As a direct result of the outbreak of the Coronavirus disease (COVID-19) and due to circumstances beyond our control, LS Academy has decided to postpone the Nordic ePharma Day 2020 in Copenhagen to 27 October 2020.
Live Evidence of the Ongoing Systemic Transformation in Clinical Trials
We live in extraordinary times for Clinical Trials conduction and Products Development.
Evolutions in technology, regulations and processes bring along challenges and opportunities for all the parties involved: patients and caregivers, health centres and institutions, healthcare professionals, regulators, sponsors, vendors and contract research organizations (CROs).
As we progressively shift away from treatment towards prevention, from sickness towards wellness, the tech industry is gaining ground, getting closer to patients (and patient’s data). How should pharma react? Competing or joining up?
While the shorter-term benefits of digitalisation are gradually becoming tangible, the long-term ambitions look into transforming the entire clinical trials operating model.
During the 6th Nordic ePharma Day conference 2020, we will focus our attention on the following topics:
- How the Digital Transformation in the Nordic countries will ensure a better patient recruitment?
- What solutions and strategies are now in place to implement new tools and speed up the processes avoiding delays in research?
- How pharma manages oversight (Key Opinion Leaders, CRO selection and contracting, special study designs)?
- Patient involvement: ethical hurdles, practical examples, patient recruitment, study results interpretation/discussion, authorship. Have Patients accessible information on ongoing clinical trials in an easy-to-understand language?
- How to approach the Digital Transformation: Personalised medicine, E-health, digital biomarkers?
- How to manage the new inspection mood? Update on typical IT focus areas and deviations seen during Good Clinical Practice inspections considering the impact of digitalization, artificial intelligence and General Data Protection Regulation
- What is the value of Real-World-Data (RWD) and Real-World Evidence (RWE), and why are they needed? What is the approach in Pragmatic Trials?
- What are ePatient Reported Outcomes (PRO) solutions/requirements? Clinical Development collaboration with patients especially regarding PROs (Quality of Life, RWE, Pharmacovigilance, Adverse Events)
The event is designed for professionals involved in clinical trials design, conduction and management, pharmacovigilance, quality, clinical development and management of pharmaceutical products.
This event will be a key opportunity to network and learn from knowledgeable speakers and experts in the field – experts in these hot topics from the Nordic area perspective.
We hope you find these topics as interesting and enticing as we do. The future is here. We need to appropriately shape it in order to provide enhanced solutions for patients’ better health and quality of life.
Scientific BoardSimona Sgarbi, Senior Real World Evidence Lead at Lundbeck
Rasmus Hogreffe, Head of Virtual Clinical Trials at LEO Innovation Lab
Who should attend?Representatives of Pharmaceutical and Biotechnology companies, Clinical Research Organizations, Academic centers, Hospital Centers, and Clinical Technology companies. Especially Clinical Research Professionals, belonging to the following departments: Clinical Research and Development, Quality Assurance, Regulatory, Pharmacovigilance, Clinical Operations, Statistics and Data Management, Information Technology, Market Access
For sponsorship opportunities, please contact firstname.lastname@example.org
27 Ottobre 2020
Abstract available soon
85% of clinical trials fail to retain enough patients, with the average dropout rate across all clinical trials at around 30% - primarily due to patient access and convenience.
In this session, Dr. Michelle Longmire will present two recent case studies highlighting how decentralized trials throughout the trial process can positively impact trial success and data quality.
Advanced MRI and PET imaging protocols can be used in MAD and phase 2 studies to get early signals, with high precision, of structural and functional efficacy on an organ level. PET imaging can also be used to increase understanding of receptor location and occupancy. Antaros Medical have a number of examples of how these techniques have guided continued drug development. Currently we are working with 6 of the 15 biggest pharma companies in the world.
The eClinical system has been fairly well developed in Norway over the last years, but still there is a long way to go.
A public platform is available, managed and developed by the Norwegian Health Society.
From a patient perspective, one have to admit it is working fairly well to have all information readily available, easy to achieve, on one single platform, but whether its fully updated or not is another question. When most of the health care personnel doing their best to make it work, it is sad to experience that there are doctors, clinics and others in the health care system, not updating nor using the database to the extent they should, consequently it is not as good as it should be.
In this session a Patient perspective is probably worthwhile listening to?
More and more studies are replacing paper with electronic capture of patient reported outcomes (ePROs). When evaluating ePRO solutions, it is critical to consider not only fit with your protocol, but also level of control you can have over implementing the solution and integrating the ePRO results with other clinical data captured at sites in your EDC solution. This presentation will provide practical advice for adopting and engaging patients with an ePRO solution. Topics covered will range from considerations for evaluating and implementing an ePRO solution for onsite or remote data collection to working with validated instrument providers to using the results as part study submission.
The session will cover how we are getting ready for the Clinical Trials Regulation in DK and EU, but also how we are preparing for new kind of trials e.g. complex trial designs and decentralised clinical trials.
The presentation will focus on the specific challenges in relation to use of Artificial Intelligence for processing of personal data in clinical trials in the Nordic Countries (with special focus on Denmark) and how to comply with the requirements in the General Data Protection Regulation (GDPR) and associated national legislation in this context. The design of the training environment and the use of the algorithm behind the AI afterward are essential for a compliant solution which at the same time deduces the risk for non-compliance with the GDPR (including potential high fines and bad publicity).
Research sites continually strive to improve patient recruitment and engagement practices for clinical trials in an effort to provide sponsors with the critical data they need to bring new medications to market safely. In addition, it is an ongoing challenge to retain the number of patients needed to successfully complete and validate the integrity of the study. While the industry continues to search for new solutions that simplify the process and reduce the burden on patients, there is a gap between available solutions and the adoption of those solutions by sites. The prevalent questions are: how long it will take for the majority of sites to adopt new solutions, and what is holding them back?
In an effort to better understand the obstacles to industry-wide adoption, practical examples will be presented to discover the most prominent challenges in conducting trials, site awareness of decentralized clinical trials (DCTs), the alignment between the two preceding points, and the level of education available on telemedicine solutions.
The emergence of advanced technology in the life science industry are promising significant gains in trial efficiencies, collaboration and quality. However, the questions of when and how to integrate new technology must be answered by each organization before the first steps can be taken. This presentation will provide an overview of strategic considerations relevant for organizations embarking on the digital transformation journey. It will include concreate examples of use of digital technologies in Clinical and discuss the benefits and potential challenges to be expected as the industry moves toward transformational digitalization.
Sede della Conferenza
- Hotel Amager (at 3,9 km)
At your arrival you will find our Staff at the Welcome Desk to greet and make you feel welcome and as comfortable as possible, providing direction and all information about the meeting, seating, refreshments.
Coffee breaks and networking lunch will provide a pleasant moment of refreshment and an opportunity for you to network with your industry peers. Special care about the food quality, in particular to your dietary needs or preferences, from menus of local products and flavors to vegetarian dishes.
All our conference facilities are safe, healthy, comfortable, aesthetically-pleasing, and accessible. They are able to accommodate the specific space and equipment needs of the conference. Equipped for audio/visual, Free Wi-Fi to allow everyone to connect with just one click.
All the necessary information for the Conference is provided. The environment is important to us and that's why we try to make this meeting an experience of environmental sustainability.
Seat at the conference, copy of presentations of Speakers who allow the distribution, informative literature for the day, networking lunch, coffee break, organisational office assistance, certificate of attendance.