The Drug Information Association (DIA) is a global and neutral association that mobilizes the life science community (regulators, industry, healthcare professionals, patients, payers, and students) to identify and tackle the most complex health challenges. DIA brings all these stakeholders together to find and discuss solutions, build a more robust and innovative healthcare ecosystem and, ultimately, improve patient outcomes worldwide. 
 
DIA executes its mission by fostering timely and critical conversations and networking sessions across many platforms, including conferences, workshops, DIA-led research projects, structured training, eLearning courses, digital content platforms, and publications, without corporate funding. 


This session explores the key elements of the Windsor Framework, offering insights into its implementation and practical implications for QPPVs. Covering topics such as PSMF, PASS, and local RMPs, industry experts share their experiences and engage with the audience to gather feedback on the post-Windsor Framework landscape.

You also gain a comprehensive understanding of early inspection feedback from the MHRA and hear from industry representatives about unexpected challenges encountered during implementation. This interactive session provides a valuable opportunity for discussion, reflection, and knowledge-sharing on the evolving regulatory environment.

[UK QPPV Workshop 2025]

In an era where artificial intelligence and regulatory complexity converge, the role of the QPPV has never been more critical — or more exciting. This QPPV Talks Webinar brings you two thought-provoking presentations exploring the power of AI-based regulatory intelligence tools, the essential collaboration between QPPVs and LCPPVs, and the QPPV’s unique responsibility in ensuring safe, compliant, and ethical AI implementation within PV systems. Discover practical strategies, real-world examples, and actionable takeaways to help you lead with foresight and integrity in a rapidly evolving field. 

QPPV and PV Regulatory Intelligence, New Tools and LCPPV-QPPV Interaction 
- Jose Alberto Ortiz, CEO, PVpharm

From AI Vavavoom to Vigilance: The QPPVs Role in Responsible AI Implementation 
- Natasa Mihajlovic, Managing Partner & Principal PV Consultant, NostraPharma

DIA QPPV Talks Webinar: From Intelligence to Innovation - The QPPV’s Role in AI and Regulatory Vigilance

How has pharmacovigilance evolved to address the complexities of modern therapies? Initially focused on simpler medicines, pharmacovigilance now tackles sophisticated modalities like CAR T-cell and gene therapies. This session explores the benefits of early risk profiling for CAR T-cell therapies and the harmonization of pharmacovigilance guidance for next-generation biologic therapies. The session features a panel discussion with industry and regulatory experts, who discuss the challenges of maintaining an effective pharmacovigilance system capable of handling the complexities of new therapeutic advancements.

[DIA Europe 2025] Innovation in Pharmacovigilance: CAR-T, Gene Therapies and New Modalities

Regulatory Science provides a foundation for evidence-based regulatory innovation. For several years pre-competitive consortia including IMI have employed regulatory science approaches to deliver innovative tools and methodologies to improve efficiency and reduce development timelines for medicine development, while maintaining quality, safety and efficacy standards. As the projects are product agnostic they may be generalisable, and derisk new processes. Applying lessons learned from these past experiences to shape future activities is at the heart of this session.

By examining the current state of play for regulatory science and innovation in Europe, as well as identifying critical questions for the future, this session explores the conditions and opportunities for building a more optimal collaboration infrastructure in Europe. It also highlights best practices, practical experience, and steps towards collaboration in regulatory science research.

Translation of project outputs into regulatory acceptability is often critical for the outputs to be considered by developers in their R&D strategies and to gain the maximum value from the project. At the same time success often relies on intermediaries who were not directly involved in a project and on navigating a complex policy environment, rather than on having direct control over implementation. The session considers the level of regulatory engagement/ acceptance that pre-competitive projects may need, and explores how successful different approaches to engage regulators and other health system stakeholders have been.

[DIA Europe 2025] Multistakeholder Collaboration to Drive Regulatory Science in Europe

The session provides an overview of the ICMRA's Pharmaceutical Quality Knowledge Management project. There is a detailed discussion on the learnings from the ICMRA PQKM pilots on collaborative assessment of post-approval changes and hybrid inspections by multiple authorities. The session also discusses how such pilots can be leveraged with other international collaboration programmes for a positive impact on global supply.

[DIA Europe 2025] Global Partnerships to Accelerate Availability of Quality Medicines

This session explores global efforts to advance diversity, equity and inclusion in clinical trials, focusing on underserved populations and specifically women. Attendees hear perspectives from regulatory authorities, industry and beyond with insights into key guidance, policy recommendations, and actionable steps for change. 

