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

This session will offer a platform for dialogue on the operationalization of AMA and will discuss proposals on improved collaboration in Africa on regulatory harmonisation and convergence, application of reliance pathways and digitalisation.


This session will offer a platform for dialogue on the operationalization of AMA and will discuss proposals on improved collaboration in Africa on regulatory harmonisation and convergence, application of reliance pathways and digitalisation.

[DIA Europe 2024] Africa Townhall

This session will provide stakeholders an in-depth information session on selected ICH guidelines (efficacy, quality and safety) and will give stakeholder the possibility to interact with the experts that have contributed to the harmonisation work.

[DIA Europe 2024] ICH Townhall, part 2

[DIA Europe 2024 ] IVDR (In-Vitro Diagnostics Regulation)

This session will provide a platform for scientific exchange among the EMA, the EC DG Research and other global health authorities (e.g. FDA), patient advocates, and drug development innovators on the evolving global landscape for precision medicine

Precision Medicines: How the Regulatory Framework keeps up with Evolving Science

This session will focus on the regulatory framework for product Life-cycle Management. In particular, the participants will discuss the impact of the new ICH M4Q (R2) and the guidelines developed by the Expert Working Group; the new EU variation guideline and the opportunity for pragmatic approaches to PAC (Post Approval Changes) and the implementation of PAC using ICH Q12 principles, harmonization of regulatory requirements and the use of reliance to enable accelerated implementation of changes globally.

Key stakeholders including regulators, industry and patients are invited to discuss the impact of the current and new regulatory legislation on PACs.

[DIA Europe 2024] Life-Cycle Management and CMC dossier

The session will focus on the impact of the Green Deal initiative as priority of the EU which will have an impact on the healthcare sector, particularly on the continuity of pharma R&D and manufacturing.

The session will bring together those who are engaging in developing relevant EU chemical and environment legislative and non-legislative dossiers (Commission, regulators), and those who will be impacted (industry, suppliers) to discuss three identified case studies and discuss opportunities. This track will provide insights into how manufacturers and regulators can collaborate to deliver this revolution without risks to the supply of medicines. Participants will be invited to share their concerns and ideas to progress innovation and concepts in moving towards a more sustainable future of the healthcare sector.

[DIA Europe 2024] Sustainability and CMC (Chemistry, Manufacturing and Controls)

This session will discuss the evolving global landscape for decentralised clinical trials, to (1) impact of recent and ongoing DCT initiatives and activities by various stakeholders (2) evaluate where we are in fulfilling the promise of DCTs for each stakeholder (3) debate what still needs to be done to advance the use of decentralised elements.

[DIA Europe 2024] Clinical Trials with Decentralised Elements

The session will provide multistakeholder views on ongoing activities happening in the landscape, including the first milestones in Collaborate, as well as highlights from ACT EU programme, including a wider European perspective on development of risk-based approaches.

Learning Objective


The objective of the session is to understand the progress and lessons learned during the first year of experience following full implementation of the EU CTR. It aims to give a voice to regulators, ethics committees, trial sponsors, and patients via presentations and active debate on the advantages of the system and ways to maximizing its potential for the benefit of patients and EU research.

[DIA Europe 2024] Futureproofing of the EU Clinical Trials Regulation (CTR)

[DIA Europe 2024] How RWE Is Transforming Regulatory Decision Making?

This session will focus on the emerging EU AI regulatory and policy landscape / ecosystem and how it relates to medicines development, with a specific focus on the EMA/HMA’s draft reflection paper on AI in medicines. With perspectives from regulators, legislators, patients and industry, we will discuss how these frameworks could impact the development of AI in medicines and explore practical recommendations to foster the development of reliable and responsible AI across medicines lifecycle development.

[DIA Europe 2024]  AI in Medicines Lifecycle

This session will focus on the global regulatory frameworks for enabling innovation in manufacturing and quality. Innovation includes the development and manufacture of new types of products, new manufacturing platforms, innovative technologies such as model-based controls, the wider scope of and new analytical technologies. The discussion comes at a critical time as the implementation of new digital tools and manufacturing technologies are key to the evolution of manufacturing, which can be enabled by tools such platform technology master files, The session will also reflect on how groups such as the new EMA Quality Innovation Group is seeking to lead the transformation of medicines’ manufacturing in Europe and how this is linked to fast moving initiatives outside of Europe, such as FDA FRAME and platform design technology programs, ICH, and ICMRA collaborative initiatives under the PQKMS umbrella, including collaborative assessments. The discussion will also focus on how collaboration and the identification of risk can already enable technology.

[DIA Europe 2024] Global Innovation in Manufacturing and CMC

Dive into the future of regulatory excellence with in this DIAmond session, on "Digital Transformation in the EU Regulatory Space."

