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#11. EU Clinical Trials Regulation: EMA Steers Away from ...

AMSTERDAM—The European Medicines Agency's (EMA) proposal regarding the specifications of the European Union (EU) clinical trials database can jeopardise the ...

#12. Clinical Trials Europe - Informa Connect

Europe's leading clinical trials conference focusing on partnerships, outsourcing, operations and technology is now 100% virtual. 2-4 November 2021, Nice, ...

#13. EU Trials Tracker — Who's not sharing clinical trial results?

Sponsor name Trials on EUCTR Trials due to report results % Reported Tri... Novartis 1491 851 99.9% 329 GlaxoSmithKline 1165 636 100.0% 386 Merck Sharp & Dohme (MSD) 822 458 100.0% 176

#14. Compliance with requirement to report results on the EU ...

Objectives To ascertain compliance rates with the European Commission's requirement that all trials on the EU Clinical Trials Register ...

#15. An ESMO-EORTC position paper on the EU clinical trials ...

The European Society for Medical Oncology (ESMO) and the European Organisation for Research and Treatment of Cancer (EORTC) welcome the adoption of the ...

#16. What is the Clinical Trials Regulation? - Biomapas

The EU CTR is the new Regulation that govers all interventional clinical trials using human medicinal products. By implementing this Clinical Trials ...

#17. EDCTP: Home

Funding for clinical research |drugs, vaccines, microbicides, ... clinical trials and clinical research activities conducted by European-African consortia.

#18. EU Clinical Trial Regulation – Defining the change - Accenture

The Clinical Trial Regulation (Regulation (EU) No 536/2014) aims to standardize the assessment and supervision processes, improve co-ordination ...

#19. How to Prepare For New EU Clinical Trials Regulation | PPD Inc

A: The EU CTR promotes transparency of clinical trial data, allowing public access to information — except for sensitive and commercially confidential data ( ...

#20. EU launches clinical trials transformation initiative | RAPS

The EU has just kicked off a new initiative meant to transform how clinical trials are initiated and run to promote clinical research in the ...

#21. EU Clinical Trial Regulation to Take Effect on 31 January 2022

The European Commission has announced that the Clinical Trials Regulation, already enacted in 2014, will take effect on 31 January 2022.

#22. Sharing of clinical trials results to increase transparency

Patients can look for clinical trials information in the portal www.clinicaltrialsregister.eu. This Register is the public repository of information contained ...

#23. Coming Soon: The New EU Clinical Trial Regulation - Lexology

The Clinical Trial Regulation introduced a new regime for EU clinical trials. It harmonises the rules for conducting clinical trials in the EU ...

#24. Accelerating Clinical Trials in the EU (ACT EU) initiative launch

The new ACT EU initiative seeks to transform how clinical trials are initiated, designed and run in the European Union.

#25. Clinical Trials Facilitation and Coordination Group - Heads of ...

Benchmarking of European Medicines Agencies · EU Network Pharmacovigilance Oversight Group ... Clinical Trials Facilitation and Coordination Group ( CTFG ) ...

#26. Consequences of Brexit for Clinical Trials in Europe

Unfortunately, solely UK-based CROs can no longer conduct clinical trials in the EU on behalf of sponsors from the US or other non-European ...

#27. EudraCT | Research and Innovation | Imperial College London

EudraCT (European Union Drug Regulating Authorities Clinical Trials) is the European Clinical Trials Database of all CTIMPs with at least one site in the ...

#28. Redundant trials can be prevented, if ... - BMC Medical Ethics

Article 4 of the EU Clinical Trials Regulation stipulates that a trial application shall be subject to both ethical and scientific review. The ...

#29. European clinical trials | ECRAN Project

ECRAN – European Communication on Research Awareness Needs – for communicating key-messages to citizens, patients, healthcare professionals, etc... about ...

#30. EU Clinical Trials Register - Google Sites

The European Union Clinical Trials Register provides access to trial protocols and summary trial results information for interventional clinical trials ...

#31. Ethical review of patient safety and public health in EU clinical ...

