Events

CTIS is the business tool of the EU Clinical Trials Regulation (Regulation (EU) No 536/2014) and it acts as a single entry point for clinical trial authorisation and supervision in the European Economic Area.

This bitesize talk on CTIS provides an opportunity for sponsors to learn about the Modifications that can be made to a clinical trial application in Clinical Trials Information System (CTIS). Sponsors will also have opportunity to ask questions during the event.

The event is open to all sponsor organisations, including pharmaceutical companies, contract research organisations, small and medium-sized enterprises (SMEs) and academic organisations. EMA cannot provide attendees certificates of attendance for this event.

To be better prepared for this event, sponsors are encouraged to consult the CTIS training and support materials, including the CTIS Sponsor Handbook and the online modular training programme focusing on Module 05 (Manage a clinical trial through CTIS) and Module 10 (Create, submit and withdraw a clinical trial).

The aim of this event is to identify any gaps and opportunities for standards concerning modern nanoparticle-based formulations which can be filled by the European Pharmacopoeia (Ph. Eur.), notably by setting common quality standards across Europe and beyond. This has particular relevance in the context of the COVID-19 pandemic.

Wilt u meer weten over wetenschappelijk onderzoek met medische gegevens en lichaamsmateriaal? Woon dan deze online informatieve bijeenkomst bij.

In 2022, the annual WEON conference will be organized at the Radboudumc in Nijmegen, the Netherlands, on June 9-10. The theme of WEON 2022 is ‘The art of epidemiology’, as it may be considered a real art how to deal with various methodological challenges to answer epidemiological research questions. We also aim to connect epidemiology to actual art!

Er zijn steeds meer data beschikbaar, ook in de huisartsenzorg. Hoe maken we bijvoorbeeld beter gebruik van onze HIS-gegevens en kunnen we daar nog wat aan verbeteren? En voordat we op grotere schaal gebruik kunnen maken van deze data: met welke methodologische uitdagingen gaat analyse van deze data gepaard? Deze en andere vragen komen aan bod tijdens de NHG-Wetenschapsdag. Het Nederlands Huisartsen Genootschap (NHG) en de afdeling Public Health van het Leids Universitait Medisch Centrum (LUMC) organiseren deze dag. Het thema is dit jaar ‘Proactieve huisartsenzorg, gebaseerd op data’. Volg inspirerende lezingen, workshops op het gebied van methodologie, open science en leiderschap en presentaties van wetenschappelijk onderzoek. Ook is er volop ruimte voor discussie en voor de vertaling naar de (toekomstige) praktijk van alledag.

This webinar will take its starting point in the training module “Scientific advice for advanced therapy medicinal products (ATMPs): what and when to ask” that can be accessed through our free self-paced online course: ADVANCE Online course on ATMPs Development. In the webinar the scope of Scientific Advice for ATMPs will be introduced and there will be a Q&A covering the three areas of advice: quality, non-clinical and clinical development.

he motto of this FELASA Congress is COMMUNICATION. This central theme will lead through various content streams: communication between animals, between animals and humans, between fellow researchers, between trainers and trainees, between laboratory Animal Science specialists at all levels and the Society. This congress will give you the chance to learn new things, refine your knowledge and to share your experience in all fields of laboratory animal sciences. At FELASA 2022 you can visit the largest commercial exhibition and enjoy the luxury of a face-to-face discussion with the most knowledgeable commercial representatives who will bring the latest updates in animal care products and research equipment.

The aims of EuroGCT’s first one-day workshop on sharing best practice in public engagement and communicating about gene and cell therapy will be:

> To facilitate the sharing of best practice amongst the EuroGCT partnership.
> To support EuroGCT partners in their professional development so that they can then deliver training/innovative public engagement initiatives within their own localities.
> To foster a network of public engagement professionals amongst the partnership.
> To collectively review the project’s communication activities to date and plan for next steps.
> To plan for future capacity-building workshops, including identifying objectives, topics, potential host organisations, and forming a planning committee.

Registration by 30 April.

The famous physicist Stephen Hawking recognised that “our future is a race between the growing power of our technology and the wisdom with which we use it”. The remarkable advances in the fields of artificial intelligence (AI) and machine learning (ML) over the past few years have attracted considerable attention – and fuelled fears. This year’s SCTO Symposium takes a closer look at this topic from various perspectives. We will use presenters’ contributions and practical national and international examples to take a closer look at the following questions:

> To what extent is the use of AI and ML in clinical research already a reality?
> How can the use of AI and ML benefit clinical research? What kind of clinical research is needed to validate its use?
> What are the opportunities, challenges, and risks of these new approaches?
> With every new technology, the question of regulation inevitably arises. How much regulation is needed, and what (new) ethical questions need to be answered?
> How do key Swiss stakeholders in clinical research currently address these new technological advances and how are they preparing for the future?

