EU Clinical Trials Regulation Regulation EU 536/2014

Size: px
Start display at page:

Download "EU Clinical Trials Regulation Regulation EU 536/2014"

Transcription

1 EU Clinical Trials Regulation Regulation EU 536/2014 María Jesús Zafra Director, QA & Compliance Table of contents Introduction Timelines and main changes Highlights 5 Impact on company processes 6 Conclusions Page 2 1

2 Introduction A Directive is mandatory, aimed at Member States (MS), which must then be transposed into national legislation (1 directive 28 laws) Clinical Trials Directive (CTD) A Regulation is mandatory and self-executing without need for Member State s transposition (1 law at EU level) => New Clinical Trials Regulation (CTR) Page 3 Introduction EU Directive 2001 (2001/20/EC) Diferent interpretation and application between Member States Submission to each Competent Authority (CA) and Ethics Commitee (EC) Increase cost and administrative burdens Delays for launching multinational trials Page 4 2

3 Introduction Most relevant change to CT legislation since the EU was implemented in 2001 Significant change for submission procedures, transparency, simplification New EC CTR will repeal EU Directive Binding for all Member States Page 5 Introduction 99 Articles 7 Annexes: I. Application dossier for the initial application II. Application dossier for substantial modification III. Safety reporting IV. Content of the summary of the results of the CT V. Content of the summary of the results of the CT for the lay persons VI. Labeling of IMP and auxiliary medicinal products VII. Correlation table with EU CTD Covers the full study life cycle Applies to interventional studies Page 6 3

4 Table of contents Introduction Timelines and main changes Highlights 5 Impact on company processes 6 Conclusions Page 7 Timelines and main changes Publish notice +3m Results on March m Applicable by Dec 2017 (?) Date of publication + 18 months Delayed to Dec 2020 (?) 28 May 2019 Postponed! Ready for auditing at the end of 3Q May Nov May 2016 EU Portal operational (estimated) Earliest date EU CTR applies New CT submission under current Directive ends Old trials must be transferred to EU Regulation EU CTR Official Publication It will apply as from 6 months after the publication of the notice of successful audit Page 8 4

5 Timelines and main changes Main changes Single entry point for all CTs conducted in Europe: EU Portal EU Database Single authorization procedure for all CTs: Faster assessment by all MS One single outcome More transparency for CTs data Lighter regulatory regime for CTs conducted with medicines already authorized and which pose only minimal risk compared to normal practice Recognized co-sponsorship Page 9 Timelines and main changes Main changes Summary of changes: New CTA submission process throughout EMA portal New class of low interventional CTs Transparency requirements Extension of UK serious breach legislation to all 28 EU countries Aligned safety reporting requirements Clarifications to Informed Consent (emergency setting) Clarification of non IMPs (now Auxiliary Medicinal Products) TMF updates (at least 25 years filing) Additional/changed start-up roles and responsibilities in EU Additional notifications during study life cycle Page 10 5

6 Timelines and main changes EU Portal For submission of ALL documents of CT dossier Via of communication between MS and Sponsor Purpose to coordinate multi-national CTs and streamline deadlines and reporting Requests Member States EU Portal Submission and answer to requests Page 11 Sponsor Timelines and main changes EU Database Keeps track of all records and data in CTs conducted in EU Member States Easier access to the information Citizens can access clinical trials information Page 12 6

7 Table of contents Introduction Timelines and main changes Highlights 5 Impact on company processes 6 Conclusions Page 13 Current CTA evaluation procedure (excluding Voluntary Harmonization Procedure) Sponsor MS specific evaluation MS National decision (independent) Submission to each country CA/EC Page 14 7

8 New CTA evaluation procedure Via Portal only Part I: no local country process Part II: review by national EC remains Part I and II can be sequential or in parallel Sponsor PART I (Scientific) 1 Reporting Member State Part I EVALUATION REPORT EU decision Via EU portal PART II (Ethics) Each country Part II MS NATIONAL DECISION Page 15 PART I STUDY SPECIFIC DOCS The concerned MS cooperate in the assessment of scientific, therapeutic and safety aspects PART II COUNTRY/SITE SPECIFIC DOCS The assessment is made by each concerned MS individually and would apply to items such as biological samples, clinical trials agreements, informed consent, recruitment of subjects PART I + PART II Can be reviewed in parallel or alternatively. Part I can be reviewed first followed by part II, depending on the sponsor s preference Page 16 8

9 Review timelines have been established, with a total maximum time of 106 days allowed for the initial submission Advance therapy can take up to 156 days Page 17 Overall timelines: Validation 10 to 25 days (Calendar days) Part I Assessment 45 to 76 days Part II Assessment 45 to 76 days Decision 5 days TOTAL 60 to 106 days Page 18 9

10 Substantial modification timelines: Validation 6 to 21 days (Calendar days) Part I Assessment 38 to 69 days Part II Assessment 38 to 69 days Decision 5 days TOTAL 49 to 95 days Page 19 Notifications via Portal: To notify, WITHIN 15 DAYS, each country of the following: Start of the trial First patient, first visit (FPFV) End of recruitment Last patient, last visit (LPLV) Final end of trial (LPLV, last country) Suspension Temporary halt Early termination Page 20 10

11 Notifications via Portal (cont): Database (within Eudravigilance DB) to notify SUSARs and Annual Safety Reports Detailed SUSARs via Eudravigilance DB within specified timelines Annual Safety Reports via Eudravigilance DB And: These reports are forwarded to the MS All third country inspection reports Page 21 Table of contents Introduction Timelines and main changes Highlights 5 Impact on company processes 6 Conclusions Page 22 11