Purpose: The study considers the ethical review of the European Union (EU) clinical trials (CTs) legislation, namely the Clinical Trials Regulation (CTR) ...

#32. EU Clinical Trial Regulation: what you need to know

The regulation's aim is to create a landscape that is “favourable to conducting clinical trials in the EU, with the highest standards of safety ...

#33. Clinical trials - BEUC

They do so to contribute to scientific progress for the benefit of society. Every year approximately 4,000 clinical trials are authorised in the European Union.

#34. Europe launches initiative to transform clinical trials

Regulatory bodies in the European Union have launched an initiative to develop the region as a focal point for clinical research and to ...

#35. The EU Clinical Trials Regulation: key priorities, purposes and ...

The replacement of the European Union (EU) Clinical. Trials Directive by the new Clinical Trials Regulation (CTR), which entered into force on 16 June 2014 ...

#36. Registration of clinical trials for investigational medicinal ...

For trials involving both UK and EU sites a record in the EU Clinical Trials Register will exist (other than adult Phase 1 studies).

#37. EU Clinical Trial Portal and EU Database Declared Functional ...

In line with Article 82(3) of the EU Clinical Trials Regulation (i.e., Regulation (EU) No 536/2014 of 16 April 2014; the CTR), the Decision ...

#38. EU legal representative clinical trials - Lumis International

EU Legal Representative ... Every sponsor conducting a clinical trial in the European Union without a registered office within the territory of the European ...

#39. Clinical Trials of Investigational Medicinal Products (CTIMPS)

Legislation sets out how drug trials are approved, conducted, monitored and ... EU Advanced Therapy Medicinal Products (ATMPs) Regulation ...

#40. EMA proposes EU clinical trial reforms - PMLiVE

The European Commission (EC), European Medicines Agency (EMA) and EU regulators from The Heads of Medicines Agencies have set out proposals ...

#41. EU Clinical Trial Regulation: Get Ready. Set. Go! - DIA Global ...

The European Union Clinical Trial Regulation 536/2014 (EU-CTR) aims to standardize and harmonize the conduct and management of interventional clinical ...

#42. EU clinical trial regulation: public consultation

Unknown author (‎2012)‎. EU clinical trial regulation: public consultation. WHO Drug Information 2012; 26(‎4)‎ : 384-385 ...

#43. Europe: An EU-wide call for clinical trial transparency - Global ...

The Regulation: The EU's Clinical Trial Regulation will come into force in all member states on 31 January 2022, and contains enhanced ...

#44. EU Clinical Trial Register | re3data.org

The EU Clinical Trials Register is part of EudraPharm, which is the community database of authorised medicinal products. The website provides ...

#45. Six top tips to prepare for the new EU Clinical Trial Regulation

For the first. 12 months after EU-CTR launches, sponsors can choose to submit CTA requests for new trials under the current. EU Clinical Trials Directive 2001/ ...

#46. EU Clinical Trial Regulation: What, When, Who, Why, How ...

The CTR will replace the European Clinical Trials Directive (2001/20/EC). The regulation harmonizes the assessment and supervision processes for ...

#47. How to participate in a Clinical Trial in Portugal and in ... - RNEC

The EUCTR allows you to search for information on: - Interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area ...

#48. Differences in clinical trial conduct in US and EU ...

US, believe the quality of EU clinical trials ... sponsor clinical staff based in Europe be- ... each aspect of clinical trial conduct that we.

#49. Europe preps for the launch of its new clinical trials database ...

Once it's live, CTIS will offer a single clinical trial application dossier, covering clinical trial applications submitted to EU/EEA member states (and to ...

#50. Clinical Trial Approval in Europe - EUPATI Toolbox

In Europe clinical trial approval is granted by a regulatory authority and requires favourable opinion by a Research Ethics Committee (REC). The CT Directive ...

#51. New EU Clinical Trials System Could Support Patient ...

The EU research-based pharma industry is exploring partnerships to develop an app that would extract data from the new Clinical Trial ...

