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e-COMPENDIUM [electronic document] . - Brussel [Belgium] : Pharma.be, 2008.
dagelijk update
Languages : Dutch (dut)
Descriptors: Classification
QV 13 Pharmacology. Dictionaries. Encyclopedias
Indexation
Databases, Web ; Dictionaries, Pharmaceutic ; Dose-Response Relationship, Drug ; Pharmaceutical PreparationsContents note: * De originele wetenschappelijke bijsluiters van geneesmiddelen voor humaan en diergeneeskundig gebruik.
* Samenvattingen van de wetenschappelijke bijsluiters, opgesteld i.s.m. de Ecole de Santé Publique van de Université Libre de Bruxelles (ULB).
* Actuele prijs-en terugbetalingsinformatie van de geneesmiddelen.
Link for e-copy: http://www.e-compendium.be/ Format of e-copy: Online Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=1824 EPARs for authorised medicinal products for human use / London [UK] : European Medicines Agency (EMEA) (2009)
EPARs for authorised medicinal products for human use [electronic document] . - London [UK] : European Medicines Agency (EMEA), 2009.
Languages : English (eng)
Descriptors: Classification
QV 13 Pharmacology. Dictionaries. Encyclopedias
Indexation
Databases, Factual ; Europe ; Pharmaceutical Preparations ; PharmacovigilanceAbstract: The EMEA publishes information on the products assessed by the Committee for Medicinal Products for Human Use (CHMP). Any positive opinion given by the Committee is published in the first instance as a Summary of Opinion. More detailed information is published later, following the granting of a Marketing Authorisation by the European Commission as an European Public Assessment Report (EPAR).
The European Public Assessment Report (EPAR) reflects the scientific conclusion reached by the Committee for Medicinal Products for Human Use (CHMP) at the end of the centralised evaluation process. The legal basis for its creation and availability is contained in Article 13(3) of Regulation (EC) No 726/2004. It is made available by the EMEA for information to the public, after deletion of commercially confidential information.
The EPAR provides a summary of the grounds for the CHMP opinion in favour of granting a marketing authorisation for a specific medicinal product. It results from the Committee's review of the documentation submitted by the applicant, and from subsequent discussions held during CHMP meetings. The EPAR is updated throughout the authorisation period as changes to the original terms and conditions of the authorisation (i.e. variations, pharmacovigilance issues, specific obligations) are made. EPARs also contain a summary written in a manner that is understandable to the public.
The summary, list of authorised presentations and the product information (SPC, labelling and package leaflet) for all authorised presentations are provided in all EU languages. The scientific discussion, procedural steps before authorisation and steps taken after authorisation are available in English only.Link for e-copy: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search. [...] Format of e-copy: Webpage Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=1435 Ethics and the pharmaceutical industry / Michael A. Santoro / Cambridge [U.K.] : Cambridge University Press (2007)
Ethics and the pharmaceutical industry [printed text] / Michael A. Santoro, Author ; Thomas M. Gorrie, Author . - Cambridge [U.K.] : Cambridge University Press, 2007 . - 492 p. : ill. ; 24 cm.
ISBN : 978-0-521-70888-3
Languages : English (eng)
Descriptors: Indexation
Drug Industry ; Ethics, Medical ; Pharmaceutical Preparations ; Research
Classification
HD 9665.5 Pharmaceutical IndustryAbstract: DescriptionContentsResourcesAbout the Authors
Despite the pharmaceutical industry's notable contributions to human progress, including the development of miracle drugs for treating cancer, AIDS, and heart disease, there is a growing tension between the industry and the public. Debates are raging over how the industry can and should be expected to act. In this volume leading figures in industry, government, NGOs, the medical community, and academia discuss and propose solutions to the ethical dilemmas of drug industry behavior. They examine such aspects as the role of intellectual property rights and patent protection, the moral and economic requisites of research and clinical trials, drug pricing, marketing and advertising. . Michael Santoro is Associate Professor with tenure in the Business Environment Department at Rutgers Business School, where he teaches courses on business ethics, public policy, labor and human rights, law, ethical issues in the pharmaceutical industry and China business strategy. As a Research Associate at Harvard Business School, he wrote or co-authored nearly thirty case studies and teaching notes on ethical and legal topics such as global protection of intellectual property, insider trading, the Federal Sentencing Guidelines and Fair Credit Reporting Act. Thomas Gorrie is Corporate Vice President, Government Affairs & Policy, at Johnson & Johnson, with responsiblity for all federal, state and international government affairs and policy. He completed post-doctoral studies at the Swiss Federal Institute of Technology in Zurich, following the receipt of his doctorate at Princeton University. Gorrie has over 30 years of worldwide health care experience and has worked with various Johnson & Johnson companies in research and development, marketing and sales, business development, strategic planning, general management, international, venture capital, and health policy.Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=3291 Hold
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Barcode Call number Media type Location Section Status 10273-02788 HD 9665.5 / SAN Book KCE Library (10.124) Available Readers who borrowed this document also borrowed:
Decision Modelling for Health Economic Evaluation Briggs, Andrew H. Gezondheidszorg in België Peers, Jan Les soins de santé en belgique Peers, Jan Evidence gaps for drugs and medical devices at market entry in Europe and potential solutions / Frank Hulstaert / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2021)
Evidence gaps for drugs and medical devices at market entry in Europe and potential solutions [printed text] / Frank Hulstaert, Author ; Céline Pouppez, Author ; Célia Primus-de Jong, Author ; Kathleen Harkin, Author ; Mattias Neyt , Author . - Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre, 2021 . - 221 p. : ill., ; A4. - (KCE Reports. Health Services Research (HSR); 347C) .