12 Highlights From potential 28 to just 1 Single application Permitted Full regulatory responsibility unless agreed otherwise Cosponsorship Based on the nature of CT Flexible Monitoring Page 23 Highlights SUSARs reported directly to Eudravigilance Results are public Summaries within 1 year CSR to support MA within 30 days of opinion PENALTIES Transparency Safety reporting Reported by the Sponsor to MS through the EU portal within 7 days Serious breaches Page 24 12

13 Highlights More detailed rules on ICF: Cluster trials: simplified process Use of data generated for future CTs Emergency situations Informed consent Specific provisions for pregnant or breastfeeding women taking part in CTs Page 25 Highlights Safety reporting Streamline reporting based on EU centralized database for safety reporting (no longer required to submit identical information to different bodies and MS) Possibility of submitting a single Annual Safety Report in all the investigational products used in one trial Page 26 13

14 Highlights Areas of concerned: IT effort by EMA to meet deadlines Required national legislation to be adapted to fit the new framework, especially the collaboration between CAs and ECs Compatibility of MS IT systems EC approvals have to be gained nationally but within same timeframe Possible workload of Reporting MS Is it possible to ask for a clock stop when responding to questions? Not clear information about submission documents Page 27 Table of contents Introduction Timelines and main changes Highlights 5 Impact on company processes 6 Conclusions Page 28 14

15 Impact on company processes Preparation: BD awareness Functional team awareness Functional team impact assessment required for evolution of processes, templates, strategy management and resources Transition plan MS difficulties for implementation Plan Management Follow up of country deliverables New metrics Adapt strategy!! Page 29 Impact on company processes Functional team impact assessment required for evolution of processes, templates, strategy management and resources: Business Development Business Units Start-up Units Medical Writing Safety Clinical Operations Units Quality Legal Page 30 15

16 Impact on company processes What is needed: What will we have: New submission process New requirements/ templates New notifications New requirements in terms of maintenance notifications Impact analysis (functional Units) adaptations (SOPs, Working Instructions, Project Plans, Compliance with new notification requirements) Template adaptations (protocol, EU summary for lay persons) Systems adaptation: New notifications Serious breach notifications, assessment and reporting Internal use of Portal and Database Integration with study management Page 31 Impact on company processes At implementation: Transition period: EU CTD & EU CTR to coexist (Sponsor s choice) Assessment based on country local regulation compliance with EU CTR Operational issues Posting of study results at marketing application stage (Sponsor s responsibility most probably) Page 32 16

17 Impact on company processes Hot topics: Changes in process and procedures Development of new capability Needs cross-functional assessment Creation of new roles Teams training Changes and reconfigurations of existing IT systems Simultaneous start in EU changes in expectations of CROs Needs to manage two Quality Systems if EU CTD & EU CTR coexist? EU CTR timelines not defined re-assessment of projects Pricing impact for global trials? For low-interventional trials? Page 33 Impact on company processes Understand the EU CTR and the impact Expertise and good knowledge of how to implement the regulation could be a differentiator: Detailed discussions with clients New customers? Review costs Opportunities: Differentiated response for proposals (RFP) Page 34 17

18 Table of contents Introduction Timelines and main changes Highlights 5 Impact on company processes 6 Conclusions Page 35 Conclusion UE: IT effort from EMA/MS MS effort to adequate national legislation to Part II evaluation Company: EU CTR impacts on company processes Requires knowledge of new regulation and anticipation Requires close follow-up of the implementation Impact on different company functional groups and CTs implementation strategy Requires to review processes, train personal Page 36 18

19 Thank you! Page 37 19

The New EU Clinical Trial Regulation Potential Impacts on Sites

The New EU Clinical Trial Regulation Potential Impacts on Sites The New EU Clinical Trial Regulation Potential Impacts on Sites Angela Papa Associate Director, Clinical Management PPD Pierre-Frédéric Omnes Director, Site Start-Up and Regulatory INC Research Faculty

More information

The New EU Clinical Trials Regulation: The Good, the Bad, the Ugly

The New EU Clinical Trials Regulation: The Good, the Bad, the Ugly A Full-Service International CRO The New EU Clinical Trials Regulation: The Good, the Bad, the Ugly Dr. Martine Dehlinger-Kremer Vice President, Global Medical and Regulatory Affairs The original intent

More information

The EU Clinical Trial Regulation A regulator s perspective

The EU Clinical Trial Regulation A regulator s perspective 5 The EU Clinical Trial A regulator s perspective Author Martyn Ward, Group Manager, Licensing, Medicines and Healthcare products Regulatory Agency (MHRA), UK. Keywords Clinical Trial Directive (the Directive);

More information

Clinical research: where are we with the new (Paediatric) RC trial Regulation

Clinical research: where are we with the new (Paediatric) RC trial Regulation where are we with the new (Paediatric) RC trial Regulation, MD, PhD Ethical Committee DEEP Former member of the PDCO EMA With the aid of Fabio D'Atri European commission and Anabela Marcal of EMA The new

More information

ICRIN Seminar on EU Regulation of Clinical Trials

ICRIN Seminar on EU Regulation of Clinical Trials ICRIN Seminar on EU Regulation of Clinical Trials 12 th March 2013, Dublin J. Michael Morris Director Scientific Affairs IRISH MEDICINES BOARD 28/03/2013 Slide 1 Overview Clinical Trial (CT) legislation

More information

The Clinical Trials Regulation EU No 536/2014: and Phase I trials

The Clinical Trials Regulation EU No 536/2014: and Phase I trials The Clinical Trials Regulation EU No 536/2014: and Phase I trials EUFEMED, Brussels, 20 May 2015 Presented by Fergus Sweeney Head, Inspections and Human Medicines Pharmacovigilance An agency of the European

More information

White Paper The EU Clinical Trials Regulation Main Changes and Challenges

White Paper The EU Clinical Trials Regulation Main Changes and Challenges White Paper The EU Clinical Trials Regulation Main Changes and Challenges Table of Contents 1. Introduction... 3 2. Main Changes and Associated Challenges... 4 2.1 Procedure for Initial Authorisation...

