Events

Op de IvD-Platformmiddag wordt een workshop ‘Horen, zien en praten’ gegeven en is er een gastpresentatie over intercollegiaal auditeren. Deze workshop is geschikt voor iedereen die weleens iemand moet (of zou moeten) aanspreken op het niet volgen van afgesproken procedures. Hoe kunnen we dit samen op een waarderende manier onderzoeken en verbeteren?

Step into the new era of clinical trials: Future-proof your strategies to ensure clinical trial succes. Decentralized Trials, Digital Health, Patient Centricity, Real World Evidence, Diversity and Sustainability and Post-Pandemic Learnings.

The patient has a unique expertise: “being a patient.” But often patients are insufficiently trained to share their experiences and insights in the care process and to translate them into an improved quality of life as well as into more patient-oriented policy insights and system improvements. By educating and guiding patients, their expertise can be systematically incorporated into the care process and the ultimate goal can be achieved: improving the quality of care, increasing efficiency and reducing costs. This webinar is for anyone interested in learning what a patient expert is, and what added value patients experts can bring to each of the different stakeholders within healthcare in Belgium

The 2022 International QA Conference will be geared towards workshop and discussion sessions, where delegates can really network with and learn from one another. Take an active part in discussions or sit back and listen to what your colleagues have to say. This conference we want delegates to re:connect with the industry and each other.

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The Clinical Trials Information System (CTIS) is the single-entry point for clinical trials authorisation and supervision in the European Economic Area (EEA). This includes an integrated clinical trial application dossier, covering clinical trial applications submitted to EU/EEA Member States, including submission to national competent authorities (NCAs) and ethics committees (ECs), and registration of the clinical trial in a public register. CTIS provides harmonised and simplified end-to-end electronic application procedures over the lifecycle of clinical trials across the EU / EEA. The focus of this virtual information day 9 months after the CTIS launch is to share some practical advice regarding transitioning clinical trials from the Clinical Trials Directive (2001/20/EC) to the Clinical Trial Regulation (536/2014) as well as best practices on user management. The event will feature first insights from assessments of clinical trial applications and system metrics on usage of CTIS. It will also outline the importance of understanding timelines in CTIS, as will upcoming training opportunities and events. There will be time for questions and answers.

Gene therapy could enable patients to live without the need for ongoing treatments or the burden of daily disease management. How are we turning this promise into reality? Join us for the latest insights from local and international experts discussing the current and future treatment modalities, how to address technical or regulatory challenges and build clinical evidence.

ECRIN will host its 2nd CTU Day from 10-13h on 2 December 2022. The event is open to members of ECRIN national partner networks. The program is in the process of finalisation but this years event will include feedback on the use of CTIS for multinational trials.

This walk-in clinic on CTIS functionalities provides an opportunity for sponsors to receive practical about the Clinical Trials Information System by asking questions to CTIS experts in real-time. The CTIS experts will address all the questions related to system functionalities. Questions about the interpretation of the Clinical Trial Regulation and /or national processes are out of the scope of this event. The event is open to all sponsor organisations, including pharmaceutical companies, contract research organisations, small and medium-sized enterprises (SMEs) and academic organisations

You are invited to a multi-stakeholder workshop where participants will discuss requirements for Digital Health Technologies in clinical trials, including the development of digital endpoints. What are current challenges related to the use of Digital Health Technologies and what the opportunities for optimising evidence generation for qualification and regulatory pathways? Join the conversation. Building on the great momentum in Europe, with initiatives such as ACT-EU or the EMA Regulatory Science Research needs, and advances in IMI projects such as IDEA-FAST or Mobilise-D, EFPIA is organising a multi-stakeholder workshop on the use of Digital Health Technologies (DHTs) in drug development, with a focus on digital data including digital endpoints. This workshop will offer an opportunity to discuss how to optimise DHTs development, evidence generation for validation/qualification, and regulatory pathways, and to clarify some of the challenges faced so far. To be held virtually on 12-13 December 2022, the workshop seeks to build a roadmap for enabling the use of DHTs in drug development in Europe and beyond. It will be designed with plenary sessions and interactive breakout sessions to integrate views and expectations of the various stakeholders, and to share learnings and solutions.

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 Annual Safety Report that is submitted via CTIS. Sponsors will also have opportunity to ask questions on this CTIS topic during the event. To be better prepared for this event, sponsors are encouraged to consult the CTIS training and support materials, focusing on the e-learning course of Module 19 (How to create and submit an ASR and respond to related RFIs) of the online modular training programme, as well as the CTIS Structured data forms on Annual Safety Report.

The Annual Meeting of the Society for Clinical Trials is a multidisciplinary program with broad participation. The Meeting brings together the clinical trials community from academia, the pharmaceutical and device industries, government agencies, medical groups and centers and clinical research entities.