EUROPE March Brussels, Belgium CALL FOR ABSTRACTS. Join Us at the Crossroads of Healthcare. DIAglobal.org/Europe2020 #DIAEurope2020

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1 EUROPE March Brussels, Belgium CALL FOR ABSTRACTS Join Us at the Crossroads of Healthcare I1

2 Steering Committee Francis Arickx INAMI, Belgium Matthieu Boudes EPF, Belgium Sini Eskola EFPIA, Belgium Sabine Haubenreisser EMA, EU Lenita Lindström-Gommers European Commission, EU Kristin Raudsepp Medicines Agency, Estonia Thomas Senderovitz HMA, DKMA, Denmark Chris Walker Amgen, UK DIA Europe reflects DIA s Strategic initiatives on thought leadership. The Four Critical Cornerstone Areas: Regulatory Science Translational Science Value & Access Patient Engagement I 2

3 Thought Leadership Streams : 9 Topics designed to advance health care outcomes through innovation across 9 core thought leadership streams Clinical Development Data and Data Standards Patient Engagement Pharmacovigilance Regulatory Science Translational Medicines and Science Value and Access Medical Affairs Chemistry, Manufacturing and Control (CMC) I 3

4 Abstract Topics EVOLUTION OF THE REGULATORY SCIENCE STRATEGY & AGENDA KEEPING PACE WITH HEALTHCARE Catalysing the integration of science and technology in medicines development Driving collaborative evidence generation improving the scientific quality of evaluations, developing and coping with new kinds of evidence. Advancing patient-centred access to medicines in partnerships with healthcare systems Addressing emerging health threats and availability/therapeutic challenges - regulatory collaboration and convergence in the EU and beyond Enabling and leveraging research and innovation - how does this impact regulatory standards? Regulatory science academic community - overview of regulatory science network in Europe Quality of the European regulatory system: a global competitiveness assessment Corporate social responsibility Competitiveness performance of the EU pharmaceutical industry how to support the development REGULATORY OPERATIONS - TECHNOLOGY AND INFRASTRUCTURE TRANSFORMING HOW WE WORK Automatisation of regulatory processes in industry or regulatory agencies how can we use the technology for the better? Telematics strategy in practice impact on regulatory operations and submissions From e-pil to no-paper-pil pros and cons for replacing the PI on paper From paper to e-prescriptions Initiatives from NCAs and HMA Availability problems of medicinal products how to prevent and mitigate FROM PERSONALISED MEDICINES TO PERSONALISED HEALTHCARE - THE CHANGING EXPECTATIONS AND ROLE OF STAKEHOLDERS WITH PERSONALISED MEDICINES End to end R&D processes support Bioethics with novel technologies: CRISPR babies and beyond where are the limits? New data sources from new technologies: Gene editing, genome sequencing, rapid microbiological methods, digital endpoints, including clinical care data - what is needed to foster of access and acceptance? (e.g. fit-for-purpose data quality standards for RWD, healthcare data sharing) From indication-based labels to a new era of evidence generation what are the future roles of regulators and HTA bodies? Development challenges with small populations - what are the future concepts (e.g. CT designs, modelling & simulation, n=1, RWD) for regulators and HTA bodies? Learning Healthcare System - in the clouds or in practice? (e.g. advice along the development continuum, data analytics, cloud based assessments) The healthcare future is digital, genomic and collaborative - how can pharma, medical device and IVD pathways be integrated? Advanced therapies, novel technologies and personalisation of healthcare: Are transformative innovations and system efficiency incompatible? Incentivising the personalisation of care: What is the role of innovative pricing and reimbursement models? VALUE AND ACCESS - EMERGING TRENDS IN HTA AND MARKET ACCESS Why parallel advice is needed (HTA principles explained, the major EU HTA archetypes and why they have different requirements versus regulators)? Experience with parallel - SA, what works what doesn t and what is needed beyond 2020 What next for HTA post Streamlining the HTA assessment beyond EUnetHTA/ Future of HTA assessment or other value evaluation what fits the future therapies? Encouraging the use of RWE, Monitoring outcomes - Case studies from managed entry agreements in Europe what works, what doesn t? A patient centric approach to HTA - integrating patient voice into value discussions how do we get there? How to manage affordability - the tension between ever more exciting and relevant technologies and limited healthcare budgets. A joined up approach HTA and market access beyond pills and injectables, how to we allow for combination products integrating e-health, devices and diagostics? I 4