More information

Federal agency for medicines and health products

Federal agency for medicines and health products Federal agency for medicines and health products A critical review of the proposed EU Clinical Trial regulation Walter Janssens Kristof Bonnarens April 2013 CT regulation - general Commission adopted the

More information

The new EU Clinical Trials Regulation How NHS research and patients will benefit

The new EU Clinical Trials Regulation How NHS research and patients will benefit the voice of the NHS in Europe Briefing September 2014 Issue 19 The new EU Clinical Trials Regulation How NHS research and patients will benefit Who should read this briefing? This briefing will be of

More information

The European Clinical Trials Framework Update on the Draft Clinical Trials Regulation

The European Clinical Trials Framework Update on the Draft Clinical Trials Regulation The European Clinical Trials Framework Update on the Draft Clinical Trials Regulation Dr. Ilona Reischl BASG/AGES Austrian Agency for Health and Food Safety GmbH Content - References "Proposal for a Regulation

More information

Clinical trials regulation

Clinical trials regulation Clinical trials regulation The Proposal for a Regulation of the European Parliament and of the Council on Clinical Trials on Medicinal Products for Human Use and Repealing Directive 2001/20/EC an update

More information

The EU portal and database

The EU portal and database The EU portal and database ECPC General Assembly - 20 June 2015 Presented by Laura Pioppo Clinical and Non-clinical Compliance Service An agency of the European Union Table of contents Legal basis CT programme

More information

Clinical trials: from European perspective to National implementation. CTFG / FAMHP / pharma.be. Brussels, 19 November 2010

Clinical trials: from European perspective to National implementation. CTFG / FAMHP / pharma.be. Brussels, 19 November 2010 Clinical trials: from European perspective to National implementation CTFG / FAMHP / pharma.be Brussels, 19 November 2010 Safety in clinical trials: From detection to decision How safety events are captured

More information

EFPIA Principles for the Development of the EU Clinical Trials Portal and Database

EFPIA Principles for the Development of the EU Clinical Trials Portal and Database Position Paper EFPIA Principles for the Development of the EU Clinical Trials Portal and Database Executive summary EFPIA sees the implementation of the Clinical Trials Regulation 1 as an opportunity to

More information

Clinical Trial Data Transparency Environment & Expectations EMA Policy - Clinical Trials Regulation

Clinical Trial Data Transparency Environment & Expectations EMA Policy - Clinical Trials Regulation Clinical Trial Data Transparency Environment & Expectations EMA Policy - Clinical Trials Regulation Joint BBS-EFSPI Seminar, Basel, 13 Nov 2014 Sabine Atzor, Head of EU Regulatory Policies PDR Overview

More information

Serious Breaches. Ian Gravenor. Senior Clinical Project Manager Novo Nordisk Ltd

Serious Breaches. Ian Gravenor. Senior Clinical Project Manager Novo Nordisk Ltd Serious Breaches Ian Gravenor Senior Clinical Project Manager Novo Nordisk Ltd Serious Breaches of GCP or the Trial Protocol Agenda Why report? The legislation MHRA Guidance document Timelines Actions

More information

Regulation of clinical trials with medicinal products: Where are we now?

Regulation of clinical trials with medicinal products: Where are we now? Regulation of clinical trials with medicinal products: Where are we now? Mariantonia Serrano Castro Department of Medicines for Human Use Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)

More information

The new European clinical trials regulation Dr. N.Gökbuget

The new European clinical trials regulation Dr. N.Gökbuget The new European clinical trials regulation Dr. N.Gökbuget Head of Study Center Department of Medicine II and Goethe University Cancer Center Frankfurt, Germany European Leukemia Net: Major Aim to Foster

More information

Response of the German Medical Association

Response of the German Medical Association Response of the German Medical Association to the European Commission proposal for a regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and

More information

Standard Operating Procedures (SOP) for: Reporting of Serious Breaches of GCP or the Trial Protocol sponsored CTIMP s. Lisa Austin, Research Manager

Standard Operating Procedures (SOP) for: Reporting of Serious Breaches of GCP or the Trial Protocol sponsored CTIMP s. Lisa Austin, Research Manager Standard Operating Procedures (SOP) for: Reporting of Serious Breaches of GCP or the Trial Protocol sponsored CTIMP s Author: Lisa Austin, Research Manager Purpose and Objective: To identify and standardise

More information

This is meant to be a narrative rather than a critical summary I have a lot of questions about the proposal but I will look into these separately.

This is meant to be a narrative rather than a critical summary I have a lot of questions about the proposal but I will look into these separately. REVISION OF THE CLINICAL TRIALS DIRECTIVE Proposal for a Regulation of the European Parliament and of the Council on Clinical Trials on Medicinal Products for Human Use, and Repealing Directive 2001/20/EC.

More information

Strong support. Remaining concerns

Strong support. Remaining concerns EORTC opinion on the proposal for an EU Regulation on clinical trials on medicinal products for human use and the 7 th of June ENVI report on this proposal It is clear that the Commission and appointed

More information

The EFGCP Report on The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2012) Sweden

The EFGCP Report on The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2012) Sweden The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe Sweden Question 1: What laws or regulations apply to an application for conducting a clinical trial in Sweden?

