T-Cell Engagers (TCE’s) are one of the most promising treatment modalities for the cure of multiple, solid and hematological tumors which we earlier thought were incurable diseases. Due to the mechanism of action of these molecules, whereby, it engages T-cells towards the target cancer cells, it sometimes causes hyperinflammatory conditions releasing cytokines affecting multiple organs/organ systems. The mechanism behind the cytokine release in such conditions is known. Its diagnosis and treatment, however, is challenging and require continuous monitoring to ensure the appropriate management of this severe condition before it starts deteriorating or affecting multiple organs. Since the early diagnosis of CRS is primarily based on clinical acumen, the available CRS grading criteria drive the diagnosis and management. Although CRS grading criteria have the common objective, primarily targeted towards an immediate management of the event, consensus towards a single grading criterion might vary. My presentation will be based on a review of published literature and comprises 3 parts:
- Comparing CRS grading methodologies, observations, and features driving the conclusion. - Justification towards an early management and mitigation plan based on available CRS grading
criteria
- Discuss best practices and potential areas for further follow up/improvement to ensure optimal
patient safety.

Cytokine Release Syndrome (CRS)- Severity grading criteria and it’s management modalities

Small treatment groups present a challenge for safety analysis, especially in early development and for rare diseases. It is the known dilemma of finding the right equipoise with regards to sample size in order to get treatments to patients faster and at the same to have an adequate safety data package for a proper benefit-risk assessment and risk minimization planning. To address this challenge a new tool was developed. It integrates current safety data and historical safety data using Bayesian borrowing. The historical data is used to construct a robust meta-analytic predictive (MAP) prior which is then combined with the data from the new study to generate the posterior evidence. In contrast to simple pooling of safety data the robust MAP prior accounts for heterogeneity between different data sources and will automatically down-weight the historical information in case of prior data conflicts.
 At the same time, B-Safe is an easy-to-use tool that does not need much training. The tool interactively guides the user through the analysis. The user can choose between two safety data estimands: incidence proportions and incidence rates per treatment year to account for differences in treatment duration. Point estimates and credibility intervals are provided per treatment and for risk difference and risk ratio between treatments.
 In the session we will present the new analysis tool. Results of a retrospective analysis of a clinical trial will demonstrate its innovative and valuable use in safety analysis that supports informative decision making. Additional features are planned for the tool to extend its future use, e.g. in-time monitoring of safety data.
 With digital innovation we are increasing the precision of our judgements, shortening the time from observations to insights to action, which ultimately leads to offering better treatments to patients without undue delay.

An innovative easy to use tool to enhance robustness and precision of safety analysis with historical controls

EPARs were compared with the European Pediatric Medicines Database. Central marketing authorizations (MAs) for pediatric indications were divided into two periods: P1 - 1996–2008; P2 - 2009-2021 and evaluated by number and type of products approved, orphan designation and ATC classification.

Pediatric Drug Development: Trends and Perspectives in the European Union Five Years on from the European Commission’s Report

Drug repurposing matured in the last decades as a strategy to identify new indications for well-established molecules to address unmet medical needs. The Covid-19 pandemic highlights its importance as a potential strategy to deliver safe, effective and affordable medicines with significantly shorter timelines compared to traditional R&D. Repurposing can be applied across a wide range of diseases, including those where other R&D approaches have failed to provide solutions for patients (e.g rare tumors or neurological diseases). This opportunity was recognized by policymakers in the Pharmaceutical Strategy for Europe and with the STAMP pilot project, which will inform possible regulatory action for the promotion of drug repurposing.
 Despite promising policy steps, increasing funding and research attention, systemic inefficiencies for repurposing in the EU remain: 1) a fragmented and siloed R&D environment without an identifiable value chain for patient-centric repurposing; 2) heterogeneous quality and access to reliable computational tools using standardized datasets; 3); health technology assessment, pricing and reimbursement barriers; 4) non-alignment of the regulatory landscape with repurposing needs.
 Thus, more is needed to promote specific evidence generation efforts, address the issue of off-label use of repurposed medicines and build a policy environment that facilitates and rewards continuous innovation on well-established molecules.
 This session will bring together regulators, patient advocates, policy makers and industry representatives to explore how to advance the European repurposing ecosystem. Panelists will build on the lessons learnt to date from the STAMP pilot to assess how the regulatory landscape should evolve and identify sustainable strategies to bolster repurposing in the EU. A particular focus will be on enablers of long-term synergies, such as the recently-launched EU Horizon funded REMEDI4ALL platform.

