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The long term goal is for the results of projects supported by this announcement to provide healthcare providers and decision-makers with the scientific evidence to implement effective programs that will:. Broader outcomes expected from this RFA across participating countries include:.

Announcement

Research projects should include a focus on one or more of the four components that are crucial for the prevention and control of high blood pressure, namely prevention, awareness, treatment and maintenance:. Programmes proposed can be new or linked to existing programmes. Innovative approaches, including those that draw on successful local experience and those that lend themselves to adaptation to other environments, will be encouraged through this funding mechanism.

Examples of innovative approaches include the use of electronic and cellular information and communication technologies, the involvement of industry and non-governmental organizations in health or other sectors, the participation of community workers and community leaders. Applications in response to this announcement may utilize a variety of approaches such as experimental and quasi-experimental study designs, mixed methods studies, comparative case studies, economic and mathematical modeling, and combined approaches.

Examples of relevant proposals include:.

Given the implementation focus of this RFA , the following types of studies will not be considered for funding:. This approach does not discount the singular benefits of each of these types of innovation alone, but rather highlights the powerful synergies that can be realized by aligning all three to address a single challenge. Call for research proposals.

Home Funding Calls for proposals Hypertension Call for proposal. EMA held a three-month consultation in on implementing the transparency rules. Over 80 different individuals and organisations submitted more than 1, comments:. Skip to main content. Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation.

Principles

Human regulatory Overview Research and development Marketing authorisation Post-authorisation Herbal products. Clinical Trial Regulation. The Regulation will require: consistent rules for conducting clinical trials throughout the EU; information on the authorisation, conduct and results of each clinical trial carried out in the EU to be publicly available.

Key benefits of the Regulation.


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Harmonised electronic submission and assessment process for clinical trials conducted in multiple Member States Improved collaboration, information-sharing and decision-making between and within Member States Increased transparency of information on clinical trials Highest standards of safety for all participants in EU clinical trials. The Clinical Trials Information System.

The Clinical Trial Journey

Sponsor workspace A secure workspace will assist clinical trial sponsors in preparing and compiling data to submit to the system for assessment by Member States. It will allow sponsors to: search and access clinical trials ; compile clinical trial application dossiers for new and updated trials; cross-reference to product documents in other clinical trials ; supervise their own clinical trials and check progress; receive alerts and notifications for ongoing trials; record clinical trial results; upload documents for clinical trial application form submission; respond to requests for information and view deadlines; manage users and user roles.

Authority workspace A secure workspace will support the activities of Member States and the European Commission in overseeing clinical trials. It will allow Member States to: view application dossiers; manage tasks related to the assessment of clinical trials ; collaborate within and between Member States; receive alerts and notifications for ongoing trials; download documents submitted by clinical trial sponsors; record inspections of sites and clinical trials. Public website Through the website, members of the public can access detailed information on all clinical trials conducted in the EU, in all official EU languages.

The website will provide the following features: overview of clinical trial statistics; advanced search; download data and reports; site updates and announcements. Testing and key bug fixing took place in the spring of Transparency rules.

Support to Nordic clinical research projects

The Clinical Trial Regulation requires all information stored in the database to be publicly available , unless exempted under the Regulation to protect: personal data; commercially confidential information , in particular the marketing-authorisation status of the medicine, unless there is an overriding public interest; confidential communication between Member States in the preparation of their assessment; supervision of clinical trials by Member States.

EMA has added two sets of requirements to the functional specifications for applying the exceptions : features to support making information public; disclosure rules describing the practical implementation of the transparency rules. The EMA Management Board endorsed both documents in Revision of section 6 of the 'Functional specifications for the EU portal and EU database to be audited' setting out features to support making information public Appendix, on disclosure rules, to the 'Functional specifications for the EU portal and EU database to be audited'.

Public consultations. European Commission consultations In preparation for the implementation of the Regulation, the European Commission published on 1 June the following guidance documents for public consultation until 31 August Risk proportionate approaches in clinical trials Summary of Clinical Trial Results for laypersons Definition of investigational medicinal products and use of auxiliary medicinal products Ethical considerations for clinical trials on medicinal products conducted with minor For more information, see European Commission: Clinical trials - Major developments. A total of 47 individuals and organisations submitted more than comments: Draft functional specifications for the EU portal and EU database to be audited Overview of comments received on 'Draft functional specifications for the EU portal and EU database to be audited' EMA held a three-month consultation in on implementing the transparency rules.

Related EU legislation. External links. Revision of the clinical trials directive. How useful was this page?

Call for proposal | GACD

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