More information

The Clinical Trials Directive in the EU: Present and Future Elisabethann Wright, Partner Maurits Lugard, Partner. May 2010

The Clinical Trials Directive in the EU: Present and Future Elisabethann Wright, Partner Maurits Lugard, Partner. May 2010 The Clinical Trials Directive in the EU: Present and Future Elisabethann Wright, Partner Maurits Lugard, Partner May 2010 Background (1) The Clinical Trials Directive 2001/20/EC The intention of this Directive

More information

LEBANESE MINISTRY OF HEALTH DIRECTIVE

LEBANESE MINISTRY OF HEALTH DIRECTIVE LEBANESE MINISTRY OF HEALTH DIRECTIVE LAYING DOWN DETAILED GUIDELINES FOR SPONSORS OF CLINICAL TRIALS March 2012 Field of Application General Considerations Trial s submission Validity of the F-MRI opinion

More information

SETTING UP INTERNATIONAL CLINICAL TRIALS IN EUROPE: THE EORTC EXPERIENCE

SETTING UP INTERNATIONAL CLINICAL TRIALS IN EUROPE: THE EORTC EXPERIENCE SETTING UP INTERNATIONAL CLINICAL TRIALS IN EUROPE: THE EORTC EXPERIENCE Dr. Pharm. Fabienne LAMBERT, PhD Head Regulatory Affairs Unit European Organisation for Research and Treatment of Cancer (EORTC)

More information

EMA Clinical Laboratory Guidance - Key points and Clarifications PAUL STEWART

EMA Clinical Laboratory Guidance - Key points and Clarifications PAUL STEWART EMA Clinical Laboratory Guidance - Key points and Clarifications PAUL STEWART Framework Labs generate data that are used to make decisions on the safety and efficacy of medicinal products; consequently,

More information

STANDARD OPERATING PROCEDURE FOR RESEARCH. 2. Notification of Serious Breaches of Good Clinical Practice or Study Protocol

STANDARD OPERATING PROCEDURE FOR RESEARCH. 2. Notification of Serious Breaches of Good Clinical Practice or Study Protocol Basildon and Thurrock University Hospitals NHS FT Research & Development APPROVED STANDARD OPERATING PROCEDURE FOR RESEARCH 2. Notification of Serious Breaches of Good Clinical Practice or Study Protocol

More information

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL EUROPEAN COMMISSION Brussels, 17.7.2012 COM(2012) 369 final 2012/0192 (COD) Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on clinical trials on medicinal products for human use,

More information

Date : Date of start of procedure: Authorisation/ positive opinion :

Date : Date of start of procedure: Authorisation/ positive opinion : Substantial Amendment Notification Form (Cf. Section 3.7.b of the Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use,

More information

PROCEDURE FOR PREPARING GCP INSPECTIONS REQUESTED BY THE EMEA. GCP Inspectors Working Group

PROCEDURE FOR PREPARING GCP INSPECTIONS REQUESTED BY THE EMEA. GCP Inspectors Working Group European Medicines Agency Inspections London, 20 September 2007 EMEA/INS/GCP/197228/2005 Procedure no.: INS/GCP/2 PROCEDURE FOR PREPARING GCP INSPECTIONS REQUESTED BY THE EMEA GCP Inspectors Working Group

More information

Agence fédérale des médicaments et des produits de santé

Agence fédérale des médicaments et des produits de santé Agence fédérale des médicaments et des produits de santé From Risk Management Plan to Risk Minimization Activities New Royal Decree: Status and General Explanation Role of the Pharmacovigilance Department

More information

EU DIRECTIVE ON GOOD CLINICAL PRACTICE IN CLINICAL TRIALS DH & MHRA BRIEFING NOTE

EU DIRECTIVE ON GOOD CLINICAL PRACTICE IN CLINICAL TRIALS DH & MHRA BRIEFING NOTE EU DIRECTIVE ON GOOD CLINICAL PRACTICE IN CLINICAL TRIALS DH & MHRA BRIEFING NOTE Purpose 1. The Clinical Trials Directive 2001/20/EC heralds certain additional responsibilities for the Medicines and Healthcare

More information

Overview of the EU CTA Regulatory Framework and Future Direction of the EU Clinical Trial Directive. Features

Overview of the EU CTA Regulatory Framework and Future Direction of the EU Clinical Trial Directive. Features 72 Features STEPHAN REYNIER Project Director Voisin Consulting, France Overview of the EU CTA Regulatory Framework and Future Direction of the EU Clinical Trial Directive Over the last few years, the European

More information

Standard Operating Procedure on Training Requirements for staff participating in CTIMPs Sponsored by UCL

Standard Operating Procedure on Training Requirements for staff participating in CTIMPs Sponsored by UCL Page 1 of 10 Standard Operating Procedure on Training Requirements for staff participating in CTIMPs Sponsored by UCL SOP ID Number: Effective Date:01/08/2012 Version Number & Date of Authorisation: V02,

More information

Overview of Key Obligations Under Regulation (EC) No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures (CLP)

Overview of Key Obligations Under Regulation (EC) No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures (CLP) Overview of Key Obligations Under Regulation (EC) No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures (CLP) Summary This document examines the key aspects of the CLP

More information

Biotech Concerto #3. European Clinical Trial Environment

Biotech Concerto #3. European Clinical Trial Environment Biotech Concerto #3 European Clinical Trial Environment December 2008 Index EU Directive EU Approval System European Authority: EMEA The Guidance Documents Route Map Challenges EMEA Organization Chart

More information

Template for essential information to be provided for proposals including clinical trials / studies / investigations

Template for essential information to be provided for proposals including clinical trials / studies / investigations Template for essential information to be provided for proposals including clinical trials / studies / investigations Document history Version 2016callsV1 September 2015 Modifications (compared to previous