#52. Clinical trials: launch of a new Information System | EU ...

The application will bring substantial changes to the authorisation and supervision of human research on medicinal products. Stella Kyriakides, ...

#53. The new European clinical trials regulation

binding impact across the EU, avoiding the fragmentation and vagaries of interpretation that have plagued Directive 2001/20/EC. Page 8. Definition: Clinical ...

#54. EudraCT - Wikipedia

EudraCT is the European Clinical Trials Database of all clinical trials of investigational medicinal products with at least one site in the European Union ...

#55. European Authorized Representative for Clinical Trials - Emergo

The role of the Authorized Representative in EU clinical trials · documentation to be submitted to Local Authorities, including Clinical Study Protocol, ...

#56. Changes to EU Clinical Trial Regulations | Resources - MESM

The introduction of the EU-CTR aims to restore the EU's competitiveness in clinical research by reducing administrative requirements and improving efficiency ...

#57. Clinical trials regulations - UKRI

Key facts about the regulations In 2001 the European Union (EU) adopted the EU Clinical Trials Directive (2001/20/EC) as a framework for ...

#58. Update Disclosure Policy for EU Clinical Trial Regulation ...

The European Medicines Agency (EMA) recently announced the European Union (EU) Portal, a database for obtaining a clinical trial authorization, ...

#59. Clinical trials | NHS Confederation

A new EU Clinical Trials Regulation was agreed in 2014, introducing a raft of changes to the existing, controversial, EU Clinical Trials ...

#60. Moving Your Clinical Trials To Europe - PSI CRO

What do you know about transitioning clinical trials to Europe? Moving your trial to the EU is no small task. With regulatory agencies, varying approval ...

#61. Preparing for new EU clinical trials regulation in partnership ...

The new Clinical Trials Regulation was first adopted by the European Medicines Agency (EMA) in 2014 and will come into effect in January 2022, ...

#62. EudraCT- Clinical Trials Register - Paul-Ehrlich-Institut

The European Clinical Trials Register includes the results of clinical trials. It doesn't include information on non-interventional clinical ...

#63. Opportunities and Challenges for Reforming the EU Clinical ...

Building the European clinical research environment ... The introduction of the Clinical Trials Direc- ... tion of EU Clinical Trials on medicinal prod-.

#64. Poor implementation of the EU clinical trial regulation is a ...

The principle of pragmatism in clinical trials has been broadly recognised as a way to close the gap between research and practice.

#65. EU Clinical Trials Regulation to apply from December 2021

On 12 June 2020, the management board of the European Medicines Agency (EMA) announced December 2021 as the date of entry into application of the EU ...

#66. EU Clinical Trials Regulation: The Application Process

EU Clinical Trials Regulation: The Application Process. Juliette L. Kirk. Article. One of the major changes introduced by the European Union (EU) regulation ...

#67. White Paper The EU Clinical Trials Regulation - CROMSOURCE

Currently all clinical trials performed in the European Union must be conducted in accordance with the EU Clinical Trials Directive (EU-CTD)1.

#68. The EU Clinical Trials Directive: 3 years on - The Lancet

The EU clinical trials directive came into force in May, 2004, with the aim of simplifying the trial application process and providing a ...

#69. EU clinical trials portal to go live in early 2022 - Mills & Reeve

A three year transition period will allow sponsors of EU clinical research time to transfer to using the new system, although EU member states ...

#70. Half of European clinical trials have not complied with EU ...

#71. Cross-Border Access to Clinical Trials in the EU - Frontiers

Based on the EU's principle on freedom of movement, participation in a clinical trial abroad is theoretically possible. While there is no ...

#72. New Clinical Trial Rules in the EU: A Practical Overview of the ...

With the upcoming application of the new EU Clinical Trials Regulation ('CTR'), the conduct of clinical trials in the European Union ('EU') ...

#73. What will the upcoming Clinical Trial Regulation mean for the ...

In recent weeks, the European Medicines Agency (EMA) has confirmed that the clinical trial EU Portal and Database, the key component of the ...

