Category: Belgium

European Commission provided an update regarding the Progressive roll-out of the In Vitro Diagnostic Medical Devices Regulation on December 20, 2021:

The update mentions that the ‘In Vitro Diagnostic (IVD) Medical Devices Regulation’ can now be progressively rolled out, after its adoption by the European Parliament and the Council to ensure there is no shortage of essential medical devices and will come into force from May 26, 2022, as planned.

Keeping into consideration the high paucity of the notified bodies, it also notifies about the amendment to the IVD Regulation of 2017, that has changed the dates of application of some requirements for certain essential medical devices.

• Higher risk devices (class D): New requirements will apply from May 2025
• Lower risk devices (class C): The date of application is extended until May 2026
• Lower risk class devices (class B and A sterile): Application starts in May 2027
• In-house devices: Delayed by two years until May 2024

It also mentions that the transitional periods will come to an end in May 2028, if the unavailability of an equivalent device on the market is proved by the health institutions. However, no change is proposed for ‘new-devices’ or CE-marked devices that do not require notified body involvement, for these devices the IVD Regulation will apply from May 26, 2022.

For more information, please click here.

European Medicines Agency (EMA) updated the pages Clinical Trials Information System: training and support and Clinical Trials Information System (CTIS): online modular training programme on December 16, 2021, by adding the below documents:

1. Clinical Trial Information System (CTIS) structured data form – Annual Safety Report (ASR): This document provides guidance on the data fields Sponsors will have to fill in CTIS when creating an ASR and also contains screenshots of different sections of the system (CTIS software version 0.18.35.3).
2. Clinical Trial Information System (CTIS) structured data form – Request for information (RFI): This document provides guidance on the data fields Sponsors will have to fill in CTIS when responding to an RFI and also contains screenshots of different sections of the system (CTIS software version 0.18.35.3).
3. Clinical Trial Information System (CTIS) list values: This document contains the terms of all the lists present in the CTIS structured data forms for an initial application (IN), additional MSC application, substantial modification, and non-substantial modification applications, notifications, ASR, and RFIs.
4. Step-by-step guide: How to manage a CT – Module 05: It provides a stepwise guidance to create notifications, respond to RFIs, respond to request for opinion regarding corrective measures and to submit trail results and results summary for lay person.
5. Quick guide: How to manage a CT – Module 05: It provides information on the four system functionalities i.e. notifications, RFIs raised, results summary and summary for lay person along with CTIS insights.

Also an updated version of FAQs: How to create, submit and withdraw a Clinical Trial Application – Module 10 was uploaded with an addition of Section 7-Roles and Permission.

European Medicines Agency updated about the upcoming event Clinical Trials Information System sponsor user training program over the What’s New Section on December 16, 2021:

The event page notifies about EMA’s plan to conduct six different virtual training courses as part of the training program for sponsor users and the dates on which these courses will be conducted throughout the year 2022 to support sponsor user preparedness, guide on submitting a clinical trial application, and managing the life cycle of a clinical trial in the European Union (EU) and European Economic Area (EEA).

The first sponsor user training course will be conducted from January 24, 2022, to January 27, 2022, for the clinical trial sponsors. The event page also provides a list of components that must be completed before participating in the program along with the topics that will be covered during the virtual live program.

A registration link has been provided for interested sponsor users to participate in the first sponsor user training course.

For more information, please click here.

European Medicines Agency updated the page Clinical trials information system (CTIS): online modular training programme, on December 14, 2021, by adding the new versions of the below documents:

1. Step-by-step guide: Create, submit and withdraw a clinical trial application and nonsubstantial modifications – Module 10: It explains the different types of clinical trial applications (CTA), non-substantial modifications and steps required for creating, submitting and withdrawing it.
2. Step-by-step guide: How to respond to requests for information received during the evaluation of a Clinical Trial Application – Module 11: It provides stepwise guidance for sponsor users to view and access right for information (RFI) raised by member states concerned (MSC) and to create, modify an existing CTA and submit a response.
3. FAQs: Union Controls in CTIS – Module 21: It provides answers to general questions regarding Union Controls, its reports, plans/programmes, roles and permission.
4. Step-by-step guide: Union Controls in CTIS – Module 21: It provides stepwise guidance to create and share plans/programmes for Union Controls and also to create, submit, view, download, update and withdraw Union Control reports.
5. Quick guide: Introduction to CTIS for public users – Module 22: It provides an overview of the CTIS public website and stepwise guidance for public users to search, view, and download information of a clinical trial (CT). It also provides steps to view the Union Control reports.
6. FAQs: Introduction to CTIS for public users – Module 22: It provides answers to questions regarding CTIS public website, its different search functionalities, view and download CTs and CTAs information, and Union Controls.

Also, an updated version of the Guide to CTIS training material catalogue was uploaded with the addition of ‘Module 24: Business Intelligence Reporting’ in the list of modules and general CTIS information.

European Medicines Agency updated the page Clinical trials information system (CTIS): training and support, on December 13, 2021, by adding the below document:

Getting started with CTIS: Sponsor Quick guide- It provides step-wise guidance for the sponsors to select one of the user management approaches i.e. organization-centric approach or trial-centric approach and complete registrations required in both the approaches for the submission of clinical trial application.

For more information, please click here.

The sixth issue of CTIS Highlights was published on December 13, 2021. It provides certain preparatory steps to be taken by the sponsor before using CTIS, discusses the upcoming events and training material to be updated in early 2022.