More information

European Regulatory Newsletter July - September 2013

European Regulatory Newsletter July - September 2013 European Regulatory Newsletter July - September 2013 Introduction CROMSOURCE is committed to sharing our expertise with our clients and future clients. This reflects the first part of our Advise Agree

More information

COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP)

COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP) European Medicines Agency Veterinary Medicines and Inspections London, 18 May 2006 Doc. Ref. EMEA/CVMP/32995/2006 COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP) GUIDELINE ON THE PROCEDURE FOR

More information

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) European Medicines Agency Pre-authorisation Evaluation of Medicines for Human Use London, 17 July 2006 Doc. Ref. EMEA/419127/05 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON THE PROCEDURE

More information

EFPIA position on Clinical Trials Regulation trialogue

EFPIA position on Clinical Trials Regulation trialogue EFPIA position on Clinical Trials Regulation trialogue As the revision of the Clinical Trial Directive enters the Trialogue phase, it is critical to remember that the key objective of this legislation

More information

The EFGCP Report on The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2011) Russia

The EFGCP Report on The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2011) Russia The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2011) Russia Question 1: What laws or regulations apply to an application for conducting a clinical

More information

Early Phase Clinical Trials: Public Access to the EU Database Repository

Early Phase Clinical Trials: Public Access to the EU Database Repository European CRO Federation Via Lucrezio Caro, 63 00193 Roma, Italy Tel.: +39 06 807 60 72 Fax: +39 06 807 60 85 Email: info@eucrof.eu Internet: www.eucrof.eu Early Phase Clinical Trials: Public Access to

More information

What is necessary to provide good clinical data for a clinical trial?

What is necessary to provide good clinical data for a clinical trial? What is necessary to provide good clinical data for a clinical trial? Alain Barrois, Assistant Clinical Trials Operations Manager #EBMT2015 www.ebmt.org Is this a (typical) clinical trial? 2 Agenda Introduction

More information

Medical Device Directive 2007/47/EC What is New? Are we moving towards Drug Rules?

Medical Device Directive 2007/47/EC What is New? Are we moving towards Drug Rules? Medical Device Directive 2007/47/EC What is New? Are we moving towards Drug Rules? CEMO Congress, Paris, February 3rd, 2011 Dr. Martine Dehlinger-Kremer Vice President Global Regulatory Affairs Agenda

More information

NRA FUNCTION IN CONTROLLING VACCINES IN CLINICAL TRIAL AND MARKETING AUTHORIZATION INDONESIA 2013 DVI MEETING 9 11 APRIL 2013 1

NRA FUNCTION IN CONTROLLING VACCINES IN CLINICAL TRIAL AND MARKETING AUTHORIZATION INDONESIA 2013 DVI MEETING 9 11 APRIL 2013 1 NRA FUNCTION IN CONTROLLING VACCINES IN CLINICAL TRIAL AND MARKETING AUTHORIZATION INDONESIA 2013 DVI MEETING 9 11 APRIL 2013 1 2 The National Agency of Drug and Food Control (NA-DFC) is a non departmental

More information

Questions and Answers to the Annual Safety Report

Questions and Answers to the Annual Safety Report Questions and Answers to the Annual Safety Report Frequently asked questions regarding the Development Safety Update Report (DSUR) Question 1 DSUR Start Stop 1.1 When to start preparing and where to submit

More information

The EFGCP Report on The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2011) Denmark

The EFGCP Report on The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2011) Denmark The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2011) Denmark Question 1: What laws or regulations apply to an application for conducting a clinical

More information

Detailed guidance AEs reporting in clinical trials ( CT-3 ) Stefano Bonato, M.D. Pharmacovigilance Country Head Bayer HealthCare Pharmaceuticals

Detailed guidance AEs reporting in clinical trials ( CT-3 ) Stefano Bonato, M.D. Pharmacovigilance Country Head Bayer HealthCare Pharmaceuticals Detailed guidance AEs reporting in clinical trials ( CT-3 ) Stefano Bonato, M.D. Pharmacovigilance Country Head Bayer HealthCare Pharmaceuticals Pharmacovigilance costs 0.12%-0.22% of hospital admissions

More information

White Paper CLINICAL RESEARCH IN BELGIUM AN INTRODUCTION

White Paper CLINICAL RESEARCH IN BELGIUM AN INTRODUCTION White Paper CLINICAL RESEARCH IN BELGIUM AN INTRODUCTION Table of Contents 1. Introduction... 3 2. Clinical Research Activity in Belgium... 3 3. The Regulatory Landscape in Belgium... 3 4. The Healthcare

More information

Regulatory approval routes in the European System for Medicinal Products

Regulatory approval routes in the European System for Medicinal Products Regulatory approval routes in the European System for Medicinal Products Cardiovascular Combination Pharmacotherapy Global Summit, Melbourne, 8 th May 2014 Presented by: Kevin Blake Human Medicines Research

More information

Health Products and Food Branch. www.hc-sc.gc.ca

Health Products and Food Branch. www.hc-sc.gc.ca Health Products and Food Branch 1 HEALTH CANADA PART C DIVISION 5 - DRUGS FOR CLINICAL TRIALS INVOLVING HUMAN SUBJECTS Part C - Division 5 2 Part A: Part B: Part C: Part D: Part E: Part G: Part J: Administration

More information

EMA Update Clinical Trials

EMA Update Clinical Trials EMA Update Clinical Trials Fergus Sweeney, Head, Compliance and Inspections, European Medicines Agency 16 October 2012 An agency of the European Union Disclaimer The views presented in this presentation/these

More information

Agence nationale de sécurité du médicament et des produits de santé (ANSM) Unités Essais Cliniques de médicaments. aec-essaiscliniques@ ansm.sante.