Medicines repurposing: moving from an emergency solution to a sustainable strategy to address unmet medical need

Patients’ Organizations: A Global Overview
Patients’ Organizations have become an important stakeholder in health sector during the recent years. “Nothing about us without us” is a sounding quote that characterizes the patients’ share of voice and necessity for involvement in the development of medicines, market access and health policy in general.  The establishment of Patients’ Organizations is considered as the more significant means of patients’ advocacy and amplifying their voice. Such associations have been initiated globally around. They unite patients towards a more patient-centered approach in healthcare.
Purpose of this poster is to provide an overview of the patients’ organizations status world-wide. To achieve this, data regarding the members of International Alliance of Patient Organizations (IAPO) were retrieved.  Despite the geographical classification implemented by IAPO (Europe, Africa, Eastern Mediterranean, Latin America & The Caribbean, North America, South-East Asia, Western Pacific, International), a geographical re-classification took place to depict the more traditional classification per continent: Europe, North America, Asia, Latin America & The Caribbean, Africa, Australia.
In Europe, there are 101 Patients’ Organizations as members of IAPO. The majority of them (27) are cross-disease associations. 6 Patients’ Organizations are devoted to Cancer while Immune and autoimmune diseases, Diabetes, Psoriasis and Heart-related disorders count 4 associations each. Other organizations are related to the following causes or conditions, with their corresponding numbers: Infertility (2), Hepatitis (1), Dementia (2), Epilepsy (2), Osteoporosis (3), Rare-diseases (3), Kidney-related disorders (2), Skin-related disorders (3),  Dupuytren (1), Genetic-related disorders (2), Arthritis/Rheumatism (1), Pain (3), Multiple Sclerosis (3), Chronic-diseases (2), HIV/AIDS (2), Bowel-related disorders (1), Migraine/Headache (1), Lung-related disorders (2), Mental health disorders (1),Plagiocephaly (1),  Bladder-related disorders (2), Thalassemia (1), Endometriosis (1), Leukemia & lymphoma (1), Metabolic disorders (2), Sleep disorders (1), Blood disorders (1), Thrombosis (1), Addiction (1), Muscular Dystrophy (1), Growth disorders (1).
In North America reside 25 Patients’ Organizations in total as IAPO members. Similar with Europe, most of them (5) are cross-disease associations. Immune and autoimmune diseases, Rare diseases, Heart-related disorders and Skin-related disorders count 2 organizations each. One organization is devoted to each one of the following causes or conditions: Cancer, Infertility, Hepatitis, Diabetes, Genetic related disorders, Arthritis/ Rheumatism, Chronic diseases, Mental health disorders, Bladder-related disorders, Blood disorders, Disability and Lupus.
In Asia, 35 Patients’ Organizations are members of IAPO. 15 associations are cross-disease, 6 are related to Cancer, 3 to Thalassemia and 3 to Immune and autoimmune disease

