EMA: Joint HMA/EMA workshop on artificial intelligence in medicines regulation
Artificial intelligence (AI) and novel digital technologies hold the promise of increasing efficiency and capacity in healthcare and of providing deeper insights from big data. The HMA-EMA Joint Big Data Task Force recommended to Strengthen the Network ability in AI, which is reflected in the Big Data Steering Group work plan.
The objective of this workshop is to:
> Inform on state-of-the art use of AI in medicines with keynote presentations;
> Hear the views of stakeholders and experts on the AI actions in the Big Data Taskforce and identify any gaps.
Nordic Life Science Days 2021
EMA: Joint HMA/EMA workshop on artificial intelligence in medicines regulation
Artificial intelligence (AI) and novel digital technologies hold the promise of increasing efficiency and capacity in healthcare and of providing deeper insights from big data. The HMA-EMA Joint Big Data Task Force recommended to Strengthen the Network ability in AI, which is reflected in the Big Data Steering Group work plan.
The objective of this workshop is to:
> Inform on state-of-the art use of AI in medicines with keynote presentations;
> Hear the views of stakeholders and experts on the AI actions in the Big Data Taskforce and identify any gaps.
SCRS: European Site Solutions Summit
The European Site Solutions Summit is the best place for sites, sponsors, and CROs to come together to learn, communicate and collaborate about the latest knowledge, trends and best practices shared by experts in the EU region. The meeting offers tremendous value to attendees by providing educational tools, networking opportunities and creating partnerships and relationships between sponsors, CROs and sites.
IVO: SciCommLunch ‘Het vergroten van de impact van je onderzoek met wetenschapscommunicatie’
Het vergroten van de impact van je onderzoek met wetenschapscommunicatie. Hierover gaat de #SciCommLunch. Deze keer is dr. Joanneke van der Nagel te gast. Zij vertelt over ‘Normaal doen voor Academici’. Waarom is dat eigenlijk belangrijk? En waarom is het zo moeilijk? Wat gebeurt er als zorgverleners en wetenschappers NIET normaal doen? En hoe kunnen we academici helpen om wat normaler te worden? Je kan als deelnemer lekker luisteren naar het vraaggesprek of zelf vragen stellen. Ben je erbij? Elke maand organiseert het IVO een #SciCommLunch met een andere ‘special guest’ die actief is op het gebied van wetenschapscommunicatie of het toegankelijk maken van onderzoeksresultaten voor een breder publiek dan alleen wetenschappers. Bijvoorbeeld als blogger, podcastmaker, in de media, op social media of presentaties voor het algemeen publiek.
JPIAMR and UK MRC: Feeding the AMR Therapeutics Pipeline
NEN: Schrems II, Brexit en het gebruik van de cloud.
UKRIO: An Introduction to Research Integrity (webinar)
The next webinar in the series of monthly sessions from the UK Research Integrity Office will be An Introduction to Research Integrity, discussing key issues relating to good practice in research and the challenges that researchers can face when ensuring that research is high quality and of high ethical standards. The webinar will be of particular interest to research students; early-career researchers; and team leaders, principal investigators, managers, supervisors, research integrity officers and others who wish to make sure their researchers are informed about issues of good research practice.
EViR – RoRI: The Research on Research Institute: progress & future plans
Purpose of Session: To provide an overview of the work of the Research on Research Institute (RoRI), an international consortium of funders, academics and technologists committed to transformative and translational research on research (or meta-science). RoRI is currently undertaking a number of projects and initiatives investigating key areas of the research ecosystem covering themes of research careers, cultures, and decision making.
Healixia: Digitization within Medicine, the Belgian eHealth case
EUCROF: EMA Clinical Trials Information System (CTIS) – Be ready before it goes live
As of December 2021, only 8 months from now, all scientific research with medicinal products in the EU need to be submitted via the Clinical Trial Information System, the CTIS. To make sure all future users of the CTIS system, both sponsors and member states, are familiar with the settings and way-of-working in the system, the EMA has setup a training program – consisting of both free e-learning material and a Master Trainer Programme instructing the company’s trainers to support implementation and use of the system. In this webinar, Marieke Meulemans shows what training material has been created, where to find it and supports your preparation in the use of the CTIS with useful tips and considerations. Attending this webinar makes you aware of the steps to take in the next 8 months to get ready.