The session features a keynote from EMA, covering its guidances and initiatives to advance clinical trial diversity. The keynote is followed by a panel discussion on what underserved populations we should focus on, implications for not including underserved populations and what different stakeholders are doing to include those populations. 

A second keynote highlights policy recommendations for advancing women’s health in clinical research, followed by a panel discussion on the need to drive innovation in women-specific conditions and the need for the inclusion of women in trials as well as a “call for action” to drive meaningful change. 

Both panel discussions conclude with an interactive Q&A, offering attendees an opportunity to engage directly with the speakers and deepen their understanding of these critical issues.

[DIA Europe 2025] Inclusion of Underserved Populations in Clinical Trials

Discover what fuels Europe’s innovation engine. This session discusses the diverse stakeholders that make up the European innovation ecosystem, including R&D, manufacturers, regulators, payers, and patient representatives. It discusses how efficient R&D and robust supply chains contribute to Europe’s global leadership in technological platforms and innovation. It will also navigate the complex landscape of Europe’s policy pillars and the reforms proposed by the European Commission. Join us as we examine opportunities to strengthen European innovation and address key concerns such as access, affordability, and availability of medicines.

[DIA Europe 2025] The Future of Innovation in the EU – A Europe of Possibilities

Collaboration, trust, and transparency are the key to advance. In this session, various regulatory bodies from the Middle East region will share updates on their regional success stories and best practices to support regulatory system strengthening and achievement of maturity levels. The session will highlight the collaborative efforts and lessons learnt from the interactions with the various healthcare stakeholders, with a focus on current improvements to prepare for the future. In addition, this discussion will build up on the discussions from the DIA MENA Conference, which took place on 26-27 November 2024, in Cairo, Egypt.

[DIA Europe 2025] Middle East Townhall: Collaboration and Future-Proofing the Regulatory Framework

In this session from 2024’s UK National QPPV Forum, experts from both small and large pharmaceutical companies discuss how they are preparing for the practical implementation of the Windsor Framework. The session covers key regulatory considerations and real-world strategies relevant to QPPVs and pharmacovigilance teams.

[UK National QPPV Forum 2024] Practical Implementation Aspects of the Windsor Framework: Small & Big Pharma Insights

Post-Approval Changes (PACs) are an essential part of the lifecycle management of a product to ensure continuous supply of live-saving medicines. However, bringing CMC and labelling changes through global Health Authority systems can be a complex, lengthy process and can take up to several years. Even though Reliance has been widely implemented in the Middle East and North Africa (MENA) regions to accelerate regulatory approvals and enable the early access to new innovative medicines, it is still not widely used for PACs.

This webinar explored opportunities to optimise lifecycle management of medicinal products in the MENA regions by expanding the use of Reliance to PACs, with the overall objective of securing supply to patients. 

This webinar is intended for professionals from regulatory bodies, the pharmaceutical industry and academia who wish to learn more about the optimisation of lifecycle management through the implementation of Reliance for PACs.

Optimising Lifecycle Management in Middle East & North Africa

This 45-minute on-demand webinar provides an exclusive preview of the DIA Global Forum for Qualified Persons for Pharmacovigilance (QPPV). The session features two expert speakers who delve into critical topics in pharmacovigilance.

Ilaria Grisoni, Executive Director, Head of EU/International PV & Global Risk Management and EEA at Gentium Srl (a Jazz Pharmaceuticals Company), discussed strategies for fulfilling global requirements for monitoring and communicating important safety information to regulatory authorities.

Gabrielle Amselem, Director, Pharmacovigilance Excellence Expert at Alexion, AstraZeneca Rare Disease, explored the practical and efficient merging of Pharmacovigilance System Master Files (PSMFs).

Watch this webinar on demand to gain valuable insights from industry leaders and get a glimpse of what this year's QPPV Forum had in store!

DIA QPPV Talks Webinar

Drug repurposing is regarded as a potential solution to treatment gaps and increasing healthcare costs, especially after COVID. However, this complex topic grants deeper discussion and a collaborative, multi-stakeholder approach.

[DIA Europe 2024] Drug Repurposing: Opportunities & Challenges

Is the current pharmacovigilance and patient safety ecosystem sustainable? Using the themes of people, technology and regulations, this collaborative session explores the changes that the community feels need to occur for how we operate to become sustainable.