Agence nationale de sécurité du médicament et des produits de santé (ANSM) Unités Essais Cliniques de médicaments. aec-essaiscliniques@ ansm.sante. Medicinal Products for Human Use - FRANCE Competent authority Contact Details Contact Name 1 Agence nationale de sécurité du médicament et des produits de santé (ANSM) Contact Name 2 Unités Essais Cliniques

More information

Health Canada s GCP Compliance Program. GCP Information Sessions November 2010

Health Canada s GCP Compliance Program. GCP Information Sessions November 2010 Your Health and Safety... Our priority Votre santé et votre Securité notre priorité Health Canada s GCP Compliance Program GCP Information Sessions November 2010 Objective To describe the role that Health

More information

Clinical trials management in Horizon 2020 projects. 22.01.2015 Brussels, Belgium Claudia Schacht Eurice GmbH

Clinical trials management in Horizon 2020 projects. 22.01.2015 Brussels, Belgium Claudia Schacht Eurice GmbH in Horizon 2020 projects Claudia Schacht Eurice GmbH What is a clinical trial in H2020? Template for essential information to be provided for proposals including clinical trials / studies / investigations

More information

Questions & answers on signal management

Questions & answers on signal management 23 October 2015 EMA/261758/2013 Inspections and Human Medicines Pharmacovigilance Division This document addresses a number of questions which stakeholders, in particular marketing authorisation holders

More information

UK Implementation of the EU Clinical Trial Directive 2001/20/EC:

UK Implementation of the EU Clinical Trial Directive 2001/20/EC: UK Implementation of the EU Clinical Trial Directive 2001/20/EC: GCP Aspects. Dr. Colin Wilsher, FRQA. BARQA GCP Committee Chairman; & Pfizer Worldwide Development Quality Assurance. GIQAR, Roma, October

More information

EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL. Brussels, ENTR/F2/BL D(2003) CT 1 Revision 2

EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL. Brussels, ENTR/F2/BL D(2003) CT 1 Revision 2 EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single market : management & legislation for consumer goods Pharmaceuticals : regulatory framework and market authorisations Brussels, ENTR/F2/BL D(2003)

More information

Wissenschaftliche Prüfungsarbeit. zur Erlangung des Titels. Master of Drug Regulatory Affairs

Wissenschaftliche Prüfungsarbeit. zur Erlangung des Titels. Master of Drug Regulatory Affairs TITLE PAGE The new Clinical Trial Regulation and corresponding new EU portal and database: an opportunity to enhance standardisation and interoperability in regulatory systems Wissenschaftliche Prüfungsarbeit

More information

REGULATORY ENVIRONMENT

REGULATORY ENVIRONMENT 1. Introduction REGULATORY ENVIRONMENT Research and development work, pre-clinical tests, clinical studies, facilities, and the manufacture and sale of the Company s products are and will continue to be

More information

Clinical Trials Facilitation Groups

Clinical Trials Facilitation Groups Clinical Trials Facilitation Groups Guidance document for a Voluntary Harmonisation Procedure (VHP) for the assessment of multinational Clinical Trial Applications Version 2 Table of contents Doc. Ref.:

More information

Marketing Authorization Procedures in the European Union Making the Right Choice

Marketing Authorization Procedures in the European Union Making the Right Choice Life science i technical bulletin ISSUE N 33 /DECEMBER 2009 Marketing Authorization Procedures in the European Union Making the Right Choice AUTHOR: Arash Ghalamkarpour, PhD, Regulatory Affairs Associate,

More information

Implementation strategy for ISO IDMP in EU

Implementation strategy for ISO IDMP in EU Implementation strategy for ISO IDMP in EU Paolo Alcini Head of Data Standardisation and Analytics Business Data & Analytics Information Management EMA An agency of the European Union The EU ISO IDMP Task

More information

and Regulatory Aspects

and Regulatory Aspects Good Clinical Practice and Regulatory Aspects Nora Espiritu MD, MPh, PhD (c) Former Executive Director of Research and Technology Transfer. Peruvian National Institute t of Health. Member of the Ethics

More information

Competentes en Medicamentos

Competentes en Medicamentos VIII Encuentro de Autoridades Competentes en Medicamentos de los Países Iberoamericanos (EAMI) 12-14 de Mayo 2010 Madrid MARTIN TERBERGER Jefe de la Unidad de Productos Farmacéuticos Nuevas iniciativas

More information

Clinical Study Startup Timelines in Central and Eastern Europe

Clinical Study Startup Timelines in Central and Eastern Europe Vol. 11, No. 10, October 2015 Happy Trials to You Clinical Study Startup Timelines in Central and Eastern Europe By Vlad Bogin The complexity of regulatory approval pathways and time to first-site initiation

More information

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) European Medicines Agency Evaluation of Medicines for Human Use London, 19 July 2007 Doc. Ref: EMEA/27170/2006 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON COMPASSIONATE USE OF MEDICINAL

More information

Role of IRB/IEC in GCP. Benjamin Kuo, MD, Dr.PH, CIP.

