EMA Update Clinical Trials
|
|
- Georgiana Randall
- 7 years ago
- Views:
Transcription
1 EMA Update Clinical Trials Fergus Sweeney, Head, Compliance and Inspections, European Medicines Agency 16 October 2012 An agency of the European Union
2 Disclaimer The views presented in this presentation/these slides are those of the author and should not be understood or quoted as being made on behalf of the EMA and/or its scientific committees 2
3 EMA Update Some background numbers Risk based approaches to clinical trials Commission proposal on a regulation for clinical trials Clinical Trial transparency EudraCT and EU CTR Clinical trial reports and data from Marketing Authorisation Dossiers 3
4 The Dilemna Between 2005 and ,891 Patients in pivotal trials (38.11% in Europe, 34.05% in North America, 2.58% Africa, 9.36% Middle East/Asia Pacific, 4.44% CIS, 9.36 % Latin America, 2.1% other) 70,291 clinical trial sites in c. 106countries c. 485 new MAA applications plus line extensions etc, 265 GCP inspections
5 5
6
7
8 Risk Based Approaches to Clinical Trials 8
9 Regulatory Requirements and guidelines Directive 2001/20/EC and directive 2005/28/EC Directive 2001/83/EC Annex 1 National Legislation General guidelines GCP, Statistical analysis, Clinical study report, Clinical trials in paediatric or elderly populations Guidelines on clinical development of medicinal products in specific therapeutic areas Scientific advice (non-binding) optional possibility for sponsor to seek scientific advice on the development of a medicine - clinical, pre-clinical, pharmaceutical 9
10 Regulatory requirements for clinical trial design Legislation is general broad principles. More information is in guidance offers considerable flexibility, and reasonable departures, better alternatives can be justified case by case. An awful lot of detail is in established practice, perceived requirements, the oral and written culture which is very open to change. Many of the issues lie in this cultural category as do the obstacles to change. 10
11 Defining Quality Quality sufficient to support the decision making process on medicines throughout the clinical development and use post-marketing authorisation Collecting data, generating information, enabling decision making by: Sponsors Ethics Committees Regulators Investigators Healthcare professionals Study subjects Patients 11 Ensuring: Subject rights, safety and welfare Robustness of data
12 Current developments helping to make that flexibility clear and put into practice EU GCP IWG/CTFG Reflection paper on risk based quality management OECD Draft Recommendation on risk based approach endorsed work on final text in progress FDA Draft guidance on monitoring EU GCP IWG / CHMP draft Points to consider on GCP inspection findings and the benefit-risk balance EU Draft regulation on clinical trials published 12
13 13
14 14
15 Introduction and problem statement Purpose of the paper - facilitate the development of a more: systematic, prioritised, risk-based approach to quality management of clinical trials, to support the principles of GCP and to complement existing quality practices, requirements and standards. Problem can be summarised: current practices are not proportionate nor well adapted to achieving the desired goals generally very costly, resulting either in success at an unnecessarily high cost or failure which is also very costly. The 15 origins of the problem are multifactorial.