January 2022 marked the ten year anniversary of the emergence of the first draft of the General Data Protection Regulation (GDPR). A decade later, and almost four years after the GDPR’s entry into application, the EDPS believes it is time to reflect on the functioning and efficiency of the Regulation. This is why, on 16 and 17 June 2022, the EDPS will host a conference in Brussels bringing together global stakeholders from the digital regulatory sphere to reflect on and discuss current approaches to enforcement models.

The formal presentations will focus on two issues. The first relates to compliance with and implementation of the ICNIRP 2020 Radiofrequency Guidelines. This is an issue that ICNIRP has received many questions about, and although ‘compliance’ itself is not within the remit of ICNIRP, we have tried to put together some presentations that will help those working through such issues. The second relates to ultraviolet radiation, and what the current science says about harm associated with exposure to it. This will consider effects of UV-A/B on the skin and lens of the eye, as well as address the question of whether germicidal UV-C techniques may pose a risk to those exposed to it.

The founding organisations, the International Science Council’s Committee on Data (CODATA) and World Data System (WDS), the Research Data Alliance (RDA), and the local hosts announce that International Data Week 2021 will be postponed to 20-23 June 2022 for the main conference. Associated events will take place in the period 18-26 June 2022. The conference will be a hybrid format with both in-person and virtual participation.

The ECRD is recognised globally as the largest, patient-led rare disease policy event in which collaborative dialogue, learning and conversation takes place, forming the groundwork to shape goal-driven rare disease policies and allow for important and innovative discussions on a national and an international level to take place. Leading, inspiring and engaging all stakeholders to take action, the Conference is an unrivalled opportunity to network and exchange invaluable knowledge with over 1500 stakeholders in the rare disease community – patient advocates, policy makers, researchers, clinicians, healthcare professionals, healthcare industry representatives, academics, payers, regulators and Member State representatives. This 11th edition follows a pivotal two-year Rare 2030 Foresight Study, supported by the European Parliament and European Commission, that guided a large-scale and multi-stakeholder reflection on rare disease policy in Europe through 2030. The concluding recommendation of Rare2030 was the need for a new European policy framework on rare diseases with measurable and actionable goals. Current actions at Member State level alone, or legislative changes in specific areas are not enough. We need a new European collective strategy for rare diseases to bring Member States’ commitment to rare diseases under a common umbrella and mark a step forward in the post-COVID world. This ECRD will be a critical opportunity for all stakeholders to consider how to transform this exhaustive review of the strategy on rare diseases into a proposal of concrete actions ultimately creating the ecosystem required to address the unmet needs and persisting inequalities across Europe.

Join CDISC and the Trial Master File (TMF) Reference Model Group as we bring a new dimension to the clinical research community by broadening our offerings to support clinical trial operations and facilitate operations at research sites.

The Dutch Bioinformatics & Systems Biology conference 2022 (BioSB 2022) discusses the latest developments in bioinformatics, systems and computational biology and interrelated disciplines, and their wide-ranging applications in life sciences & health, agriculture, food & nutrition.

edere dag worden in de klinische praktijk grote hoeveelheden gezondheidsdata gegenereerd: beeldvorming, pathologie, laboratoriumuitslagen, behandelgegevens, bijwerkingen, en follow-up gegevens zoals moment van overlijden en terugkeer van ziekte. Deze gegevens kunnen dankzij vergaande digitalisering steeds eenvoudiger ontsloten en gebruikt worden voor onderzoek. Het onderzoek met deze zogenaamde ‘real world data’ wordt in toenemende mate gepropageerd als aanvulling op, of alternatief voor tijdrovende en dure klinische (gerandomiseerde) studies. Tijdens dit BOOG symposium zoomen we in op de waarde van real world data, en het daaruit voortvloeiende real world evidence (RWE), voor het optimaliseren van behandeling van patiënten met borstkanker.

Jointly organised by the project team of the NSRI and Netherlands Research Integrity Network (NRIN). This symposium is open to all researchers with an interest in research integrity, as well as relevant stakeholders within the research system. This will be a hybrid event, taking place at Pakhuis de Zwijger (Amsterdam) with live streaming. If Covid-19 circumstances demand, the symposium will be held online only as a live streamed event. The event will be held in English and presentations will be recorded, with videos being made available through NSRI and NRIN’s YouTube Channels after the event.