Role of IRB/IEC in GCP. Benjamin Kuo, MD, Dr.PH, CIP. Role of IRB/IEC in GCP Benjamin Kuo, MD, Dr.PH, CIP. Institutional Review Board (IRB) An independent body constituted of medical, scientific and non scientific members Responsible for ensuring protection

More information

The EFGCP Report on The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2011) Norway

The EFGCP Report on The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2011) Norway The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2011) Norway Question 1: What laws or regulations apply to an application for conducting a clinical

More information

APEC Preliminary Workshop: Review of Drug

APEC Preliminary Workshop: Review of Drug APEC Preliminary Workshop: Review of Drug Development in Clinical Trials Session 1.4 -Clinical Trial Environment United States (FDA) and European Union (EMEA) Susan D Amico Vice President and Global Head

More information

CLINICAL RESEARCH IN EUROPE AFTER THE EU DIRECTIVE ON CLINICAL TRIALS. DOMENICO CRISCUOLO, MD, FFPM CMO at CREABILIS THERAPEUTICS IFAPP PAST PRESIDENT

CLINICAL RESEARCH IN EUROPE AFTER THE EU DIRECTIVE ON CLINICAL TRIALS. DOMENICO CRISCUOLO, MD, FFPM CMO at CREABILIS THERAPEUTICS IFAPP PAST PRESIDENT CLINICAL RESEARCH IN EUROPE AFTER THE EU DIRECTIVE ON CLINICAL TRIALS DOMENICO CRISCUOLO, MD, FFPM CMO at CREABILIS THERAPEUTICS IFAPP PAST PRESIDENT EU : SOME FACTS 25 MEMBERS + 3 CANDIDATES 500.000.000

More information

Adoption by GCP Inspectors Working Group for consultation 14 June 2011. End of consultation (deadline for comments) 15 February 2012

Adoption by GCP Inspectors Working Group for consultation 14 June 2011. End of consultation (deadline for comments) 15 February 2012 10 December 2013 EMA/INS/GCP/600788/2011 Compliance and Inspection Reflection paper on the use of interactive response technologies (interactive voice/web response systems) in clinical trials, with particular

More information

PHV- 4 version 1 ELECTRONIC ADVERSE DRUG REACTION REPORTING

PHV- 4 version 1 ELECTRONIC ADVERSE DRUG REACTION REPORTING PHV- 4 version 1 ELECTRONIC ADVERSE DRUG REACTION REPORTING This guideline supersedes guideline PHV 4 as of September 16 2008. 1. Introduction and general provisions 1.1 Purpose of the guideline The guideline

More information

OECD Recommendation on the Governance of Clinical Trials

OECD Recommendation on the Governance of Clinical Trials OECD Recommendation on the Governance of Clinical Trials Marketing authorisation status of the medicinal products Non-authorised medicine Authorised medicine, treatment regimen outside

More information

End of consultation (deadline for comments) 14 October 2009. Adoption by Committee for advanced therapies 15 October 2010

End of consultation (deadline for comments) 14 October 2009. Adoption by Committee for advanced therapies 15 October 2010 15 October 2010 EMA/CAT/418458/2008/corr. Committee for advanced therapies (CAT) Procedural advice on the certification of quality and nonclinical data for small and medium sized enterprises developing

More information

Summary of the role and operation of NHS Research Management Offices in England

Summary of the role and operation of NHS Research Management Offices in England Summary of the role and operation of NHS Research Management Offices in England The purpose of this document is to clearly explain, at the operational level, the activities undertaken by NHS R&D Offices

More information

The role, duties and responsibilities of clinical trials personnel Monitoring: rules and recommendations

The role, duties and responsibilities of clinical trials personnel Monitoring: rules and recommendations The role, duties and responsibilities of clinical trials personnel Monitoring: rules and recommendations Maria Luisa Paoloni OPBG Clinical & Research Services Monitoring and Responsible of monitoring:

More information

Marketing Authorisation: The Evaluation Process

Marketing Authorisation: The Evaluation Process 1 st EMEA Workshop for Micro, Small and Medium- Sized Enterprises (SMEs) Navigating the Regulatory Maze Marketing Authorisation: The Evaluation Process Dr Evdokia Korakianiti Scientific Administrator Centralised

More information

Trust/Host Site Approval. Presented by: Anika Kadchha Research Governance Officer

Trust/Host Site Approval. Presented by: Anika Kadchha Research Governance Officer Trust/Host Site Approval Presented by: Anika Kadchha Research Governance Officer Joint Research & Enterprise Office Training 19 th January Outline What is Research NHS Ethics (if required) Host Site Approval

More information

Guidance Notes for Applicants of the Certificate for Clinical Trial on Medical Device

Guidance Notes for Applicants of the Certificate for Clinical Trial on Medical Device Guidance Notes for Applicants of the Certificate for Clinical Trial on Medical Device List of Contents Page 1. Introduction 1.1 The Medical Device Administrative Control System and the 3 proposed legislation

More information

Guide to Clinical Trial Applications

Guide to Clinical Trial Applications Guide to Clinical Trial Applications AUT-G0001-9 DATE 29 JUNE 2015 This guide does not purport to be an interpretation of law and/or regulations and is for guidance purposes only. CONTENTS ABBREVIATIONS

More information

EUROPEAN INDUSTRIAL PHARMACISTS GROUP

EUROPEAN INDUSTRIAL PHARMACISTS GROUP EUROPEAN INDUSTRIAL PHARMACISTS GROUP Guide to Good Regulatory Practice Acknowledgments: Valérie LACAMOIRE, Conseil Central de la section B de l Ordre des Pharmaciens Kelsey MOWER, Industrial Pharmacists

More information

Guidelines. of 16.05.2013

Guidelines. of 16.05.2013 EUROPEAN COMMISSION Brussels, 16.05.2013 C (2013) 2804 Guidelines of 16.05.2013 on the details of the various categories of variations, on the operation of the procedures laid down in Chapters, a, I and

More information

Job Profile Clinical Research Associate III (CRA)

Job Profile Clinical Research Associate III (CRA) PART 1 - PROFILE You are an experienced CRA with a strong background in Clinical Research who is passionate about drug development and are seeking a challenging and rewarding career in a quality focussed

