Association)

t DIA, we believe global collaboration is essential for advancing biomedical science and derisking medical product development by promoting innovation and providing a forum for multistakeholder discussions. Now more than ever, the world faces complex health challenges that require a united effort across nations, organizations, and disciplines.
Genmab
n the fast-paced world of biotechnology and pharmaceuticals, innovation knows no borders. Research collaborations, clinical trials, and regulatory submissions span continents, connecting teams and processes in ways that were unimaginable decades ago. But with these opportunities come new challenges—particularly in communication.
RxE2
ecentralized clinical trials (DCTs) are transforming clinical research by enhancing accessibility and convenience for participants. By reducing the need for travel to traditional trial sites, enabling remote monitoring, and facilitating home-based interventions, DCTs are increasing participation rates and improving diversity in trial populations. The incorporation of local pharmacies into the DCT model further expands these benefits, particularly for underserved communities, creating opportunities for community pharmacists to engage in clinical trials. These roles include recruiting patients, serving as local clinical support sites, and, most importantly, dispensing investigational medicinal products (IMPs). This is new and different than the role played by hospital pharmacists who dispense IMP in centralized clinical trials (CCTs). But it is also important to remember that these roles are subject to regulatory requirements.
AyusArogya Ltd.
DIA AI in Healthcare Community Co-Chair
VB Insights, LLC
DIA RIM Working Group
he pharmaceutical industry has been experiencing a paradigm shift in recent years with the increasing importance of data-centric submissions and new guidance around AI and digital transformations. This, in turn, has increased the importance of data standards, which hold the promise of improving data quality, interoperability, and regulatory compliance. However, given the accelerating intent to adopt and keep pace with rapid evolution in technology, this transition has introduced “Data Standards Fatigue,” the overwhelming feeling experienced by organizations and individuals when faced with the continuous introduction and evolution of data standards from standards organizations and regulatory bodies.
White Paper
White Paper
AI and structured content are transforming how organizations manage pharmaceutical documentation. Together, they create a powerful solution that enhances compliance, efficiency, and adaptability in global markets. In this whitepaper, you’ll discover how:
- AI accelerates documentation with automation, ensuring speed, accuracy, and multilingual accessibility.
- Structured content provides governance, traceability, and reuse for regulatory compliance.
- Together, they streamline processes, reducing manual effort and improving efficiency.
Future-proof your documentation strategy. Download the whitepaper today!
Warp-Speeding Regulatory Decisions
Lilly
Accumulus Synergy
Ipsen
Moderna
Gilead
Novo Nordisk
One2Treat
West Monroe
20/20 Onsite
LeapAhead Solutions
Roche
ata transparency, more collaboration, and technology will lead to faster, more thorough, data-driven decisions and speed up medicine development.
Association of Multisite Research Corporations
he clinical trial ecosystem has become increasingly complex, with the number of drugs in development nearly doubling between 2012 and 2022. This growth, coupled with rising patient recruitment demands and the need for diverse trial endpoints, has highlighted the limitations of the traditional site model.
Accenture, India
Emmes, India
Galderma India Pvt Limited, India
he cosmetics industry has seen unprecedented growth over recent decades, bringing a flood of new cosmetic products and ingredients to the market. With this rise, today’s consumers have access to a vast range of cosmetic options tailored to every beauty goal, from skincare and anti-aging products to hair care and fragrances. Advances in technology and formulation have enabled the development of highly specialized treatments, with innovations such as personalized skincare regimens and smart beauty devices becoming more accessible. The influence of social media and celebrity endorsements has further fueled this boom, creating a culture where beauty products are more than just personal care items—they have become status symbols and lifestyle statements. However, as the industry expands, safety concerns also escalate.
The Future of Medical Product Development and Approval
Drug Information Association (DIA)
Roche, Brazil
The Kim Center/USC DRQS
USC Alfred E. Mann School of Pharmacy & Pharmaceutical Sciences
Thermo Fisher Scientific, Brazil
Novartis, Mexico
n the dynamic landscape of global regulatory practices, Latin America (LATAM, including the Caribbean) is embarking on transformative initiatives to strengthen its international standing as a large global region and align with the World Health Organization’s (WHO) Global Benchmarking Tools (GBT) for evaluation of national regulatory systems.
White Paper
White Paper
Accurate clinical labels are crucial to the pharmaceutical industry because they directly impact patient safety, regulatory compliance, and clinical trial integrity. The current systems that most companies use typically slow down the overall labeling process, require integration with other systems, and create unnecessary challenges. Thankfully, AI-powered structured content tools and platforms are helping companies transform their internal processes around authoring, collaboration, management, artwork, and submission.
Sustainable Healthcare Coalition
Drug Information Association (DIA)
ustainable healthcare provides high-quality care in the present without compromising the health of future generations and our planet. The healthcare sector must play a critical role in delivering sustainable healthcare and achieving this balance for the following reasons: healthcare is itself a significant contributor to greenhouse gas emissions; we must address the risk that climate change presents to the operations of healthcare as an industry; and we must consider the impact of climate change on population health, which in itself places further demand on already stretched healthcare systems. Mitigating climate change through making healthcare more sustainable is imperative. It offers numerous co-benefits: Not only is it good for patients and their health, but it is also a business derisking activity.
A Global Pharmaceutical Company’s Journey in eLabeling
Novartis (Singapore) Pte Ltd.
Novartis Asia Pacific Pharmaceuticals Pte Ltd.
Novartis Farmacéutica S.A. de C.V.
lectronic labeling (eLabeling) generally refers to the distribution of the approved product information of medicinal products via electronic means. This in turn allows prompt communication of current safety information to patients and healthcare professionals (HCPs). If local regulations allow the removal of hardcopy leaflets (HCL), eLabeling can also reduce paper consumption.
European Medicines Agency
Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina
Kosovo Medicines Agency
Institute for Medicines and Medical Devices of Montenegro
Food and Veterinary Agency of North Macedonia
Agency of Medicines and Medical Devices of North Macedonia
Medicines and Medical Devices Agency of Serbia
or any country to become a member of the European Union, a clear set of steps and rules has been established. Such a transition is complex and consists of different stages: the European Council grants countries potential candidate, candidate, or accession status, depending on the status of negotiations. Nine states are currently recognized as candidates for membership in the European Union: Albania, Bosnia and Herzegovina, Georgia, Moldova, Montenegro, North Macedonia, Serbia, Türkiye, and Ukraine. Kosovo formally submitted its application for membership in 2022 and is considered a potential candidate by the European Union.
Keio University
n December 12, 2024, Japan enacted its amended Cannabis Control Law (CCL) and Narcotics and Psychotropic Substances Control Law (NPSCL). The new regulations opened the possibility of cannabis-derived drugs in Japan, especially those containing cannabidiol (CBD).
Around the Globe: US