Patients’ Organizations: A Global Overview

Objective: China has proactively adopted regulatory science (RS) to advance its regulatory capacity for advanced therapy medicinal products (ATMPs) but the reporting is scarce. The study aimed to identify the core actions in advancing RS and summarize the recent development of ATMPs in China.
Method: A mixed approach of documentary analysis of government policies, regulations and official information about ATMPs regulation in China, and a scoping review of the clinical registration, marketing application and approval of ATMPs from the Center for Drug Evaluation of NMPA (CDE) was employed.
Results: The first Regulatory Science Action Plan (RSAP) in China, first launched in 2019 and later updated in 2021, repeatedly emphasized on developing new regulatory tools, methods and standards for the technical evaluation and regulatory approaches of cell and gene therapy products. The scope spanned across quality control, non-clinical research, clinical study design, clinical outcome evaluation, as well as the use of real world data to improve regulation quality and efficiency. Since the RSAP, the review and regulatory systems and standards for ATMPs are constantly reviewed, specific consultation papers on different ATMPs (such as CAR-T (n=1), stem cell (n=2), immune cell (n=2), and gene therapy (n=1)) have been circulated and 9 technical guidelines specific to cell and gene therapies have been issued (such as CAR-T (n=1), immune cell (n=2), gene therapy (n=5), and oncolytic virus (n=1)). According to CDE, the number of ATMPs currently registered at the CDE is 151 (CAR-T (n=56), oncolytic virus (n=30), stem cell (n=24), gene therapy (n=22), other cell therapies (n=19)), of which 115 have been registered since RSAP. Most ATMPs under investigation are cancer-related (n=107), with CD19 (n=43), BCMA (n=8) and CSF2 (n=7) being the most common targets in clinical studies. As of 2003, the number of clinical trial applications for ATMPs as a new drug was 265 (antineoplastic drugs=199, immune system drugs=46), of which the number after RSAP was 173.
Conclusion: Advancing RS helps promote the advancement of the regulatory and technical evaluation systems of ATMPs in China, facilitating scientific regulation and regulatory standardization. The development of ATMP is still at an early stage. Strategically adopting RS to promote the successful clinical translation of ATMP innovation may also benefit reaching consensus across different drug regulatory authorities (DRAs).

Advancing regulatory science for developing advanced therapy medicinal products in China

RCT data is the corner stone of drug development, however, proposed patient groups are rarely homogenous in nature and patient groups, payers and regulators are increasingly demanding that companies accurately reflect this heterogeneity in RCTs, increasing the accuracy of outcomes and the predictive nature of the risk-benefit profile of an approved drug, especially in under-represented demographic groups. There is emerging evidence that race, ethnicity, age, sex and gender can influence the risk:benefit profile of a drug in terms of effectiveness v adverse drug reactions, which can be governed by pharmacogenetics. It is important nuances within subjects are identified early in the drug development pathway, and this includes the utilization of tools available to ensure you capture data from a diverse pool of individuals. Firstly, life science companies need to address historical mistrust in clinical research, which is still prevalent in some communities as evidenced by the issue of vaccine hesitancy throughout the Covid-19 pandemic, in underrepresented ethnic groups, who also suffered disproportionately higher rates of death and mortality. How we use technology has gone through a paradigm shift, with telemedicine and remote monitoring becoming necessary during the pandemic (decentralized trials). Herein lies an opportunity to capitalize on digitalization, alleviating patient burden (e.g. non-invasive monitoring), developing culturally-specific communication (e.g. e-consent), bringing the trial to the patient (e.g. reducing travel costs), increasing the diversity of participants. There is also an opportunity to leverage cross-border regulatory efforts, accepting more inclusive real-world trial eligibility criteria, especially regarding laboratory cut-offs that disproportionality affect communities with higher incidences of co-morbidities – associated with lower socio-economic status. The onus is now on stakeholders to bring the trials to these patient groups.

Diversity, Equity, and Inclusion (DEI) in Clinical Research – a Paradigm Shift

The Clinical Trial Regulation (Regulation (EU) No 536/2014)* simplifies the application process and increases transparency of clinical trials in the EU. It aims to harmonize the preparation, submission, review of clinical trial applications (CTAs) and the conduct of clinical trials. It applies to all interventional clinical trials regardless of whether conducted in one or several EU Member States.
 