It reminds all future CTIS users without an EMA account to register for an EMA account as soon as possible. It also reminds the sponsor organizations opting for the organization-centric approach to register in EMA’s organization management system (OMS) along with their first high-level administrator, the sponsor administrator, via EMA account management before using CTIS, if not registered yet. The clinical trial sites that routinely participate in clinical trials are advised to register in OMS to facilitate submission of clinical trial application (CTA).

It briefly discusses EMA’s plan to host ‘CTIS Talks’, an upcoming event explaining CTIS key functionality areas. In this event, participants will get an opportunity to ask questions to CTIS experts. More details about the event will be provided shortly.

The newsletter also notifies that along with the 20 CTIS training modules that are currently available, revisions of the existing modules and new modules including introduction to CTIS for public users, management of union controls by European Commission, and transition of clinical trials from directive to regulation will be published in the upcoming year of 2022.

It mentions that the respondents of the survey provided in the previously issued newsletter regarding self-assessment and interest in accessing the training environment will be contacted directly in December 2021. It also discusses, in brief, the sponsor end-user training that will start next year and the recently updated version of the CTIS Sponsor Handbook.

European Medicines Agency updated the page Clinical trials information system (CTIS): online modular training programme, on December 10, 2021, by adding the below document in CTIS Training Module 03 (User access management):

Quick guide: User access management – It explains in brief the significance of the OMS portal and steps to access the guidance documents available on the portal. It also includes step-by-step guidance for searching an organization, creating a new organization and updating an existing organization with screenshots and CTIS insights.

For more information, please click here.

European Medicines Agency (EMA) updated the page Clinical Trials Information System: training and support, on December 02, 2021, by adding a new version of the CTIS – Sponsor handbook (v2.0).

The 2.0 version of CTIS – Sponsor handbook included the following updates:

1. Section 3.2.1-Updated the process of registration in organization management service (OMS)
2. Section 4.5- Added new links for CTIS user personas and principles for sponsor organization modeling in CTIS
3. Section 5- Updated information for product management in CTIS
4. Section 6- Updated information for the transition from directive to regulation
5. Section 7.1.3- Added a new section ‘Data fields and documents specifications’ that includes all the data fields required in CTIS along with the character limits. It also provides the characteristics of documents to be uploaded on CTIS
6. Section 8.1- Updated information for suspected unexpected serious adverse reactions (SUSARs) reporting
7. Section 10.4- Added a new section ‘CTIS training environment for user training and organization preparedness’ which describes the CTIS sandbox, its purpose, and the two secure workspaces (authority and sponsor) intended for its access. It also describes, in brief, the three waves and the timeline in which access to the CTIS Sandbox will be provided

Along with the above updates some editorial changes were made across the document.

For more information, please click here.

EMA updated the Webinar for small and medium-sized enterprises (SMEs) and academia on the Clinical Trials Regulation and the Clinical Trials Information System (CTIS) event page by adding a list of documents, on November 25, 2021.

The following documents are PowerPoint presentations that are to be presented in the Webinar that will be held on November 29, 2021:

1. Clinical Trial Regulation 536/2014: Objectives, key changes, and transitional arrangements: It describes in detail the difference between the existing and upcoming legislative. It also explains the processes involved in clinical trial results (CTR) submission and authorization, the process of transition from the pre-clinical trial per Directive 2001/20/EC (CTD) to CTR, CTD to CTR, and submission of application of transition.
2. European Organisation for Research and Treatment of Cancer (EORTC): Stakeholders’ experience with the Clinical Trial Regulation No. 536/2014 implementation: It explains the main points of impact highlighting the timelines for initial, substantial modification, a summary of CT results and results for layperson submissions, and updates in the study documentation (new harmonized CV template, protocol, informed consent form, lay summary for protocol and results). It also presents, in brief, the key compliance considerations, enlists different types of stakeholders, transparency rules, and user management approaches.
3. Medical Faculty and Heidelberg University Hospital: Stakeholders’ experience with the Clinical Trial Regulation No. 536/2014 implementation: It provides the key points to remember for the user management, accessibility to CTIS, transition period, timelines, and processes.
4. Transgene: Stakeholders’ experience with the Clinical Trial Regulation No. 536/2014 implementation: It provides a three-step approach for CTR implementation preparation i.e., identify, inform and prepare, and implement. It also confers some of the experienced comments and challenges faced in CTR adoption along with advices for CTR implementation and preparation.
5.  Access and user management, roles, and permissions: It provides information on self-registration, default CTIS roles, different approaches of user management, pros and cons of organization-centric and clinical trial-centric approaches, roles and permissions required, and user management hierarchy.
6. CTIS explained with user personas and organisation models: It describes the core personas of CTIS and organization modelling with its key principles.
7. High-level overview of CTIS, joint controllership arrangement (JCA), and publication rules: It describes the high-level functionalities explaining the authority and sponsor workspaces, the open and secure accesses, and roles of sponsor and member states. It also explains the publication rules in CTIS, deferral eligibility for category 1 trials, data that will be published, and things that will not be made public regardless of its category.
8. The process for submitting clinical trials information in the European Union-European Economic Area (EU-EEA): It provides timelines and due dates in CTIS, information on the required database before initial submission, submission of CTA, evaluation timeline, intended corrective measure timeline, substantial and non-substantial modifications, update for initial submission, application for re-submission, and trial and recruitment periods.
9. Safety reporting in CTIS: It provides an overview of reporting safety data in CTIS and briefs the legal framework of Regulation (EU) 536/2014.
10. Overview of guidance and training available for sponsors: It provides the CTIS catalog of all the training materials along with its current status. It also explains in short regarding the CTIS Sandbox.

A tab for live broadcast has already been uploaded by EMA on the event page. Video recording of the webinar will be made available after the event.

For more information, please click here.