This session will focus on the concrete plans that have been made for digital transformation in the regulatory space for the next ten years and gathers Healthcare regulators, European Commission representatives, Patient advocates, Technology disruptors and Industry leaders to explore the critical success factors driving digital evolution. Join us and be part of the conversation that shapes the next era of regulatory dynamics. Don't miss your chance to navigate the transformative journey ahead.

[DIA Europe 2024] Digital Transformation in EU Regulatory Space

The concept of unmet medical need (UMN) plays an important role in investment and priority-setting decisions by a range of stakeholders, including regulators, HTA agencies, payers, academics and the pharmaceutical industry. Identifying a particular condition or disease area as an UMN is intended to signal its health policy significance, stimulate research activities and incentivise the development of innovative treatments, diagnoses or health technologies in these areas. Incentives associated with the identification of an UMN can take the form of preferential access to public research funds, access to alternative or accelerated regulatory pathways, consideration of UMN as a value element in HTA, and financial incentives or innovative payment models in reimbursing the health benefits a new treatment delivers.

As UMN should help to shape policy and action from early phase research, through clinical development to pricing and reimbursement to how a new medicine is used in practice, how the research and healthcare communities define and quantify unmet medical need is challenging as every patient’s perspective is very personal according to their own experience of living with disease and each constituency’s view of unmet need is formed by their own professional expertise and opinion.??

As the European Commission proposed to define the concept of UMN in the current legislative review, the concept is broadly discussed with divergent views. The session will bring together key players in pharmaceutical innovation from developers, health and regulatory authorities, patients to discuss Europe’s ambition for a definition of unmet medical need, what is needed and what are challenges.

[DIA Europe 2024] Driving R&D to Meet Societal Needs

The session will focus on the Accelerating clinical trials in the EU (ACT EU) initiative, which aims to transform clinical trials in the European Union. The keynote speech will outline the European Medicines Regulatory Network’s vision for clinical research in the region, reflecting on the progress towards better, faster and optimised clinical trials and highlighting key milestones under ACT EU. A panel of stakeholder representatives will exchange views on the main challenges and opportunities for improving the clinical trial environment in Europe.

[DIA Europe 2024] ACT EU and the Future of Clinical Research in Europe

The EU landscape of policies and regulations governing medicines research, development and manufacturing becomes increasingly complex. Products become more complex and more often than not consist of components regulated by different policies. But there are also unintended consequences where there is a pre-existing link between, for example, food and pharmaceutical rules, or where such link is created when new rules are set up.

Developers of medicines must keep an eye not only on the legislation and guidance directly governing pharmaceutical products R&D and manufacturing but also on the interplay between other sectorial policies and legislations driven by considerations specific to food, device, diagnostics, chemicals, environment, data, etc. As a result, these other policies and regulations can either add to the evidence requirements increasing complexity and cost, or even contradict in some instances the principles on which medicines quality, safety and efficacy rely.

The session will bring together medicine developers, policymakers, national and European regulators from different domains, patients and academics to shed light on examples of such complexities, their impact, pragmatic mitigation measures and general principles that should drive policy development to avoid that complexity turns into complications that prevent R&D or manufacturing in Europe.

[DIA Europe 2024] Complexity: Interplay and Interface of Different Legislations

In this Session, the DIA team and the DIA Europe Programme Committee will go through the main outcomes from each Track, conclusions and identified next steps. Join us to gather fruitful outcomes and a general overview of the most important outcomes from DIA Europe 2024!

DIA Europe 2024 - Closing Session

The EU HTA Regulation will change the HTA decision making landscape in EU and preparation is in full speed by all stakeholders. This session will address 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 will outline 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. As an outcome we expect recommendations - what gaps still need to be closed on our way to full implementation. Several implementing acts are still in drafting stage.

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

Unmet medical need (UMN) is a provision in the pharmaceutical legislation for human medicines, but experience has shown that it can be difficult to apply (read more in the linked article below). In this session, the speakers presented the current perspectives of UMN, discussed new proposals for a definition that have emerged from the proposal for the revision of the pharmaceutical legislation, and debated options and challenges for their application.

DIA Europe  Defining Unmet Medicinal Need & Implications for Regulatory Strategy

The session’s objective was to underscore the urgency of environmental change in healthcare. 
In this session, we explored recent European policies and regulations that propel sustainability and examined the healthcare industry’s audacious measures to reduce carbon emissions in drug manufacturing, mitigate the environmental impact of clinical trials, and establish benchmarks for their initiatives. 
The session concluded with a dynamic discussion on simple steps we can all take to shrink our environmental footprint.