16 FEEDBACK RECEIVED VERY WELCOME - Focus more on trial protocol design and clinical implications. Sponsored trials - more attention should be paid to academic trials Describe central monitoring Encourage use of technological advances Standardise/harmonise risk based monitoring approaches put forward by EMA and FDA Need for standardization, protocols, data collection tools, reporting formats Examples of tolerance limits, windows.. Protocol specific and general approaches. There are also risks linked to data analysis and reporting receive too little attention. First Stakeholder Workshop May 2012 Finalize and publish Q Establish and share experience Case Study Workshop Q1 2013
17 Draft Points to consider on GCP inspection findings and the benefit-risk balance Agreed by GCP IWG, for discussion/adoption by CHMP October Publication once adopted. Discussion paper on key GCP inspection issues impacting risk / benefit considerations by CHMP. Objective - to assist inspectors and assessors in evaluating the consequences of inspection findings in relation to the benefit-risk balance. Building prioritisation and risk assessment into conclusions and decisions based on inspection. Three categories are used: Inspection findings which are likely to influence the benefit-risk evaluation Inspection findings which may influence the benefit-risk evaluation Inspection findings which are less likely to influence the benefit-risk evaluation 17
18 Perfection is achieved, not when there is nothing more to add, but when there is nothing left to take away. Antoine de Saint-Exupéry, 18
19 Commission Proposal for a Regulation on Clinical Trials 19
20 Draft regulation on clinical trials Key features: Single dossier, single application portal for EU, encompassing regulatory and ethics review. Joint assessment of core information Part 1 between involved member states and national assessment of Part 2. Single decision per trial and per member state. Low intervention trials marketed product within SPC or established medical practice rapid assessment, dossier is simple, additional labeling only if required by study design. Emergency treatment trials Insurance, labeling Introduced by EU Commission to Council of Member States and then EU Parliament for codecision 20
21 Transparency EudraCT - confidential database - as of Sep ,604 clinical trial applications, representing 34,833 clinical trial protocols EU CTR (EU Clinical Trial Register) public 19,146 clinical trials now available in public domain (all EudraCT trials except adult phase I trials can be made public) Commission guidance on inclusion summary of trial results in EudraCT and EU CTR now published as final, implementation in Clinical study reports from Marketing Authorisation Application dossiers. Can be made available once the decision is finalised. EMA can do this reactively but is looking at how to do so pro-actively. 21
22 Thank you questions suggestions Suggestions for next steps, case study workshops, Q and As etc to GCP@ema.europa.eu and cc: Noemie.Manent@ema.europa.eu Subject line Risk based quality management 22
Clinical trials in developing countries submitted to EMEA for regulatory purposes
Clinical trials in developing countries submitted to EMEA for regulatory purposes Rome, UNICRI/AIFA December 2008 Hans-Georg Eichler Agenda Challenges EU regulatory requirements for clinical trials Facts
More informationThe 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 informationThe 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 informationClinical 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 informationThe 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 informationClinical 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 informationEU 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 informationEU Clinical Trials Register. www.clinicaltrialsregister.eu. An agency of the European Union
EU Clinical Trials Register www.clinicaltrialsregister.eu An agency of the European Union The EU Clinical Trials Register provides public access to information from the European Union (EU) clinical trial
More informationOversight of Clinical Trials in Europe - Member State perspective. Gunnar Danielsson Senior Expert Pharmaceutical Inspector
Oversight of Clinical Trials in Europe - Member State perspective Gunnar Danielsson Senior Expert Pharmaceutical Inspector Oversight of Clinical Trials Oversight of clinical trials occur on many different
More informationThis 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 informationWhite 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 informationThe European regulatory system for medicines and the European Medicines Agency
The European regulatory system for medicines and the European Medicines Agency A consistent approach to medicines regulation across the European Union An agency of the European Union This booklet is intended
More informationRegulation 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 informationThe 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 informationStrong 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 informationEnd 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 informationSheffield Kidney Institute. Planning a Clinical Trial