 As of end of January 2022 (EU wide harmonized) CTA dossiers can be submitted via Clinical Trials Information System (CTIS), a new single EU portal/database overseen by the EMA. Submission will be followed by a collaborated assessment conclusion and decision for both Health Authorities (HAs) and Ethic Committees (ECs) within the EU via CTIS. The one-year transition period started on 31 January 2022 and will end on 31 January 2023. During this period, Boehringer will run pilots under the umbrella of the new regulation. The Regulation also defines harmonized criteria for authorization process, safety reporting, labelling requirements and transparency/publication rules throughout the EU.
 
 In this presentation on we share our approach to implement the Clinical Trial Regulation in a structured and pragmatic way within the cross-functional team at Boehringer Ingelheim to efficiently manage and leverage the new opportunities of the harmonized EU process. Corresponding to the presented approach, we will outline lessons learned and future outlook of the efficient management of Clinical Trials under EU CTR.
 
 *https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trial-regulation

Strategy on Implementation of EU Clinical Trial Regulation – Lessons learned by the first submissions at Boehringer Ingelheim

Otsuka Global Regulatory Affairs has developed a CTA Planner (CTAP) that manages EU CTA submissions and correspondence to optimize processes, ensure accurate data, forecasting, portfolio transparency, and facilitate CTA-monitoring coverage (CTIS does not generate external notifications).

CTAP is integral in supporting EU CTR 536/2014 because it assists with planning and managing EU CTA submissions and correspondence using centralization and automation. Notably, CTAP enables EU CTA document planning and metadata compilation by multiple functions within an internal centralized tool prior to uploading in CTIS. Specifically, CTAP allows internal contributors as well as external CROs to populate metadata forms that mirror CTIS data and required documents. This centralization provides a single point to manage tasks, including preparing CTIS submission requests; assigning functional areas; providing CTIS data, documentation, and timelines; logging/resolving issues; and tracking submission and document workflow status. This also eliminates CRO need for CTIS access, which reduces the complexity of user management when there are multiple CROs. Additionally, automation allows collection of metadata subsets for use in project planning, scheduling, oversight, and metric reporting.  CTAP generates auto-notifications to contributors and QC reviewers, and provides status updates for pending and completed tasks.

Further, to overcome CTIS limitations related to user notifications, each EMA notice / alert is logged and linked to the related CTA submission in CTAP. Automated workflow for the logged notice or alert prompts the relevant functional area to acknowledge awareness and initiate a response if required.
CTAP is an innovative Otsuka global submission tracking and management tool that promotes quality, efficiency, and accountability in the CTA submission process through time-saving features such as automated notifications, tracking and updating workflows, capturing audit trails, and data analytics, all of which allow Otsuka to be one of few companies to immediately operationalize EU CTR upon CTIS going live on 31Jan2022. By utilizing CTAP, Otsuka has received authorization for a submitted CTA consisting of 10+ countries with 800+ documents. Recent CTAP enhancements include CTA progress dashboards, interactive user-friendly metadata e-forms, the ability to request multi-trial submissions such as Annual Safety Reports or CTA Modifications, and use of a distinct timetable for validation, evaluation, and Request for Information (RFI) timelines.

The authors wish to acknowledge Boris Reznichenko and Sasikanth Godavarty for their support in making this system a reality.

EU CTA Planner (CTAP): A Tool to Plan and Manage EU CTA Submissions and Correspondence in Support of EU CTR 536/2014

The first step was to establish a multi-stakeholder advisory board of patient representatives, clinicians, and method experts to guide attribute and level development. Following the PREFER recommendations, this was based on a literature review and previous qualitative data, and clinical trial data.

Patient Preferences in Duchenne Muscular Dystrophy: Developing Attributes and Levels for a Quantitative Survey