[DIA Europe 2024] Sustainability - A Call to Action!

This session looks back at the effects the new ways of working have had on the Digital Regulatory Business Transformation in Europe and its impact on stakeholders´ resources and planning.

[DIA Europe 2023] Digital Transformation in Europe

The recent implementation of the MDR in Europe, specifically Article 117 for drug-device combination products, still presents challenges for manufacturers, Notified Bodies, and EMA, as additional clarity is needed related to submission content and the review process of significant changes requiring a Notified Body Opinion. This could be further impacted by the upcoming revision of the EU Pharmaceutical Legislation, which may include new approaches to combination product regulation in the EU. This session describes current challenges, proposed criteria for determining significant changes, and calls for additional clarity and proposed solutions on these issues, including upcoming guidance on this topic.

[DIA Europe 2023] Implementing Significant Changes To DDC Products Under EU MDR

In continuation of the dialogue at previous DIA Europe conferences, this session provides an opportunity for further reflections on lessons learned from the response to the COVID-19 pandemic. The success achieved in the CMC development, manufacture, authorization and supply of new therapies and vaccines for COVID-19 in very rapid timescales provides a rich set of experiences. It built significantly on the outcomes from the collaborative work between industry and regulators in recent years, on the role of prior knowledge and innovative science and risk-based CMC strategies to the development of new, high-quality products for unmet medical needs. The challenges for rapid development & commercialization, as well as various approaches to facilitate accelerated development and global supply post initial authorization, will be revisited from a “post-pandemic” point of view. This will include the role of dialogue between sponsors and agencies to facilitate early decision-making and alignment, the value of improving reliance/collaborative assessments and increased collaboration between regulatory authorities (e.g. at the level of ICMRA) to reduce differences in global regulatory requirements and ultimately achieve earlier and greater access to high-quality critical medicines for patients worldwide.

Objective: Learn how to navigate the Quality aspects of accelerated pathway/reliance & work-sharing initiatives and manage the “flood” of post-approval changes (PACs) appropriately. The session covers the entire lifecycle.

[DIA Europe 2023] Enabling Early Patient Access Through Innovation in CMC

Watch this exciting discussion on the field of Dynamic Regulatory Assessment (DRA) and witness this significant multi-stakeholder engagement in a pivotal year 2023 with new legislation under the Pharmaceutical Strategy.

[DIA Europe 2023] DRA – A Key Initiative to Future Proof EU Regulatory Ecosystem

In 2023, the European Commission unveiled a new legal proposal on EU Pharma Legislation, Orphan and Paediatric Regulation. Watch this captivating session to assess proposed "horizontal measures" in the new framework and see what the audiences' thoughts about their potential were to support innovation and enhance the EU's regulatory framework competitiveness.

[DIA Europe 2023] Will the EU Pharma Legislation Deliver Innovation to Patients?

This HTAi-DIA session presents and discusses guidance and an accompanying tool that may facilitate the identification, communication and mitigation of uncertainty in HTA and regulatory decision-making by global, collaborative stakeholder engagement.

[DIA Europe 2023] Uncertainty Management in Regulatory and HTA Decision-Making

The developing data landscape is changing both the way medicines are being developed and their continuous assessment. Real-world data/evidence (RWD/RWE) can bring value to every stage of a drug’s life cycle.This session provides an overview of how RWE has been used by regulatory and HTA agencies at pre and post approval stages; explores through case studies how RWD/RWE has or could be used in the review and reimbursement for rare diseases/early access medicines; discusses the use of RWD as part of integrated evidence generation plans by companies through lifecycle of medicines;, as well as the challenges that companies and agencies face in ensuring that RWD/RWE is fit for purpose.

[DIA Europe 2023] Use of RWE/RWD in Regulatory and HTA For Early Access Medicine

Safe use of medicines is a key objective of pharmacovigilance. However, risk minimisation measures (RMM) have shown to have some limitations in effectiveness. It is hence suggested to study and implement enablers for knowledge and behaviour adoption for risk minimisation in healthcare. Potential enablers may emerge from engagement of patients and healthcare professionals to inform tools and designs of RMM, or from digital health transformation.

Regarding engagement, the Pharmacovigilance Risk Assessment Committee (PRAC) at EMA created in 2022 an innovative pilot forum for analysing options for additional RMM together with PRAC members representing patients and healthcare professionals, called the PRAC Risk Minimisation Stakeholder Alliance (PRISMA). This aims at adding knowledge on healthcare systems and processes, as well as informal input to PRAC for their decisions on additional RMM, with a specific focus on their implementability. Also, regarding potential digital support for RMM, EMA has established a multistakeholder drafting group for developing a reflection paper on opportunities and challenges.