(QUESTS) Improving randomised controlled trials through drawing: what creative methods can teach us about process and outcomes (Jenevieve Mannell)
There has been increasing interest in using creative methods as part of randomised controlled trials of health interventions, but what do these methods actually add to evaluation research? This webinar explores the value of creative methods, including drawing and mapping, for improving trial designs and building better understandings of trial outcomes. This is approached from a social psychological perspective where creativity and participation is valued for its ability to improve communication and mutual understanding between researchers and trial participations
EARMA’s 27th Annual Conference
EARMA represents the community of Research Managers and Administrators (RMAs) in Europe. Our members work in industry, academia, the public and private sectors. We work with the EU Commission, national and international funding agencies. EARMA provides a networking forum, a learning platform, and a place to share experiences and best practice among RMAs throughout EARMA and in the wider RMA community.
CDISC: 2021 CDISC Europe Interchange
The Virtual 2021 CDISC Europe Interchange will be held over two and a half days, 28 – 30 April. This year, the Europe Interchange and CDISC TechniCon will be combined into a single event, and attendees that register for the Europe Interchange will gain access to the TechniCon – get two conferences for the price of one!
3rd EUFEMED Conference”Exploratory Development of Novel Therapeutic Approaches – Focused strategies based on lessons learned in the pandemic”
The third EUFEMED CONFERENCE will be held on 28-30 April 2021 and is entitled: “Exploratory Development of Novel Therapeutic Approaches – Focused strategies based on lessons learned in the pandemic”. The conference provides a unique opportunity to hear about the pandemic experience from regulators, sponsors and those working in CROs. We invite you to join us.
PedCRIN webinar:Methods for the engagement of youth and families in paediatric clinical trials-Towards patient-centred studies
Our second session of the PedCRIN webinar series will be focused on patient engagement in clinical research, specifically on the involvement of families and young people. The speakers are Eric Vermeulen from VSOP (Dutch Patient Alliance for Rare and Genetic Diseases) and Begonya Nafria from FSJD (Sant Joan de Déu Research Foundation). In order to develop efficient paediatric clinical trials, it is essential to involve patients and families. Within the PedCRIN project, we have analysed different models of involving patients and families in academic studies. In this webinar, we will share lessons learned through the application of these models and will explain how you can plan patient involvement in your studies.
NFU: ‘Traceerbaarheid’ De verplichtingen ten aanzien van de registratie van medische hulpmiddelen en met name implantaten en de Implantaatkaart
PRIM&R: Webinar: (2021-4) Now Is No Time to Relax: Why the Global Pandemic Strengthens the Case for Considering Sex as a Biological Variable
Established five years ago in January 2016, the NIH policy on the Consideration of Sex as a Biological Variable (SABV) is a part of a global movement to integrate the study of sex into research. Considering SABV in research studies and reporting results by sex lead to a more complete knowledge base that improves rigor and reproducibility, a tenet of good science. Increased knowledge leads to more productive future research, more effective treatments, and better health for women (and men). The coronavirus pandemic has revealed critical gaps in our knowledge base, intransigent health disparities and health inequities, and runs the risk of reversing years of progress toward gender equity. It is a reason to redouble our efforts to apply NIH policies, fully integrate the study of sex into the research process, and support women’s advancement in biomedical research careers.
DARQA webinar “Pharmacovigilance for Non-PV QA”
Op vrijdag 30 april 2021 zal er een webinar plaatsvinden waarin Sarah Mills, Senior Manager Global Quality bij PRA Health in Engeland ons begeleidt in het pharmacovigilantieproces zoals je dat kunt tegenkomen bij het auditen van bijvoorbeeld onderzoekslokaties in klinisch onderzoek. Sarah heeft ruime ervaring op het gebied van pharmacovigilantie, opgedaan in het uitvoeren van supplier audits, interne PV system audits, support van PV audits uitgevoerd door klanten en met de ondersteuning van PV inspecties door overheidsinstanties. In dit webinar wordt een overzicht gegeven van wat pharmacovigilantie betekent voor GCP QA managers die zich niet specifiek bezig houden met PV concepten en processen maar wel regelmatig pharmacovigilantie-aspecten tegenkomen in hun werk als auditor.
EDPB: Stakeholder Event on processing of personal data for scientific research purposes
On April 30, the EDPB is organising a remote stakeholder event on the topic “application of the GDPR to the processing of personal data for scientific research purposes”. Representatives from, among others, individual companies, sector organisations, NGOs, law firms and academia with an expertise on the field are welcome to express interest in attending. Places will be allocated on a first come, first served basis, depending on availability. Nonetheless, the EDPB reserves the right to give precedence to specific stakeholders, in light of their relevance in the field. Selected participants will receive the confirmation of their registration in the event via e-mail. Detailed information and the programme of the event will be available shortly. As we would like to have a balanced and representative audience, participation will be limited to one participant per organisation.
eClinical Forum Virtual Spring Workshop
European Health Stakeholder Group: EU-UK transfers of data: implications for the European healthcare sector
What are the implications of EU-UK data transfers for the European health care sector? At this event, we tackle the challenge of international transfers of personal health data between the EU and the UK. The transfer of data is essential for many functions within the European health sector. These transfers facilitate the delivery of cross-border health and social care, aid the movement of healthcare professionals, and support our response to health threats such as COVID-19. The sharing of health data also facilitates cooperation on clinical trials and epidemiological research.