Objective: This study aims to i) evaluate the association between EU regulatory measures and national market access measures and ii) assess the impact of regulatory measures on the rate of and time to reimbursement of centrally authorised medicines in Belgium.
Methods: Included medicines were granted a European centralised marketing authorization between 2015 and 2020, excluding generic products/biosimilars. The association between the application of regulatory measures and market access measures is assessed in a logistic regression model (i) and the impact of regulatory measures on the time to and rate of reimbursement was tested via cox regressions (ii). 
Results: A total of 322 medicines were selected for inclusion of which the time to and rate of availability were calculated and the impact of regulatory measures assessed. Included regulatory measures were installed at the European level and relied on the unmet medical need concept as eligibility criterium. Analysis resulted in 79 (24.4%) medicines with orphan designation, 11 (3.4%) included in the PRIME scheme, 25 (7.7%) accelerated assessed, 22 (6.8%) conditionally authorized, and 11 (3.4%) authorized under exceptional circumstance, with some medicines applied a combination of these regulatory measures. Of all include medicines, 282 (88%) were submitted a dossier for reimbursement in Belgium, and 167 (52%) were reimbursed at the time of analysis, leaving 155 (48%) not reimbursed. (i) Logistic regression showed a positive association between the application of any regulatory measure and the application of any market access measure (i.e. compassionate use program, medical need program, managed entry agreement, or early temporary reimbursement) (p<.001). For individual regulatory measures, no significant association was found with the application of any market access measure, except for the accelerated assessment (p<.001). (ii) Two cox regression analyses were performed with varying survival intervals; a) the interval between marketing authorization application and reimbursement and b) the interval between submission of the reimbursement dossier and reimbursement. Predictors are the identified regulatory measures. No significant impact was reported of any regulatory measure on both a) the time and rate to reimbursement starting from MA application and b) the P&R assessment time.
Conclusion: Inclusion in expediting regulatory pathways often implicates a higher acceptance of uncertainties which can be justified considering the high need for those medicines. However, if the national payer/regulator does not agree upon the relative pressing nature of the respective need, the remaining uncertainties can be unacceptable, impacting pricing and reimbursement decisions. This study found that medicines that obtained any regulatory measure by the EMA are more likely to also obtain any included market access measure in Belgium, possibly indicating alignment in prioritization between the EMA and the Belgian

IMPACT OF EXPEDITING UNMET MEDICAL NEED REGULATORY MEASURES ON REIMBURSEMENT OF MEDICINES IN BELGIUM 

Background: There is a growing consensus across stakeholders on the value of patient preference (PP) studies, as recognized by the European Medicines Agency and the European Network for Health Technology Assessment. This study aimed to develop a PP survey to quantitatively evaluate which characteristics are most important to inflammatory bowel disease (IBD) patients, so that the results can inform the medicinal product life cycle (MPLC).
Methods: Following the PREFER recommendations, a four-step approach was followed to develop the PP survey: 1) stated preference method selection, 2) attribute and level development, 3) survey implementation, and 4) survey piloting. Throughout the different steps of the survey development, an advisory board (AB) consisting out of patients, patient organizations, gastroenterologists, IBD nurses, and statisticians were consulted.
Results: First, a discrete choice experiment (DCE) was chosen as the preferred elicitation method because it allows to reach the objectives of the survey, namely to: 1) quantify the relative importance of different attributes, 2) elicit the trade-offs patients make, and 3) measure preference heterogeneity. Second, a scoping literature review of IBD clinical trials, available IBD treatments, and previously published preference studies was performed. Discussions on these characteristics with patients (n=11) during focus group discussions (FGDs) using the nominal group technique revealed the following patient prioritized characteristics: prevent surgery, long-term clinical remission, improved quality of life, occurrence of urgency, and improved labor rate. Based upon the results of the FGDs, a preliminary list of possible attributes for inclusion in the DCE was refined during AB meetings. This list was iteratively adapted until consensus was found on 14 attributes, their levels, and corresponding explanations (Figure 1). Third, the DCE survey was designed to include these 14 attributes using partial profiles next to measures about sociodemographic variables, health literacy, and treatment experience. Fourth, piloting the study with IBD patients (n=4) revealed that the survey was comprehensible, had a good flow, and contained graphics that supported the content. Only minor text edits were needed.
Conclusion: It is key to develop a PP survey in partnership with patients and other members of the AB. This survey will be rolled out across Europe in 11 different languages and will increase understanding of which treatment aspects are most important to IBD patients. These aspects should be included in drug development and evaluation so that the MPLC can be more patient-centered and future treatments will target aspects that are most important to IBD patients themselves.