Planning a Clinical Trial Clinical Trials Testing a new drug Ethical Issues Liability and Indemnity Trial Design Trial Protocol Statistical analysis Clinical Trials Phase I: Phase II: Phase III: Phase
More informationICRIN 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 informationEarly 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 informationHow To Understand The Paediatric Regulation
Paediatric Use Marketing Authorisation (PUMA) from a National Competent Authority Point of View DGRA Annual Congress 2006 Bonn, 10. May 2006 Dr. Susanne Keitel Content PUMA The Future Background Legislative
More informationStrategy and pilot phase for patient registries
Strategy and pilot phase for patient registries Draft still under discussion Industry Stakeholder Platform - Operation of EU Pharmacovigilance Legislation 12 January 2015 Xavier Kurz, Head of Monitoring
More informationTRANSATLANTIC TRADE AND INVESTMENT PARTNERSHIP
DISCLAIMER: The EU reserves the right to make subsequent modifications to this text and to complement its proposals at a later stage, by modifying, supplementing or withdrawing all, or any part, at any
More informationEFPIA 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 informationQuestions & 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 informationEFPIA 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 informationLifecycle CMC Management: ICH Q12 Progress to date
Lifecycle CMC Management: ICH Q12 Progress to date BWP/QWP/GMDP IWG Industry European workshop 28-29 October 2015 Jean-Louis ROBERT (EU) Graham Cook (EFPIA) Please take note The following slides represent
More informationThe 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 informationClinical trials submitted in marketing-authorisation applications to the European Medicines Agency
11 December 2013 EMA/INS/GCP/676319/2012 Compliance and Inspection Clinical trials submitted in marketing-authorisation applications to the European Medicines Agency Overview of patient recruitment and
More informationThe 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 informationSubmission of comments on 'Policy 0070 on publication and access to clinical-trial data'
EMA/240810/2013 Submission of comments on 'Policy 0070 on publication and access to clinical-trial data' s from: Name and affiliation PHARMIG - Association of the Austrian pharmaceutical industry Please
More informationAdoption 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 informationGuideline 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 informationCompetentes 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 informationRegulatory 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 informationThe 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 informationThe 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 informationEMA policy on publication of Clinical Data. SFdS - Journée Annuelle du groupe Biopharmacie & Santé
EMA policy on publication of Clinical Data Two main objectives In the interest of public health: To enable public scrutiny - To establish trust and confidence in the system To enable application of new
More informationMarketing 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 informationAgence 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 informationPharmaceutical Quality & Clinical Research Quality: The Interaction
4 th Jerusalem Conference: Quality by Design (QbD)) & Pharma Sciences, May 20-22, 2014 The Edmund Safra Campus, The Hebrew University of Jerusalem Pharmaceutical Quality & Clinical Research Quality: The
More informationPROCEDURE 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 informationIntroduction to Q10 Pharmaceutical Quality System
ICH-GCG Asean Training Workshop on ICH Guidelines Q8,Q9 and Q10 (New Paradigm) Introduction to Q10 Pharmaceutical Quality System Georges FRANCE, Q- IWG Kuala Lumpur, Malaysia 26-28 July 2010 International
More informationCOMMITTEE 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 informationThe EMA current activities towards ISO IDMP implementation
The EMA current activities towards ISO IDMP implementation An overview Ginas meeting 11 June 2014 Presented by: Ilaria Del Seppia, B-BD-DCM EMA An agency of the European Union Outlines EMA Vision: Objectives
More informationEDQM Certificates of Suitability: Cooperation Among Inspectorates in Europe And Beyond
EDQM Certificates of Suitability: Cooperation Among Inspectorates in Europe And Beyond 14 th International Conference of Drug Regulatory Authorities Pre-ICDRA Meeting Dr Susanne Keitel European Directorate
More informationBiotech 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 informationEmerging Device Topics for Regulatory Consideration.. Janine Jamieson May 2015
Emerging Device Topics for Regulatory Consideration. Janine Jamieson May 2015 Disclaimer These are my personal views and not necessarily those of MHRA as an organisation. 2 European regulation of combination
