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. 


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. The discussion will be followed at the DIA MENA Conference, taking place on the 26th and 27th November 2024 in Cairo, Egypt.

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 present the COMBINE project on the interface between the EU regulations on clinical trials, in vitro diagnostics and medical devices. Combined studies can be understood as studies that involve the simultaneous investigation of a medicinal product, an IVD and/or medical device. The COMBINE project aims to analyse the root causes of the challenges encountered by sponsors in conducting combined studies and to identify possible solutions to these challenges. The project involves representatives of competent authorities, the European Commission, medical research ethics committees, the European Medicines Agency, and relevant stakeholders from both the medicinal product and the medical device sectors. This is a first of kind collaboration across the clinical trials and medical devices sectors looking into the challenges faced by sponsors and authorities in the assessment and authorisation of combined studies.

[DIA Europe 2024] Medical Devices in Clinical Trials

Bringing innovative combination products to the European market is challenging due to divergent/opposing legislation. Innovation is being continuously challenged by a fragmented regulatory system that does not appropriately support the development of products (e.g. convergent technologies) that cut across legislative frameworks.

Even though the European Commission, European Medicines Agency, and Head of Medicines Agencies are working to close the gaps and improve the regulatory system, there is an underlying structural challenge which limits innovation and improvement for about a quarter of all treatments under development for European patients.

All presenters will shortly via two slides and 4 minutes present their perspective and experience on EU combination product regulation, followed by a discussion of the key challenges faced by both industry and regulators.

[DIA Europe 2024] EU Combination Products – Opportunities and Challenges

The session will bring together regulators from different parts of the world, EMA and industry experts will reflect on the current implementation status of reliance pathways. While it is broadly acknowledged that reliance is at the core of a more efficient use of global resources, there are still many challenges?delaying or preventing its broader use. Based on recent data collected by CIRS, concrete example and?surveys from industry we will discuss ?ongoing efforts to bring reliance into action and present different reliance tools currently used by regulators from different jurisdictions with the goal to streamline approvals and ultimately access to patients.? At the same time we will address other critical topics like product sameness and diverging country specific requirements which are crucial when applying reliance and moving towards one global regulatory standard.

[DIA Europe 2024] Thrive through Reliance Implementation

In the midst of global challenges and the implementation of regulatory frameworks, collaboration is the key to advance. Different regulatory bodies from the region will share updates related to their regional success stories and future plans, in addition to the benefits and lessons learnt from the interactions with the various international and regional healthcare stakeholders to support regulatory system strengthening.

[DIA Europe 2024] Middle East Townhall

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

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

[DIA Europe 2024] Clinical Trials with Decentralised Elements

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

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

[DIA Europe 2024]  AI in Medicines Lifecycle

[DIA Europe 2024] Global Innovation in Manufacturing and CMC

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

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

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

DIA Europe 2024 - Closing Session

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

DIA Europe  Defining Unmet Medicinal Need & Implications for Regulatory Strategy

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

[DIA Europe 2023] Digital Transformation in Europe

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

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

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

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

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

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

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

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

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

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

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

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

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

DIA Europe Series

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

Presented by

About this talk

More from this channel