5 Abstract Topics ADVANCES IN CLINICAL SAFETY AND PHARMACOVIGILANCE PV automation - call for demos, cloud storage, etc. Automated processes for regulators Globalisation in PV Capacity building in PV The WEB-RADR 2 project: outcomes after 28 February 2020 EudraVigilance: Inspections and status quo after the implementation of the new system Patient involvement in development and safe use of medicines Falsified Medicine Directive: One year after implementation impact on safety and PV Medical Devices Regulation are you ready? Predictive safety safety biomarkers; systems pharmacology; network models; data pooling Mobile Apps / wearables oversight, regulations and requirements CLINICAL TRIALS - INNOVATIVE TRIAL DESIGN, EVIDENCE GENERATION AND PREPARING FOR THE CTR Clinical Trial Regulation: State of play at Member States level - Experiences and lessons learned from pilots Innovative early CTs: complex trial design - Experiences and challenges with running the innovative clinical trial with case studies from ATMPs Data Transparency in Clinical Trials Clinical Trial Facilitation Group (CTFG) updates New Clinical Trial Regulation are we ready? CLINICAL OPERATIONS AND DOCUMENT MANAGEMENT Challenges of risk-based monitoring and how to achieve data integration from disparate sources Adaptive Trial Design - quick adaptation of new study designs to reduce the cost of clinical trials and flexibility to respond to new drug supply requirements Digital and site-less trials or digital patients and innovative ways to engage and inform patients Moving towards patient-focused endpoints, patient-reported outcomes, patient-centric trials Automation in clinical trial operations - using technology to increase productivity in Clinical Trial Supplies, Clinical Trial Logistics, Clinical Supply Operations, Clinical Labelling & Packaging TMF, etmf and innovations in document management Artificial Intelligence and Machine Learning in document management MEDICAL AFFAIRS AND SCIENTIFIC COMMUNICATION - ADVANCES IN THE SUPPORT OF A CHANGING HEALTHCARE SYSTEM Improved engagement with healthcare professionals and clinicians Medical Affairs value and cross-functional collaboration with healthcare professionals and patients Reputation management in the era of social media Adopting new technologies in scientific communication Risk-minimisation materials and Medical Information role in education Impact of compliance rules on ability to communicate on medical matters with stakeholders Presenting valid scientific information about vaccines in louder and best understandable way I 5

6 Abstract Topics NOVEL DATA SOURCES: WHERE WILL THEY COME FROM AND HOW WILL THEY ENABLE IMPROVED HEALTHCARE Developing a common data sharing model Case studies in applying artificial intelligence or machine learning in industry or within other stakeholders (regulators, payers, healthcare providers) Putting big data into practice call for examples EMA-HMA Big Data Task force update RWE/RWD use in health care and regulatory decision making AI based solutions to health care issues automation vs innovation what may deep learning add? Data Ethics including data ownership, sharing, trust, privacy and transparency Blockchain as a new tool in healthcare Data use to support development of new therapies Case Study- 3D printing of drugs how does this match with traditional drug development- a new challenge REGULATORY CMC AND PRODUCT QUALITY - ADVANCES IN MANUFACTURE, QUALITY AND SUPPLY Blockchain and other technologies in technical development / manufacturing 3D printing of medicines and its impact on industry, regulators and dispensers Digitalisation of quality and manufacturing processes Shorter supply chains for future therapies: point of care manufacturing and other examples Recent developments within ICH Quality topics Increasing quality standards in manufacturing in the rest of the world: impact on Europe s manufacturing competitiveness FUTURE REGULATION OF DEVICES, COMBINATION PRODUCTS AND DIGITAL Taking stock of the MDR and IVDR implementation Software as a treatment first experiences Companion diagnostics to enable more precise prescribing do they save money? Medical device surveillance and its impact in Europe and globally Evidence generation and assessment for devices Regulatory system changes needs to allow for approval of combination products Use of apps and impact on patient reported outcomes Value-based healthcare for medical device and imaging companies Regulatory approval of combination products under MDR and IVDR: Medicine Authority and Notified Body readiness and revised systems REGIONAL UPDATES AND EU INSIGHTS PROFESSIONAL DEVELOPMENT 1. Regional/Country Updates Eurasia (including Russia) Turkey Japan China ICMRA WHO Middle East Africa 2. Brussels Public Health Agenda for 2025 Women in leadership Increasing diversity in the organisation Leaders of tomorrow Career development From functional expertise to broader management and leadership Patient-centric drug development from bench to bedside changing organisational approaches I 6

7 Speak at Submit an Abstract Deadline: 10 June 2019 Get Involved. We are looking for global, interdisciplinary, cross-functional content with real-world applications. DIA invites you to submit presentation, session and short course abstracts for DIA Europe in Brussels, March You may submit more than one. Abstracts should fall under one of the topics detailed on the following pages. Session Abstract (75 mins) A session abstract is delivered lecture-style from the podium. The abstract author acts as session chair to coordinate efforts in recruiting speakers and manage the session (including the facilitation of question and answers from the audience). PowerPoint presentations are required. Presentation (20 mins) A presentation abstract is a presentation covering a specific topic area, and the speaker is the abstract author. Workshop (60 or 75 mins) A workshop abstract is designed for hands-on learning with a focus on application. The abstract author is considered the workshop chair and ensures the workshop provides onsite learning in the form of activities or demonstrations, including handouts. Forum (60 mins) A forum abstract is designed for panel interaction and attendee engagement. The abstract author acts as forum chair, recruiting panel participants and ensuring good representation/diversity in their selection. PowerPoint presentations are not required. Short Course (180 mins) A Short Course is a hands-on, interactive learning experience for a group of A Half Day Short Course consists of 3 hours of instruction. The short course will have a lead instructor and no more than one co-instructor. How to maximise the probability of your abstract being accepted Abstracts will be selected by the DIA Europe Programme Committee. Focus your abstracts on the proposed topics in this flyer. If your abstract clearly does not fit, submit it as a hot topic/stand-alone presentation or session Your abstract should be as clear and as detailed as possible to enable the theme leaders to make a judgement on its suitability for the programme Abstracts must be non-promotional and non-commercial in order to be considered If you have any questions about abstract submission, please the DIA Europe team: Basel@diaglobal.org How to Submit an Abstract All abstracts have to be submitted online at The deadline for submitting abstracts is Monday, 10 June 2019 I 7