More informationEuropean 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 informationReport to the European Commission on Pharmacovigilance audits carried out in the Medicines Evaluation Board, The Netherlands period of time from
Report to the European Commission on Pharmacovigilance audits carried out in the Medicines Evaluation Board, The Netherlands period of time from September 2013 to September 2015 1. INTRODUCTION Applicable
More informationGuidance 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 informationGuideline on good pharmacovigilance practices (GVP)
22 June 2012 EMA/541760/2011 Guideline on good pharmacovigilance practices (GVP) Module I Pharmacovigilance systems and their quality systems Draft finalised by the Agency in collaboration with Member
More informationAdoption by CHMP for release for consultation November 2010. End of consultation (deadline for comments) 31 March 2011
1 2 3 November 2010 EMA/759784/2010 Committee for Medicinal Products for Human Use 4 5 6 7 Reflection paper on the need for active control in therapeutic areas where use of placebo is deemed ethical and
More informationOECD 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 informationEU Clinical Trials Regulation Regulation EU 536/2014
EU Clinical Trials Regulation Regulation EU 536/2014 María Jesús Zafra Director, QA & Compliance Table of contents 1 2 3 4 Introduction Timelines and main changes Highlights 5 Impact on company processes
More informationThe 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 informationClinical Trial Oversight: Ensuring GCP Compliance, Patient Safety and Data Integrity
Clinical Trial Oversight: Ensuring GCP Compliance, Patient Safety and Data Integrity Michelle Quaye Regulatory Manager, Advanced Therapy Trials University College London Overview The Principles of Good
More informationResources Based, Manufacturing and Consumer Goods Industries Chemicals Industry
EUROPEAN COMMISSION Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs Resources Based, Manufacturing and Consumer Goods Industries Chemicals Industry Version March 2015 QUESTIONS
More informationClinical 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 informationReflection paper on the Use of Interactive Response Technologies (Interactive Voice/Web Response Systems) in Clinical Trials
1 2 3 5 August 2011 EMA/INS/GCP/600788/2011 Compliance and Inspection 4 5 6 7 Reflection paper on the Use of Interactive Response Technologies (Interactive Voice/Web Response Systems) in Clinical Trials
More informationAim of today s meeting/teleconference
Finalisation of EMA policy on publication of and access to clinical trial data Targeted consultation with key stakeholders May 2014 Presented by: Noël Wathion Chief Policy Adviser An agency of the European
More informationDriving improved access to treatment via Europe and through national MS Societies
EMSP 2014 Spring Conference Driving improved access to treatment via Europe and through national MS Societies Christoph Thalheim EMSP Luiza Wieczynska PTSR 1 The pharmaceutical industry is suffering Expiring
More informationCOMMITTEE 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 informationFederal 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 informationOfficial Journal of the European Union. (Acts whose publication is obligatory)
27.12.2006 L 378/1 I (Acts whose publication is obligatory) REGULATION (EC) No 1901/2006 OF THE EUROPEAN PARLIAMT AND OF THE COUNCIL of 12 December 2006 on medicinal products for paediatric use and amending
More informationClinical trials in haemophilia
Clinical trials in haemophilia Dr. Paul Giangrande Oxford Haemophilia and Thrombosis Centre & Nuffield Department of Clinical Medicine University of Oxford paul.giangrande@ndm.ox.ac.uk Why do clinical
More informationEUCERD RECOMMENDATIONS QUALITY CRITERIA FOR CENTRES OF EXPERTISE FOR RARE DISEASES IN MEMBER STATES
EUCERD RECOMMENDATIONS QUALITY CRITERIA FOR CENTRES OF EXPERTISE FOR RARE DISEASES IN MEMBER STATES 24 OCTOBER 2011 INTRODUCTION 1. THE EUROPEAN CONTEXT Centres of expertise (CE) and European Reference
More informationCLINICAL TRIALS IN DEVELOPING COUNTRIES:
DIRECTORATE-GENERAL FOR EXTERNAL POLICIES OF THE UNION DIRECTORATE B - POLICY DEPARTMENT - STUDY CLINICAL TRIALS IN DEVELOPING COUNTRIES: HOW TO PROTECT PEOPLE AGAINST UNETHICAL PRACTICES? EXPO/B/DEVE/2008/45
More informationSETTING 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 informationEnabling Discovery, Development, and translation of treatments for Cognitive Dysfunctions in Depression: A Workshop Session IV
Enabling Discovery, Development, and translation of treatments for Cognitive Dysfunctions in Depression: A Workshop Session IV Maria Isaac, MASc, MD, PhD, MFPM, Psychiatrist Senior Scientific Officer Institute
More informationClinical evaluation Latest development in expectations EU and USA
Clinical evaluation Latest development in expectations EU and USA Medical Devices: staying ahead of regulatory developments Gert Bos BSI Israel 22 April - Herzliya Copyright 2012 BSI. All rights reserved.