Patient preferences for inflammatory bowel disease treatments: development of a European preference survey

Research is focused on patients with rare treatment-resistant catastrophic epilepsy syndromes such as Dravet syndrome , LGS, Doose syndrome, CDKL5 deficiency disorder (CDD), infantile spasms (IS), tuberous sclerosis complex (TSC), to name a few developmental and epileptic encephalopathies (DEEs).

Focus on Patient Journey in Rare Disease Research: Epilepsy Syndromes

Through a partnership between different stakeholders, an innovative Patient Safety & Pharmacovigilance program focusing on healthcare professionals working in medical institutions has been developed for implementation worldwide based on a successful previous experience in Brazil.

Patient Safety & Pharmacovigilance program for enhancement of patient safety system in medical institutions

Email outreach to Biopharmaceutical, CRO, and other individuals to complete a 5 minute, 16 question online survey in July 2022.

The Shifting Terrain - Trends in Use of Hybrid and Decentralized Trial Methods

Contracts for commercial partnerships usually also detail regulatory obligations. Adequate and smooth fulfillment of these obligated activities calls for knowledge sharing between both parties as well as within internal functions with often disparate information management systems. We implemented a cross-functional process for knowledge-sharing supported by an integral part of our Regulatory Information Management (RIM) solution. As a result, we could interlink the contractually obligated regulatory activities with our RIM data and this now allows for improved oversight and tracking of shared partnership tasks. We will present our strategies for achieving this and demonstrate the solution now in production.

Tracking contractual obligations in a RIM system

For the last 20 years, organizations have been discussing the
need to think differently how their workforce shows up.
Historically, three topics have been discussed and setup (in
the organization and in their ERP/system ecosystem): 1.
Preparing the workforce for the future: with the impact of big
tech and of major technological shifts in the world, work and
how it is done has been reshaped radically. Organizations
have lagged in this aspect and have tried to catch up by
having Strategic Workforce Strategies that mostly focus on
the people side, but does not necessarily match it with the
business needs (new capabilities, new value propositions). 2.
With a fast renewal of the workforce (millennials, gen Z
coming to the workforce) that have different drivers and
expectations of what work means, organizations have
historically struggled to understand how to reshape their org
structure from a hierarchical top-down setup, to an flexible
setup. Going through strong reorgs removing layers of
management, shifting to matrixial structures, etc. the intent
has always been to move from fixed roles and job
descriptions to a more 'gig' setup, where the skills based work
is the driver. This has not been successful as it is increasingly
difficult to match the 'old' skills in orgs with the 'new' skills in
the market and 'intangible' skills are difficult to map within the
org and externally. 3. Personal development paths: the
biggest challenge in orgs has been to be able to match the
individual development goals, with the org's business needs.
Through a data-informed SWP framework, where all three
elements come together, Senior leadership can have
informed options of what the org will need; skills mapping is
redefined to allow float of talent across functions and roles,
which enables an integrated personalized career path
offering. Through some use cases, the audience will be able
to see 'live' how the three bring more value than the current
approaches.

Preparing for the future of Pharma: a data informed framework for strategic workforce planning

Abstract
Industry is committed to developing new medicines for patients and conducting clinical trials to assess the safety and efficacy of unauthorised medicines. Clinical trials are the most common route for patient access to unauthorised medicines, however, patients with life-threatening or seriously debilitating illnesses who have exhausted all available treatments, and are ineligible or unable to participate in a clinical trial may seek access to unauthorised medicines. Such pre-approval access is referred to as compassionate use in the EU. During the last revision of the EU pharmaceutical legislation in 2003, the European Commission introduced the Article 83 of Regulation (EC) No 726/2004, which allows the use of an unauthorised medicine to patients with no satisfactory authorised therapies and who cannot enter clinical trials. Twenty years have passed since the last revision of the pharmaceutical legislation and only 6 CHMP opinions were issued on compassionate use by EMA/CHMP. Despite Article 83, there is high variability and significant differences in the requirements and level of guidance given, which currently leads to inequity of patient access due to the following factors:
• Delayed patient access.
• Inequity in patient access and duration of access.
• Significant variability in local medical practices.
• No or inconsistent data collection.
• Slow and fragmented response to emergencies.
• Inconsistent regulations across countries.
There is a huge opportunity to improve this important regulatory pathway. By improving this regulatory pathway, we can achieve convergence and harmonisation of compassionate use programmes across the EU.

