Events

The new EU Clinical Trials Regulation (CTR) was published in 2014, became applicable in all member states Jan 31 2022 and from Jan 31 2023 is mandatory for all new EU clinical trials (CTs). The EU CTR harmonises clinical trial applications in Europe and aims to deliver greater public transparency around CTs in Europe and create a favourable research environment in Europe by reducing administrative requirements on CTAs and streamlining workflows. The changes introduced in the CTR are broad, and require industry CT sponsors, CROs and Regulatory Agencies to approach CT applications differently, including submission via the new Clinical Trial Information System (CTIS). CTIS is a single online portal through which clinical trial sponsors and other organisations involved in running clinical trials will submit data related to a trial and post-trial results. The session will begin with a brief overview of the changes introduced in the Clinical Trials Regulation, followed by sharing of implementation experiences of Industry CT sponsors, CROs & Agencies. The audience will then have the opportunity to exchange experiences around implementation and use of the CTIS and pose questions to the speaker panel to ensure readiness for implementation in January.

The European Health Summit is an annual event organised by the European Business Summits. As with all of our events, the focus is on bringing together businesses, policymakers, and academia to debate the key healthcare issues in Europe and beyond.

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.

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

Highlights and topics of the event will include:
> The impact of biosimilar competition in Europe: with IQVIA presenting
the key findings from their 2022 report (for the 2021 report, see https://www.iqvia.com/library/white-papers/the-impact-of-biosimilar-competition-in-europe-2021).

> Interchangeability of biosimilars, with sessions dedicated to:
– The available evidence and regulatory guidance on interchangeability (including the recent joint EMA-HMA statement), as well as the different policies implemented by national authorities related to switching and substitution of biosimilars;
– Interchangeability in clinical practice, with a focus on oncology; including learnings and best-practices, as well as perspectives from academia, healthcare providers and patients.

>Untapping the full potential of biosimilars, a panel discussion with different stakeholders (including national authorities, industry, healthcare providers, patient organisations) providing insights on how to best prepare for upcoming biologicals losing exclusivity.

A more detailed agenda, together with registration and connection details will
follow. In-person participation will be upon invitation only, for speakers and
Member States’ authorities.

Waar staan we met het Europese voorstel voor betere gegevensuitwisseling in de zorg, de EHDS? Wat gaat de impact zijn van de EHDS voor de Nederlandse actoren in de zorgmarkt? Die vragen staan centraal in de EHDS-Meetup op 14 december. Doe mee.

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.

Medical research continues to rapidly evolve with the rising capacity of high throughput technologies and the digital revolution. Personalised medicine has particularly benefited and grown with this data-driven approach, and has seen a rising number of complex, cross-disciplinary projects requiring new methodologies, new technologies and new research infrastructure services. The PERMIT project was designed to develop a set of methodological recommendations to support investigators, evaluators, peer-reviewers, regulators and other stakeholders involved in designing, funding, conducting, publishing and validating PM research.

Eye tracking is a powerful method to study the human mind and behavior. This course will allow you to explore key concepts in eye tracking research and help you integrate it in your study. The course is divided into two components: (1) a conceptual framework to help you make better decisions when planning and executing a study, allowing you to turn eye tracking data into valuable insights; (2) a practical introduction to the challenges and trade-offs you will encounter during a study, helping you to establish a set of “good practices” that you can easily transfer to your research.

From January 2023 onwards all clinical trial applications, including phase 1 trials, need to be submitted according to the new Clinical Trial Regulation (CTR). As is often the case, a change in procedures and regulations is a cause for concern. Therefore, in this meeting, all stakeholders are brought together and given the opportunity to express their perceived challenges and opportunities as we move into this new legislative framework. Ample time will be available for a panel discussion in which all participants are invited to participate.

In this 7th edition of the Conference you will have the opportunity to gain a better understanding on the new European regulations on medical devices. Additional regulations (implementing acts) of the Medical Device Regulation and new guidance are issued frequently adding to the complexity. It is important to keep up-to-date with the fast evolving compliance scene. This event addresses to all those involved in the medical device field worldwide, such as Medical Device Companies, R&D and QA personnel, CEOs / CROs / CRAs, Regulatory Affairs Specialists, Research facility managers, Pharmaceutical Company representatives and Start-Up Companies. In conjunction with EAAR (European Association of Authorized Representatives), our excellent panel of experienced professionals in this field will once again ensure a conference of noteworthy quality.

DIA Europe 2023 is designed to drive insights into action by connecting key policy discussions to real-world knowledge that you need for your everyday job. Your participation will accelerate your growth and your organization’s performance in the drug development ecosystem.

Join global healthcare leaders as they convene at ISPOR 2023, the leading global conference for Health Economics and Outcomes Research (HEOR), May 7-10, for discussion and dissemination of the latest trends in healthcare. This must-attend event provides you with dedicated opportunities to network with your peers, HEOR experts, and thought leaders and to discuss with a global audience how we establish, incentivize, and share value sustainable for health systems, patients, and technology developers.

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.

Knowledge for growth is Europe’s finest life sciences conference. For the first time the event will take place in Antwerp. The conference features an exciting programme providing vital insight into the global life sciences’ landscape, one-to-one partnering, a trade fair and more!

The DIA 2023 Global Annual Meeting invites industry, regulatory government, academics, and patients to network, problem-solve, and discuss global and local challenges facing the life sciences community. Hosted in Boston, DIA 2023 will amplify different perspectives while highlighting expertise across the globe to reimagine current processes that better enhance health and well-being.