#74. EU Clinical Trials Register - BASG

clinical trials on medicinal products conducted outside the EU / EEA that are linked to European paediatric-medicinal product development. The information ...

#75. The New European Union Regulation for Clinical Trials - ACRP

Clinical trials can be defined as investigations made in humans to discover or verify the positive and/or negative effects (effectiveness ...

#76. 4 Implications of the EU's New Clinical Trial Regulation

The new regulation harmonizes clinical trial requirements throughout the EU by establishing a new Clinical Trials Information System—a ...

#77. What Are the Documents Required for Clinical Trial ...

Biotech and pharma companies planning clinical trials in Europe will have to submit a clinical trial application (CTA) to the national ...

#78. Clinical trials in the post Brexit Europe - PharmaLex

The EU rules for clinical trials, which are set out in EU Directives including 2001/20/EC 1 may be no longer be applicable to the UK and this is concerning for ...

#79. Trends and Variation in Data Quality on the EU Clinical Trials ...

Abstract. The EU Clinical Trial Register (EUCTR) is a public facing portal containing information on trials of medicinal products conducted ...

#80. Deciphering the EU clinical trials regulation - Nature

In April of 2014, the European Parliament and Council adopted the new Clinical Trial Regulation (EU) no. 536/2014 (ref. 2), with the hope of ...

#81. Redundant trials can be prevented, if the EU clinical trial ...

Keywords: Clinical trials, EU clinical trials regulation, Research ethics, Research ethics committees, Research redundancy, Systematic review, Trial ...

#82. Clinical Trials in Europe

Director of The Cancer Research UK Clinical Trials Unit ... European Clinical Trial Groups ... Decrease in numbers of academic sponsored clinical trials.

#83. EU Calls For Results Of All EU-based Clinical Trials To Be ...

The European Commission and European Union medicines regulatory agencies sent an open letter to all sponsors of EU-based clinical trials to remind them of.

#84. New implementation date of the Clinical trial regulation

The European Medicines Agency (EMA) has just announced that the implementation date of the EU Regulation governing clinical trials (CTR) and ...

#85. Transparency and the European Medicines Agency

Guided by public health interests, the European Medicines Agency has set new standards for clinical trial data transparency by adopting a ...

#86. New EU (536/2014) clinical trial regulation set to attract more ...

The way clinical trials are conducted in the European Union (EU) will undergo a major change when (EU) No 536/2014 comes into effect in ...

#87. EU Clinical Trials Regulation - Sense About Science

Establish a new publicly accessible EU clinical trials register, to be set up and run by the European Medicines Agency. • Require that all trials used in ...

#88. the clinical trial process: impending changes in the regulatory ...

Ensuring compliance with regulatory requirements at local, national and EU level is a key element in the design of clinical trials in every EU country.

#89. Clinical Trials after the end of the Brexit transition period

After the end of the transition period, however, EU rules on clinical trials will no longer, by default, apply to the UK.

#90. European Union: EU Clinical Trials Regulation: The ... - Mondaq

European Union: EU Clinical Trials Regulation: The Clinical Trials Information System Expected To Go-live By December 2021 According To The EMA.

#91. Clinical research in Europe: Who do we do all that for?

This, together with economic challenges in health care systems, lead to the implementation of the European Union Clinical Trials Directive (CTD) in 2004.

#92. EudraCT | Clinical trials conduted in the EU need to be ...

In June 2019, the EC, the EMA and the HMA co-signed a letter reminding all sponsors of clinical trials conducted in the EU of their ...

#93. The EU Clinical Trial Regulation: Virtual EU Filings ...

The webinar covers the impending changes coming with the EU Parliament passage of the EU Clinical Trial Regulation, which will affect all trials ...

#94. ENCePP considerations of non interventional studies

gathers available expertise and research experience across Europe and ... legislation (in the transposition of the EU Clinical Trials.

#95. The implementation of the Clinical Trial Regulation ...

While the Regulation (EU) No 536/2014 was adopted back in 2014, its application in the European Union depends on the full functionality of ...