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 short course covers clinical trial fundamentals from ethical standards to regulatory frameworks such as ICH and Good Clinical Practice. It also touches upon roles and responsibilities, safety reporting and regulatory inspections.

DIA - Navigating Clinical Trials

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

In this inspiring QPPV Talks, Jose Alberto Ayala Ortiz from PVpharm presented how to enhance QPPV oversight through AI integration. 
 
Discover how QPPVs can benefit from AI's power to proactively monitor safety concerns, detect ADRs, and make data-driven decisions effectively. You will also explore crucial considerations such as data quality, algorithm transparency, and ethics in AI integration.

Ready for more QPPV Talks? Then join us at the DIA Global QPPV Forum in Amsterdam on the 8th and 9th of November. Explore topics like inspections, international PV, oversight and much more! 

Learn more about DIA Global QPPV Forum Here: https://bit.ly/43g1Y3U

Enhancing QPPV Oversight of PV Systems through AI Integration

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

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

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

The CTR has been into full application since January 2022. In January 2023, all new EU Clinical Trials need to be submitted under the new CTR unto the CTIS. This session consists of an "interim break": where are we? What have been the experiences with the CTIS and CTR after 1 year of its application, from different stakeholders: from sponsors to regulators and national competent authorities?

CTIS/CTR: 1 Year Into its full Application

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

EU Clinical Trial Regulation: Balancing Requirements Related To Transparency And To Protection Of Personal Private Data And Commercially Confidential Data
The session aims to cover an overview of the different requirements on transparency, the data protection regulation for personal private data, and the set-up for how commercially confidential data might be protected. The focus will be on the strategic view of achieving transparency and the utility of data in CTIS while ensuring EU remains attractive for clinical trials by ensuring sponsors commercially confidential information is protected.

EU Clinical Trial Regulation

This session explore the recent issues surrounding shortages of medicines in the UK. It focus on the role of the QPPV and what is
expected of them in these situations. Discussions include strategies for addressing potential shortages, as well as the importance of communication and collaboration between stakeholders.
Overall, this session provides valuable insights and practical solutions shared by industry and regulators as well as clarify the expectations from the MHRA, including the role of the QPPV in this matter.

MANAGEMENT OF SHORTAGES AND THE QPPV INVOLVEMENT

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