More informationReflection Paper on Medicinal Product Supply Shortages Caused by Manufacturing/GMP Compliance Problems
14 September 2012 /590745/2012 Patient Health Protection Reflection Paper on Medicinal Product Supply Shortages Caused by Manufacturing/GMP 1. Introduction Ensuring the security and Good Manufacturing
More informationVOLUME 2A Procedures for marketing authorisation CHAPTER 1 MARKETING AUTHORISATION. November 2005
EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Consumer goods Pharmaceuticals Brussels, ENTR/F2/BL D(2002) NOTICE TO APPLICANTS Revision 3 VOLUME 2A Procedures for marketing authorisation CHAPTER 1
More informationNovartis Investigator Initiated Trials (IITs) Guidelines
Novartis Investigator Initiated Trials (IITs) Guidelines Introduction and background As part of our commitment to delivering innovative therapies to patients worldwide, Novartis believes in the need to
More informationGUIDELINES ON MEDICAL DEVICES
EUROPEAN COMMISSION DIRECTORATE GENERAL for HEALTH and CONSUMERS Consumer Affairs Health technology and Cosmetics MEDDEV 2.12/2 rev2 January 2012 GUIDELINES ON MEDICAL DEVICES POST MARKET CLINICAL FOLLOW-UP
More informationEUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL
Ref. Ares(2011)1044649-03/10/2011 EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Health systems and products Pharmaceuticals SANCO/D3/RSR/iv(2011)ddg1.d3. 1137738 Update 1 October 2011 HANDLING
More informationWork plan for GMP/GDP Inspectors Working Group for 2016
21 December 2015 EMA/INS/GMP/738756/2015 Compliance and Inspection Work plan for GMP/GDP Inspectors Working Group for 2016 Chairperson: Status David Cockburn January 2016 1. Meetings scheduled for 2016
More informationTemplate 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 informationGuideline on good pharmacovigilance practices (GVP)
19 April 2013 EMA/813938/2011 Rev 1* Guideline on good pharmacovigilance practices (GVP) Module VIII Post-authorisation safety studies (Rev 1) Draft of first version finalised by the Agency in collaboration
More informationWelcome to the training on the TransCelerate approach to Risk-Based Monitoring. This course will take you through five modules of information to
Welcome to the training on the TransCelerate approach to Risk-Based Monitoring. This course will take you through five modules of information to introduce you to the concepts behind risk-based monitoring,
More informationEORTC 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 informationThe compassionate use of medicinal products.
The compassionate use of medicinal products. The French ATU system C. Bélorgey Head of Department of evaluation of Clinical Trials and Medicinal products of special status ECRD 23 May 2012 Disclaimer Employee
More informationOverview 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 informationRegulatory Reform: Are we heading in the right direction?
Regulatory Reform: Are we heading in the right direction? Trisha Garrett, Assistant Secretary, Complementary and OTC Medicines Branch 11 November 2015 Where are we going? 2 Update TGA Update 1. TGA restructure
More informationComments from EASAC and FEAM on the In vitro diagnostic medical devices Regulation
Comments from EASAC and FEAM on the In vitro diagnostic medical devices Regulation Introduction The proposed Regulations on medical devices represent an important initiative to strengthen the characterisation
More informationDate : 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 informationQuality Risk Management The Pharmaceutical Experience Ann O Mahony Quality Assurance Specialist Pfizer Biotech Grange Castle
Quality Risk Management 11 November 2011 Galway, Ireland Quality Risk Management The Pharmaceutical Experience Ann O Mahony Quality Assurance Specialist Pfizer Biotech Grange Castle Overview Regulatory
More informationWhat is the correct title of this publication? What is the current status of understanding and implementation?