More information

Emergence of Compassionate Use programmes

Emergence of Compassionate Use programmes Emergence of Compassionate Use programmes Rosanna Melchior, PharmD, MS IDRAC, Thomson Scientific Overview What is compassionate use (CU) Overview of CU in Europe Authorities and Sponsors Roles and Responsibilities

More information

Questions and answers on post approval change management protocols

Questions and answers on post approval change management protocols 30 March 2012 EMA/CHMP/CVMP/QWP/586330/2010 Committee for Medicinal Products for Human Use (CHMP) Questions and answers on post approval change management protocols Draft agreed by CHMP / CVMP Quality

More information

Industry Experience in Clinical Trials Management. Catherine Lee Area Head Clinical Operations Asia Pfizer Inc 20 May 2011 Brussels

Industry Experience in Clinical Trials Management. Catherine Lee Area Head Clinical Operations Asia Pfizer Inc 20 May 2011 Brussels Industry Experience in Clinical Trials Management Catherine Lee Area Head Clinical Operations Asia Pfizer Inc 20 May 2011 Brussels Stakeholders in clinical research Critical activities to ensure patient

More information

Clinical trials: The EU perspective. Dr Karim Berkouk, Deputy Head of Unit DG for Research and Innovation Health Directorate European Commission

Clinical trials: The EU perspective. Dr Karim Berkouk, Deputy Head of Unit DG for Research and Innovation Health Directorate European Commission Clinical trials: The EU perspective Dr Karim Berkouk, Deputy Head of Unit DG for Research and Innovation Health Directorate European Commission Content 1.EU: The global picture 2.EU & Clinial trials: The

More information

EORTC position on the place for transparency in the clinical trials regulation

EORTC position on the place for transparency in the clinical trials regulation EORTC position on the place for transparency in the clinical trials regulation EORTC fully supports the need to increase transparency of clinical trials. Appropriate transparency within the clinical trials

More information

Can we ease the ethical review of Clinical. (within current/ future law)

Can we ease the ethical review of Clinical. (within current/ future law) Can we ease the ethical review of Clinical Trials in the EU? (within current/ future law) A non-legislative proposal to develop accreditation & mutual recognition between EU Member State RECs Esteban Herrero-Martinez:

More information

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON DATA MONITORING COMMITTEES

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON DATA MONITORING COMMITTEES European Medicines Agency Pre-authorisation Evaluation of Medicines for Human Use London, 27 July 2005 Doc. Ref. EMEA/CHMP/EWP/5872/03 Corr COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE

More information

The Ontario Cancer Research Ethics Board Overview

The Ontario Cancer Research Ethics Board Overview The Ontario Cancer Research Ethics Board Overview Research Ethics Research ethics review is vital to the advancement of ethically sound research. Before individuals can be enrolled in a research study,

More information

20 & 21 October 2005 Clinical trials Risk issues within a wider Europe. Adrien Collovray Marsh Life Science Conference 2005 Berlin, Germany

20 & 21 October 2005 Clinical trials Risk issues within a wider Europe. Adrien Collovray Marsh Life Science Conference 2005 Berlin, Germany 20 & 21 October 2005 Clinical trials Risk issues within a wider Europe Adrien Collovray Life Science Conference 2005 Berlin, Germany Clinical trials EC Directive on clinical trials Insurance Requirements

More information

Guideline on good pharmacovigilance practices (GVP)

Guideline on good pharmacovigilance practices (GVP) 1 2 20 February 2012 EMA/541760/2011 3 4 Guideline on good pharmacovigilance practices (GVP) Module I Pharmacovigilance systems and their quality systems Draft finalised by the Agency in collaboration

More information

CMDv/BPG/001. BEST PRACTICE GUIDE for Veterinary Mutual Recognition Procedure (MRP) Edition 04. Edition date: 19 July 2013

CMDv/BPG/001. BEST PRACTICE GUIDE for Veterinary Mutual Recognition Procedure (MRP) Edition 04. Edition date: 19 July 2013 EMA/CMDv/83618/2006 BEST PRACTICE GUIDE for Veterinary Mutual Recognition Procedure (MRP) Edition 04 Edition date: 19 July 2013 Implementation date: 23 November 2006 CMDv Secretariat: European Medicines

More information

European Commission Contract no. FIF.2004 0828: Users Guide to European Regulation in Biotechnology. Final Report, Part I: Complete text

European Commission Contract no. FIF.2004 0828: Users Guide to European Regulation in Biotechnology. Final Report, Part I: Complete text European Commission Contract no. FIF.2004 0828: Users Guide to European Regulation in Biotechnology Final Report, Part I: Complete text Page 1 USERS GUIDE TO EUROPEAN REGULATION IN BIOTECHNOLOGY CONTENTS

More information

Guidance on the In Vitro Diagnostic Medical Devices Directive 98/79/EC

Guidance on the In Vitro Diagnostic Medical Devices Directive 98/79/EC Guidance on the In Vitro Diagnostic Medical Devices Directive 98/79/EC August 2013 Contents 1 Introduction...3 2 Scope of the directive...3 2.1 What is an in vitro diagnostic medical device?... 3 2.2 Specimen

More information

Pediatric Research Networks A Plan for a Collaboration in Europe. Daniela Gunz Head Clinical Trial Operations Switzerland June 9, 2011

Pediatric Research Networks A Plan for a Collaboration in Europe. Daniela Gunz Head Clinical Trial Operations Switzerland June 9, 2011 Pediatric Research Networks A Plan for a Collaboration in Europe Daniela Gunz Head Clinical Trial Operations Switzerland June 9, 2011 Agenda Challenges in clinical research in children EU pediatric regulation

More information