Virtual CASP Workshop – Critical Appraisal of Randomised Controlled Trials
Looking at what RCT’s are and how to read and understand them. Taking place over 3 ½ hours, the session will be lead by CASP Trainer, Erica Ison. There will be an introductory presentation, small group work appraising a published RCT paper, followed by group discussion and feedback.
ISBER 2021 Annual Meeting & Exhibits – Connect and Collaborate through Biobanking: Powering Innovation and Discovery
The theme of the meeting is “Connect and Collaborate through Biobanking: Powering Innovation and Discovery”
RAPS Euro Convergence 2021
RAPS Euro Convergence is an annual programme created by European regulatory professionals for regulatory professionals operating in Europe and other countries who want to comply with European regulatory policies. The programme provides a specific forum for leading experts and professionals in the medical device, IVD, and pharmaceutical industries to examine and provide insight on the most urgent and crucial issues facing regulators, manufacturers, and regulatory professionals working with healthcare products for the European market.
EJP RD: Rare Disease Biobanks: Roles in Research Networks and International Collaborations
The aim of the present training workshop is to emphasize the need for rare disease biobank networks to overcome sample scarcity and to draw attention to some of the challenges for collaborative research but at the same time also give examples of platforms, infrastructures and national activities that are catalysing national and international collaborations. It is hoped that at the end of this training course, lectures will highlight a checklist for the attendants as a guideline for biobank networks and research. This training is addressed to beginners.
Pistoia Alliance: Lab of the Future USA
There are profound changes taking place in life sciences R&D and that change is happening now. Research, driven by technological advances and the move towards the development of precision medicines delivered through collaborative partnerships has changed the very concept of what the lab is. The Lab of the Future Congress is a unique, large scale, multidisciplinary conference and exhibition. The event will help drive the successful incorporation and integration of new technologies and thinking into the lab that fosters creativity, innovation and medicines discovery and development.
Introduction to Trials within Cohorts (TwiCs)
The Trials within Cohorts (TwiCs) approach uses infrastructures (cohorts) to facilitate the efficient conduct of multiple randomised controlled trials. Introduction to Trials within Cohorts (TwiCs) image
In this short talk Dr Clare Relton will describe key features of the TwiCs approach to pragmatic trial design, and the origins of the approach. The talk will include a wide range of examples of UK and international studies using the TwiCs approach, different ways to approach informed consent, strengths and weaknesses of the TwiCs approach compared to the standard approach to pragmatic trial design. Other innovative approaches to trial design which use routine data sources will also be discussed(e.g. randomised registry trials, electronic health record/ point-of-care trials, administrative trials).
EUCROF: Staying Safe on the Way to Innovative Therapeutic Options -Phase I Trials
n the light of a global pandemic, clinical research in early-stage development reached a new degree of interest as the world relies on scientists to find solutions for unmet medical needs. Under the pressure of this scenario all parties involved in clinical research have to re-organise the working floor and find to ensure the utmost safety of trial participants while in parallel improve the productivity and speed. In drug development the most sensitive part is the switch from non-clinical to clinical conduct, namely the First-in-Human/First-in-Patient (FIH/FIP) Phase I clinical trials. To ensure utmost safety a trial specific risk analysis and risk-minimizing measures are required for trial design and protocol as well as for the translation into practical conduct for executing infrastructures in specialized Phase I research clinics. The basic principles of safety arrangements in clinical trials are regulated by international guidelines and local laws and requirements. For the EU countries the Clinical Trials Regulation 536/2014 based on ICH GCP E6 is implemented as binding law for the conduct of clinical trials. Since this law does not distinguish between the different phases of drug development starting with FIH/FIP Phase I up to confirmatory Phase III trials, the EMA took action in 2017 to update the guideline for FIH/FIP clinical trials which states that “the early clinical development of human medicinal products has an intrinsic element of uncertainty in relation to both the possible benefits and risks of a novel drug candidate”. This webinar will help to understand more about the risks and benefits of early-stage clinical trials conducted in specialized Phase I research clinics. It will highlight the points to be considered for planning and conduct of Phase I trials.