GMP Rules and Guidelines in 2013 for Computer System Validation / Computerises Systems / Electronic Records and Signatures/ IT Infrastructure and Application Compliance: What is the correct title of this
More informationVOLUME 2A Procedures for marketing authorisation CHAPTER 1 MARKETING AUTHORISATION. June 2013
EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Health systems and products Medicinal products Revision 4 NOTICE TO APPLICANTS VOLUME 2A Procedures for marketing authorisation CHAPTER 1 MARKETING
More informationGUIDELINES FOR RETENTION OF CLINICAL TRIAL RECORDS AT INVESTIGATOR STUDY SITES
1 GUIDELINES FOR RETENTION OF CLINICAL TRIAL RECORDS AT INVESTIGATOR STUDY SITES INTRODUCTION During the conduct of a clinical trial, large quantities of documentation are generated both by the sponsor
More informationSerious 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 information1 www.imarcresearch.com
Risk Management in Clinical Research: PROCESS DEVELOPMENT & APPLICATION Introduction Recently, two key pieces of guidance were released from Food and Drug Administration (FDA) and European Medicines Agency
More informationReflection paper on risk based quality management in clinical trials
18 November 2013 EMA/269011/2013 Compliance and Inspection Reflection paper on risk based quality management in clinical trials Draft Agreed by the Clinical Trial Facilitation Group (CTFG) for release
More informationJoint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases 1 Updated November 10, 2009
Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases 1 Updated November 10, 2009 The innovative pharmaceutical industry 2 is committed to the transparency
More informationQuality Assurance Framework
Quality Assurance Framework 29 August 2014 Version 1.1 Review date: 1 September 2015 Introduction Quality Assurance is one of the Academy for Healthcare Science s (AHCS) six Strategic Objectives 1. The
More informationStakeholder Meeting, 7 th June 2013 An inspector s perspective considerations for patient support and reimbursement programmes
Stakeholder Meeting, 7 th June 2013 An inspector s perspective considerations for patient support and reimbursement programmes Dr Anya Sookoo, Expert Inspector, Inspections, Enforcement & Standards Division,
More informationSingapore Clinical Trials Register. Foo Yang Tong Director Clinical Trials Branch Health Products Regulation Group HEALTH SCIENCES AUTHORITY
Singapore Clinical Trials Register Foo Yang Tong Director Clinical Trials Branch Health Products Regulation Group HEALTH SCIENCES AUTHORITY Clinical Trial Register Global Trend EMA: EU Clinical Trials
More informationWhat We Are..! www.ardent-cro.com
Your Trusted CRO! Regus, Level-2, Connaught Place, Bund Garden Road, Pune-411001, MH, India. Phone: 020-65-31-31-71 Email: ardent@ardent-cro.com Web: What We Are..! Ardent Clinical Research Services is
More informationICH guideline Q10 on pharmaceutical quality system
September 2015 EMA/CHMP/ICH/214732/2007 Committee for Human Medicinal Products Step 5 Transmission to CHMP May 2007 Transmission to interested parties May 2007 Deadline for comments November 2007 Final
More informationTGA key performance indicators and reporting measures
TGA key indicators and reporting measures Regulator Performance Framework Version 1.0, May 2015 About the Therapeutic Goods Administration (TGA) The Therapeutic Goods Administration (TGA) is part of the
More informationUS Perspective on the Regulatory Assessment of Benefit-Risk of Vaccines
US Perspective on the Regulatory Assessment of Benefit-Risk of Vaccines Norman W. Baylor Biologics Consulting Group, Inc. 23-25 June 2014 Foundation Merieux Conference Center OUTLINE OF PRESENTATION Introduction
More information