Likewise, pharmaceutical industry has worked together to provide an overview of the existing experience with digital tools including the perspective from a multi-source/off-patent environment, in order to describe a more effective communication of additional RMM and propose solutions that embrace the advantages of digital health transformation.

The potential of above initiatives and the impact on RMM tool selection and design are discussed in this session with a wider multistakeholder audience.

[DIA Europe 2023] Enablers & Behaviour Adoption For Risk Minimisation

This session covers what the future looks like for pharmacovigilance and whether or not we need to make bold and innovative changes to the established approaches from a scientific, technological and regulatory standpoint in order to better protect patients. Are we having enough impact on healthcare systems? Are we focusing on micro level adjustments when we should be looking for a paradigm shift? Are we using the right technology to enable better and more efficient access to safety information? If we were to start with a blank sheet of paper what would a global pharmacovigilance ecosystem look like? During this session, you hear far-reaching discussions from pharmacovigilance thought leaders who challenge the status quo and leave us thinking differently about the future of pharmacovigilance.

[DIA Europe 2023] What is the next Paradigm for Pharmacovigilance?

This session discusses the many different initiatives on Decentralised Clinical Trials (DCTs) ongoing globally and analyses their unique objectives and perspectives, and how they interconnect and collectively move towards same aim of advancing DCTs to bring benefits to patients.

[DIA Europe 2023] An Evolving Global Landscape: Shaping the Future of DCTs

As a non technical stakeholder, ever felt giddy with the Artificial Intelligence and Machine Learning domain, lingo, terminology, applications etc.? This session provides an overview of "must knows" using everyday human language, examples, as well as provide hands on use case examples for lesson learnt discussions. This session will broadly outline various AI and Machine Learning approaches, and importantly as a business stakeholder, what are the touch points, and what a project “looks like” (that is how an AI project should be managed). It also has a short hands on session, using Deep Learning as a method to highlight what a data pipeline can look like, and “do’s and don’ts”.

Workshop Outline:
• Intro to AL and ML – why? What is the value?
• AL and ML fundamentals, what non technical stakeholders should know. Reframing AI and ML in everyday human language.
• What is Deep Leaning? A non technical stakeholder “need to know” overview.
• Use Cases
• What’s involved in an ML project, touchpoints for non-technical stakeholders.
• What can go wrong in a ML project, typical problems
Live example using real data
• Q&A and discussion

[DIA Europe 2023] Demystifying AI and ML For Non-technical Stakeholders

All you Need to Know About HTAR

With the regulation on Health Technology Assessment (HTAR) entering into force in January 2022 and becoming applicable in January 2025, the next two years will be critical for preparing for its implementation. National Authorities and other Stakeholders are preparing to adapt to a new system that has the potential to improve the availability of health technologiesfor EU patients.

In this free webinar, speakers from the European Commission, EUnetHTA 21, among others, will walk you through the critical steps of the HTA process and help you understand the basics of the EU HTA Regulation and its implications.

Essentials on Health Technology Assessment (HTA) and the EU Regulation (HTAR)

Integrating patient voice in medicine development and decision-making has introduced more quantitative approaches to generating patient input and evidence. IMI PREFER has been instrumental in developing the approach to gathering patient preferences, and work has been ongoing globally to develop more patient-relevant clinical outcomes. FDA and ICH work on patient-focused medicines development, and more guidance is expected in the coming years.  

Even if it is acknowledged that patients are central to development programs and regulatory decision-making, there remain challenges to implementing the systematic evidence generation and subsequent use of this evidence in benefit-risk assessment, as well as securing patient involvement as early as possible for this purpose.  

During our DIA Europe's last edition, we brought together patients, regulators, and researchers from public and private sectors to discuss lessons learned from the specific example of interactions on patient-generated evidence, practical solutions found and how these can help progressing patient engagement in other parts of the R&D and medicines evaluation processes:  

Challenges encountered by Industry when developing the evidence and interacting with the regulators to engage with patients and include patient preferences and patient-centric outcomes in the product information. 

The Regulators’ perspective on progress and experience using patient evidence for benefit-risk decision-making.  

The Patient perspective on the issues, proposed solutions, and their impact on patient groups.

[DIA Europe 22] Early Patient Engagement in Drug Development & Decision Making

DIA Europe 2023: On-demand Content

This session highlighted practical experiences by regulators from around the world and industry, leveraging case studies showing different collaborative and reliance pathways and discussing critical factors to identify effective reliance models that enable efficient use of resources and faster access to medicines.

[DIA Europe 2023] - International Collaboration: Reliance in Action

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About this talk

DIA Europe (Drug Information Association)