Led by three members of the community, participants are allocated to one of three themes and guided through an exercise to understand the as-is, ideation of the future state and define the changes. All participants of this interactive session received an output, which can be used as a stimulus for change in their area of Pharmacovigilance and Patient Safety.

[DIA Europe 2024] How to Build a Sustainable Pharmacovigilance Ecosystem?

The EU HTA Regulation will change the HTA decision making landscape in EU and preparation is in full speed by all stakeholders. This session addresses this and other hot topics in the HTA arena. As the EU HTA Joint Clinical Assessment (JCA) will parallel the review process by Regulators, time for preparation of both dossiers, review, decision making and alignment with subsequent national reimbursement processes will provide new challenges for industry, HTA bodies and Regulatory Agencies. Patients and Physicians expect that access in innovation will be facilitated.

This session outlines the challenges from various stakeholder perspectives and provide a vision on how all can best interact during the procedure while keeping the remit of the various assessment bodies.

[DIA Europe 2024] HTA Townhall – Ready for 2025 EU Joint Clinical Assessment

The Global COVID-19 pandemic and climate change have exacerbated the underlying vulnerabilities of health care system and amplified the disparities in health outcomes among diverse populations. Across the globe, healthcare decision makers are making an engagement towards enabling a sustainable, equitable and resilient healthcare system. Sustainability efforts must be integrated across the continuum from trial design to evidence generation to its assessment and appraisal and ultimately at the point of delivery. This panel session features experts who share their insights on key topics.

[DIA Europe 2024] Environment, Equity and Future-Proofing in Healthcare Systems

The ICH has announced upcoming guidance development on patient preference studies. This session brings together different stakeholders to discuss the state of play and recommendations for patient preference studies in the regulatory and health technology decision context. In particular, the session focuses on the role of preference studies in different decisions, methodological challenges and opportunities, and expectations from the patient community for inclusion of preference studies in regulatory submissions.

[DIA Europe 2024] Preference Studies in Regulatory and Payers' Decisions

Building on the DIAmond session on the topic of ‘The New Pharmaceutical Legislation’ - This session deep dives into its impact on Regulatory Operations; highlighting the role of automation and interoperability within regulatory affairs in Europe and how sector hopes to achieve regulatory efficiency from the process, data and technology point of view. The session is also complemented by a case study that deep dives into electronic product information to address what is perceived as missing both from a content and technical point of view.

[DIA Europe 2024] Impact of the New Pharma Legislation on Regulatory Operations

Preparing labelling content for submission and authorisation today is still a very convoluted manual process, which involves lots of transcription and adaptation to meet regulatory requirements. Furthermore, downstream processes such as translations, artwork creation and compendium publishing are equally dependent on manual steps, not to mention the upstream core labelling conformance checking. Obviously, basic MS Word (copy/paste) is still the number one tool in a Regulatory Operations professional’s toolkit and productivity has reached its limits. Cost of poor quality is high, and mitigating risks of labelling mistakes becomes increasingly difficult.

Meanwhile, digital technologies have advanced, and they are ready to transform this space. In this session, we reimagine the labelling end-to-end process thanks to digital technologies, with a focus on the EU centralized procedure, where 96% of marketing authorisations are based on languages other than English. We discuss how modern content and notably translation technologies can support the challenge of managing all EU/EEA languages, with a focus on achieving and maintaining the highest quality and regulatory compliance whilst improving productivity. Industry experience and lessons learnt are also shared.

Learning Objectives:
1) Recognize the typical challenges with regard to end-to-end EU centralised procedure for labelling, from authoring to translation and update cycles;
2) Assess the importance of adopting emerging content and language processing innovations, in order to modernize regulatory practice;
3) Gain insight into the experiences, lessons learnt and key success factors for a sustainable digital transformation - meeting both the regulators’ policy standards for patient safety and company’s (global) objectives. For a Global Pharma organisation, EU CP labelling is just one of the many Global Labelling challenges.

[DIA Europe 2024] Reimagining Labelling E2E Process: EU Centralised Procedure

Complex innovative design trials are revolutionizing clinical research by adopting new and advanced methodologies beyond the standard randomized controlled trial design, resulting in accelerated drug development and improved patient outcomes. In this session, regulators and industry experts discuss the development of master protocol studies, acceptance of the design and data of these trials by key-decision makers, as well as the impact of IMI EU-PEARL’s deliverables.

Complex Innovative Design Trials

Presented by

About this talk

DIA Europe (Drug Information Association)