Clinical Trial Regulation ema europa eu

Clinical Trial Regulation Ema Europa Eu-Free PDF

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The Clinical Trial CT Regulation what is new,Regulation EU No. Before May 2004 Directive 2001 20 EC 536 2014 CT,CT Directive Regulation. Different processes and Published on, requirements for clinical trial First step to harmonise 27 May 2014. authorisations in each processes and requirements, Member States for clinical trial authorisations Application 6 months after. confirmation published in the OJ, resulted in delays and Implementation of full functionality of EU portal.
complications detrimental to 1 May 2004 and EU database. effective conduct of clinical, trials in the EU Concerns expressed soon after Transitional arrangements. its implementation,The Clinical Trial Regulation what is new. CT Directive versus CT Regulation,Implemented in national laws Directly applicable. Objectives of new CTR,To protect the rights safety dignity and well. being of subjects and the reliability and,robustness of the data generated in the CT.
To foster innovation and simplify the clinical,trial application process in particular for. multistate trials,To increase transparency keeping the. balance between protecting public health and,fostering the innovation capacity of European. medical research while recognising the,legitimate economic interests of the. Overall objective Make EU attractive for,Scope of Regulation EU No 536 2014.
Interventional clinical trials with medicinal products for human use. NEW category of low intervention clinical trials with adapted requirements. o The investigational medicinal products IMP are authorised and used according. to the terms of MA, o If the IMP is not used in accordance with the terms of the MA that use is. supported by published scientific evidence on S E, o Minimal additional risk or burden to the safety of the subjects compared to. normal clinical practice,Not covered,Non interventional trials. Trials without medicinal products e g devices surgery etc. Key changes introduced by the CT Regulation, Single e submission to all MSCs via an EU portal accessible to MS NCAs and Ethics. Committees,Harmonised dossier Annex I to the Regulation.
Coordinated assessment between Reporting MS and MS Concerned. One single decision per Member State Concerned,Tacit decision for the MS single decision. Introducing a risk adapted approach by applying less stringent rules to those trials. conducted with medicines which are already authorised and which pose only minimal. risk compared to normal clinical practice,Key changes introduced by the CT Regulation. Reinforcing supervision of clinical trials by introducing Union Controls in Member. States to ensure that the Regulation is properly supervised and enforced. Provisions concerning clinical trials conducted outside the EU but referred to in a. clinical trial application within the EU which will have to comply with regulatory. requirements that are at least equivalent to those applicable in the EU. New provisions for Informed Consent, Increasing transparency as regards clinical trials and their outcomes. Summary of key changes from CT Directive to CT Regulation. As is Directive 2001 20 EudraCT To be CT Regulation The EU portal and database. Multiple submissions for one trial 1 Single e submission to all MSCs harmonized. submission per each MSC no harmonized dossier for one trial e submission of structured data. dossier e submission limited to structured data and documents by MSCs. and paper based submission,Double submission within a Member State. Concerned MSC to National Competent,Authorities NCAs and to Ethics Committees.
Individual assessment by each MSC with no IT Joint assessment for Part I facilitated by collaboration. collaboration tool available tools, No single MSC decision NCA ECs Single MSC decision. Burden to NCAs in uploading information in the,Distribution of the burden among users. Limited EudraCT data availability to the public,structured data from the application CTA and. summary of results View all CT related information. MSC member state concerned,EMA role The EU portal and database. Regulation EU No 536 2014 Art 80 EU Portal, The Agency shall in collaboration with the Member States and.
the Commission set up and maintain a portal at Union level as. a single entry point for the submission of data and. information relating to clinical trials in accordance with this. Regulation The EU European Union Portal shall be technically. advanced and user friendly so as to avoid unnecessary work. Data and information submitted through the EU portal shall be. stored in the EU Database,Regulation EU No 536 2014 Art 81 EU Database. The Agency shall in collaboration with the Member States and. the Commission set up and maintain a EU database at Union. level The Agency shall be considered to be the controller of the. EU database and shall be responsible for avoiding unnecessary. duplication between the EU database and the EudraCT and. Eudravigilance databases,Implementation of the CT Regulation EMA role. Single EU entry point for clinical trial applications e dossier. Provides workspace with collaboration tools and capabilities for. AND coordinated assessment between Member State Concerned. CTIS SYSTEM,One single decision per Member State Concerned. Art 80 to 84 Enables supervision at EU level including inspections. Provides publicly available information, REPORTING Upgrade of EudraVigilance clinical trial module for the. electronic reporting of SUSARs, Art 40 to 44 Delivers an Annual safety reports ASRs repository.
EUDRACT Delivers transition between the current and new systems. Collaborative working,The EMA is working collaboratively. COMMISSION,STAKEHOLDERS,MEMBER STATES Sponsors,ETHICS CROs. COMMITEES HCPs,Patient Representatives,systems developed to implement the regulation. CTIS Actors and activities in the CTIS system,Submit application initial AMS. Submission Submission of Union Notification of willingness to be. and SMs Address request for,of CSR Control Reports RMS part I Decision on RMS.
information, Update of Clinical Trial Applicant Commission Submission of. Submission of requests,requests for, information re non substantial of a MA information. information,modifications,Notification of the,Submission final. validation,validation initial,outcome initial additional. additional MS,Submit notifications or Substantial Modification.
Start of trial,First visit first subject Submission final. Submission final AR,conclusion to,Part 1 and,End of recruitment Member Part I and Part II. End of trial in each MS All Sponsors,Final single decision notification. Temporary halt restart, Serious Breach Unexpected Submission Assessment of Communication disagreement. event urgent safety measure ASRs ASRs to part 1 assessment. Inspection from third country,inspectorate Communication on.
General Search and view CT,implementation of corrective. public information,Submission of clinical study measures. result summary and lay person Maintenance Amend Submission Inspection. summary publication Information,EU portal and database high level system overview. Public website,Entry site Public search, Display news announcements and scheduled Search for keywords and filter results. downtimes Find public clinical trials via the same portal as pro. View publicly available statistics on clinical trials active publications medicinal products and articles. registered in the EU Database,Access in all official languages of the European.
Public clinical trial data,Access detailed clinical trial information. Download trial information and documents,View and download predefined reports. The Clinical Trial Regulation what is new 2 Scope of Regulation EU No 536 2014 3 Scope Interventional clinical trials with medicinal products for human use NEW category of low intervention clinical trials with adapted requirements o The investigational medicinal products IMP are authorised and used according to the terms of MA o If the IMP is not used in accordance with the

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