A pressing call for harmonising Compassionate use in Europe!

All CAR-T drug that have received marketing authorisation by the European Medicine Agency were included in this analysis. Early access conditions have been retrieved from the relevant national authorities as of October 2022 and analysed from a qualitative perspective.

Early health technology assessment conditions for CAR-T therapies in France in light of recent and upcoming reforms

AI-ML enabled medical devices is a fast-moving field still subject to many speculations. Analyzing the AI/ML regulatory approvals landscape, based on regulatory precedents, will help inform regulatory strategies and showcase important aspects that supported the regulatory decisions.
What is the most common approval pathway? the average approval time ? In which area are we seeing the most of approvals? What medical devices classification was the most represented?
For all AI/ML-based medical devices listed on the FDA database, the following characteristics were collected: device name, manufacturer, review panel, regulatory pathway, time for approval, Regulatory MD classification, regulation name. Time range goes from 11/08/1995 to 07/29/2022

A review of Artificial Intelligence and Machine Learning (AI/ML) - Enabled Medical Devices approvals in the US

Semi-structured interviews were conducted among the Belgian vaccine-eligible population. Participants were asked to complete a ranking exercise in which they could rank certain vaccine features based on importance. The interviews were transcribed and analyzed using thematic framework analysis.

Patient preferences among the Belgian population for COVID-19 vaccines: A qualitative study

This study was conducted as part of the IMI project Gravitate Health and consisted of a literature review of available product information. Further, the Patient Health Engagement model was applied to align the delivery format of the product information with patients’ literacy and engagement levels.

Digital product information tailored to patients’ needs based on a theoretical framework of behavioural change

Identifiers for both drugs and medical devices in the U.S. are going through some transition. The Unique Device Identification System final rule (UDI Rule) requires device labelers to include the UDI on device labels and packages, except where the rule provides for an exception or alternative. Drug are assigned a unique identifier called the National Drug Code (NDC). All drugs in U.S. commercial distribution are required to be listed with the Food and Drug Administration (FDA) using the NDC. In this session, the latest update on the transition for each identifier is discussed, and all the compliance dates and requirements surrounding the transition will be provided.

Format of the National Drug Code in the United States

Measuring the prevalence and impact of Patient Engagement (PE) initiatives implemented to inform and enrich clinical trial planning and execution has been a longstanding challenge. Despite calls to consistently track usage and quantify
the impact of patient engagement initiatives across both sponsor companies and contract research organizations (CRO), systematic efforts to do so have continued to lag.

Benchmarking Patient Engagement Capabilities and Preparedness of Drug Development Sponsors

For it's 35th anniversary, DIA Europe is back in Basel, where all thought leaders meet in person to discuss, inspire, and network.

Join us in Basel: March 22-24, 2023

DIA Europe 2023 is designed to drive insights into action by connecting key policy discussions to real-world knowledge that you need for your everyday job. Your participation will accelerate your growth and your organization's performance in the drug development ecosystem.

Gathering innovative thought leaders from the entire life science landscape, DIA always has the aspiration to be ahead of current developments, reflected by 4 new content tracks in 2023:

- Artificial Intelligence and Data Science
- EU Health Policy and Regulatory Strategy
- Medical Devices and Combination Products
- Professional Development

DIA Europe 2023

A global, member-driven non-profit organization mobilizing life sciences and healthcare. DIA fosters innovation to improve health and well-being worldwide. Professionals from 80 countries continue to engage with DIA through our unparalleled membership network, educational offerings, and professional development opportunities.