NewHoRRIzon Virtual Final Conference
H2020 project NewHoRRIzon – An experiment with responsible research and innovation. Our virtual final conference will share with attendees the achievements, tools and lessons learned in the H2020 project NewHoRRIzon. The programme includes focused breakout sessions for deep diving into specific RRI contexts, keynote lectures and presentations to reflect on the current status and future of RRI heading into Horizon Europe and plenty of networking opportunities to strengthen our European and global research and innovation community. We are excited to share our virtual RRI exhibition, where you can explore curated exhibits on our Social Labs, Pilot Actions, related projects and a variety of RRI topics.
NFU: ‘In-huis ontwikkeling’ Het ontwikkelen van medische hulpmiddelen voor eigen gebruik door een zorginstelling
UKRIO: Annual Conference 2021 (research integrity two-day event)
This conference is aimed at anyone with an interest in good research practice, research integrity, research ethics, improving research culture, ensuring quality and high ethical standards in research, or in addressing sloppiness or misconduct in research. The event will be of particular interest to researchers, research students and research administrators; people with managerial, supervisory or leadership roles in research; and people working in the fields of research integrity, research ethics, research culture, research governance or research policy.
UKRIO Annual Conference 2021 (research integrity two-day event)
Building on the successes of UKRIO’s monthly research integrity webinars, we have taken our annual conference entirely online. For the first time in its 8-year history, this free event will take place across two days, Wednesday 19 May and Thursday 20 May, with a deep dive into research integrity and “good research practice in a changing world”. UKRIO’s annual conference is the principal research integrity event in the UK and, since 2013, has been an essential resource for the research community and policy makers.
ECRIN: International Clinical Trials Day (ICTD) 2021- Platform Trials: Shift in treatment, testing and collaboration
In light of the current pandemic, ECRIN is organising a virtual event for International Clinical Trials Day (ICTD) on May 20th, 2021. ICTD 2021 will bring together stakeholders from across Europe and the globe to discuss the growing interest in platform trials from best practices to challenges in the European context. ICTD is open to research organisations, clinical research professionals, patient organisations, regulatory and ethics bodies, funders and industry. Platform trials, sometimes known as adaptive platform trials, allow a multitude of different treatment options (arms) to be compared with a single control (arm). They enable ineffective arms to be stopped after an interim analysis. To date, they have been used principally in the field of oncology and more recently infectious diseases. They represent the clinical approach selected by the European Commission to find a treatment for COVID-19. This new trial format raises many questions, changes our approach to conducting clinical trials and testing for appropriate treatments.
DARQA & RQA: European QA Symposium 2021 ‘The Future of Quality: What’s keeping you awake at night?’
The European QA Symposium 2021, a collaboration between DARQA and RQA, is an innovative new event designed to meet the needs of QA professionals in the life sciences, medicines, medical devices, and food/feed sectors. The programme has been developed to reflect regulatory changes, the changing nature of regulatory inspection and auditing, and the evolving structure and needs of industry. As such, the event will be delivered online, direct to the homes and workplaces of QA professionals. The event will run over one and a half days, using multiple streams, varied session formats and leading experts to offer a varied programme to suit a European audience. In addition, the event will offer opportunities for delegates to meet with exhibitors, network with industry peers, and chat with friends, colleagues and new acquaintances. With online social activity to cement those relationships.
PROFILES & NKI-AVL: Hoe patiëntgegenereerde data bijdragen aan de kwaliteit van zorg
Het verzamelen en evalueren van PROM’s en PREM’s bij mensen met kanker heeft de oncologie al veel gebracht. Tegelijk belast je patiënten met vragenlijsten en het dragen van wearables. Hoe vind je de balans?
Tijdens het live webinar ‘PROM’s, PREM’s en wearables’ zullen onderzoekers en zorgprofessionals ons meenemen in de meerwaarde en ontwikkelingen van het gebruik van patiëntgegenereerde data voor verbetering van de oncologische zorg.
In de plenaire sessies worden deelnemers bijgepraat over ontwikkelingen in methoden van dataverzameling en hoe we de patiënt daar het beste bij betrekken, aanpak van landelijke cohortstudies, nieuwe inzichten in mechanismen, en speciale doelgroepen. In de breakout sessies kunnen deelnemers in kleinere groepen met de sprekers en elkaar in gesprek over het betreffende onderwerp.
QPS: Human Radiolabeled Mass Balance (hAME) Studies for Regulatory Submission Part I: A Comprehensive Overview and Practical Guide
NWO Life2021
Life is a unique, inspiring, annual national congress covering all disciplines and scale levels in the Dutch Life Sciences, from femtometre to kilometre, from cell to planet. Life2021 is the second edition and will be held online.
PedCRIN: Practical points to consider for neonatal trials – An introduction to the PedCRIN neonatal tools.
These webinars are addressed to researchers and medical professionals interested in conducting paediatric clinical research but are also open to patient associations, patient advocates and expert patients. Registration is mandatory and free of charge.