European Medicines Agency updated the page Clinical Trials Information System (CTIS): online modular training program on October 28, 2022, by adding new versions for the below documents in Module 13 – Clinical study reports submissions:
- Quick guide: Clinical Study Reports submission (v1.1): Updated by providing information on the process to request the Marketing Authorisation Holder (MAH) admin role in CTIS. Users can request the MAH admin role by raising a service desk ticket to CTIS and by attaching the affiliation letter signed by a representative of the MAH/Marketing Authorisation (MAA) to the ticket. MAH admin users, once appointed by EMA admin after validating the affiliation letter can then assign roles of CTIS Submitter or Viewer to other CTIS users.
- FAQs: Clinical Study Reports submission (v1.1): The questions and answers that are updated in this version are –
- Section 4.2: Details of the CSR-related tasks (view, create, edit, submit, update, and withdraw a CSR) that a MAH admin can perform were added.
- Section 4.3: Information on the process to request the MAH admin role in CTIS has been added.
On June 14, 2022, the following update was posted on the EU PAS, News section.
A list of metadata describing real-world data sources and studies has been published on the EMA website, to help pharmaceutical companies and researchers to identify and use such data when investigating the use, safety and effectiveness of medicines.
Real-world data are observational data stored in repositories such electronic health records and disease registries. Making use of these data sources can improve the evidence available to support benefit-risk decisions and facilitate getting better medicines to patients.
This metadata list will feed into two future EU catalogues on real-world data sources and studies:
Setting up a catalogue of data sources and enhancing the catalogue of studies aims to improve transparency with regard to observational studies, enhanced discoverability of studies and data sources, and contribute to increasing the ability to judge the evidentiary value of studies when used to investigate the use, safety and effectiveness of medicinal products. It also helps regulators, researchers and pharmaceutical companies identify studies and data sources suitable to address research questions, based on the so-called ‘FAIR’ (findable, accessible, interoperable and reusable) data principles.
On January 07, 2022, The European Network of Centres in Pharmacoepidemiology and Pharmacovigilance (ENCePP) updated the materials from the Plenary webinar. A report of the November 18, 2021 Plenary webinar and slides describing key aspects of the webinar have been added to the ENCePP website. This webinar provides a brief summary on the current data quality framework for EU PAS Register and ENCePP Resources database. It also includes the results of a survey conducted for the same purpose. Additionally, it focuses on the goals and future prospects for the EU PAS register and ENCePP database.
Additional details can be found here.
European Commission updated regarding, ‘Commission Implementing Regulation (EU) 2021/2078 of 26 November 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the European Database on Medical Devices (Eudamed)‘ posted in the Official Journal of the European Union, on November 30, 2021:
The commission presents eleven articles that explain in detail regarding setting up, accessibility, functional rules, maintaining and managing Eudamed along with different definitions that apply to this regulation. It is mentioned in Article 2 that Eudamed would provide access to authorized users via ‘a restricted website’ and for non-identified users via ‘a public website’.
According to Article 3, to gain access to the restricted website a natural person needs to create an account on the Commission authentication service from where the Commission would register the competent authorities and the authorities responsible for the notified bodies and grant access to the first natural person on their behalf. For other entities to be registered in Eudamed a natural person acting on behalf of the prospective actor shall submit an actor registration request, via the restricted website which would then be approved by the national competent authority.
It is also mentioned in Article 9, that the Commission would provide a website for testing and training to the respective actor website. It would be mandatory for the actor to make at least one successful attempt of data submission using the testing website. The Commission also clarified that the data entered in the testing website would be considered fictitious and would not be available for the public. Concerned actors would be notified in advance via Eudamed of any changes and the period of availability on the testing website.
According to article 12, this regulation will come into force on the twentieth day following its publication in the Official Journal of the European Union and would directly be applicable in all Member States.
For more information, please click here.
The European Network of Centres in Pharmacoepidemiology and Pharmacovigilance (ENCePP) will hold its virtual annual plenary meeting on 18 November 2021. Registration is open to ENCePP Partners (centres and networks) until 26 October 2021.
The event is for ENCePP Partners only, registration from other individuals will not be accepted.
Along with other objectives of the meet, following are the transparency objectives to be discussed:
- To update on the work programme of the HMA-EMA Big Data Task Force and discuss the interface with ENCePP activities. Topics for discussion include the creation of curricula in Data Science, Pharmacoepidemiology and Biostatistics, the upgrading of the EU PAS Register and ENCePP Resources Database, an update on the Real-World Interrogation Network in the European Union (DARWIN EU) and the pilots for data analytics with EMA committees
- To discuss the result of the surveys and agree on the amendments needed for the metadata and functionalities of the EU PAS Register and ENCePP Resources Database
The WebEx joining instructions will be sent to those ENCePP members who have registered via the registration form.
Related documents: 1. Registration Form 2. Meeting agenda
Additional details can be found here.