ISSN : D/2021/10.273/45 : € 0,00
Languages : English (eng)
Descriptors: Indexation
2019-08 ; Device Approval ; Drug Approval ; Pharmaceutical Preparations ; Prostheses and Implants ; R347 ; Technology Assessment, Biomedical
Classification
WB 102.5 Evidence-based practiceContents note: SCIENTIFIC REPORT 13 -- 1 INTRODUCTION, AIMS AND SCOPE OF THIS REPORT 13 -- 1.1 BACKGROUND 13 -- 1.2 THE REGULATORY SYSTEM OF MEDICINAL PRODUCTS AND MEDICAL DEVICES 17 -- 1.3 HEALTH TECHNOLOGY ASSESSMENT AND COVERAGE OF HEALTHCARE 17 -- 1.4 NEW EU REGULATIONS FOR MEDICAL DEVICES AND PHARMACEUTICALS 19 -- 1.5 AIMS AND SCOPE OF THIS PROJECT 20 -- 2 METHODS 22 -- 3 LEGAL AND ETHICAL CONSIDERATIONS 23 -- 3.1 INTRODUCTION: THE LEGAL AND ETHICAL FRAMEWORKS ON EVIDENCE REQUIREMENTS 23 -- 3.2 METHODOLOGY 24 -- 3.3 APPLICABLE RULES 25 -- 3.4 EVIDENTIARY REQUIREMENTS FOR MEDICINAL PRODUCTS AND MEDICAL DEVICES 28 -- 3.4.1 Ethical rules for the conduct of clinical trials 28 -- 3.4.2 Research and human rights 32 -- 3.4.3 Evidentiary requirements in the marketing authorisation process for medicines 33 -- 3.4.4 Evidentiary requirements in the CE-marking process for high-risk medical devices 47 -- 3.4.5 The role of ethics committees in reviewing the evidence and the Belgian situation 61 -- 3.5 TRANSPARENCY REQUIREMENTS FOR CLINICAL DATA 64 -- 3.5.1 Ethical rules regarding the transparency on clinical trials data 64 -- 3.5.2 Transparency requirements in the regulatory framework for medicines 65 -- 3.5.3 Transparency requirements for Medical devices 69 -- 3.5.4 Transparency of national reimbursement decisions 73 -- 3.5.5 Enforcement and penalties 73 -- 3.6 CONCLUSION / DISCUSSION REGARDING LEGAL FRAMEWORK 75 -- 4 ANALYSIS OF RIZIV-INAMI DOSSIERS 76 -- 4.1 METHODS 76 -- 4.2 FINDINGS 77 -- 4.2.1 Applications for reimbursement of 18 medicinal products 77 -- 4.2.2 Applications for reimbursement of 18 medical devices 81 -- 5 LITERATURE REVIEW 85 -- 5.1 METHODS 85 -- 5.1.1 Search strategy 85 -- 5.1.2 Selection procedure 86 -- 5.1.3 Selection criteria 87 -- 5.2 OVERVIEW OF THE LITERATURE ON MEDICINAL PRODUCTS 87 -- 5.2.1 Introduction 87 -- 5.2.2 Evidence gaps at market entry (and in the post-market period) 93 -- 5.2.3 Evidence gaps and reimbursement decisions 97 -- 5.2.4 Need for more collaboration (e.g. between regulators and HTA bodies) 98 -- 5.2.5 Use of surrogate endpoints 101 -- 5.2.6 Early patient access, conditional marketing authorisation and managed entry agreements 103 -- 5.3 OVERVIEW OF LITERATURE ON MEDICAL DEVICES 105 -- 5.3.1 Introduction 105 -- 5.3.2 The selected publications 109 -- 5.3.3 Recurring issues in the articles: 115 -- 6 DISCUSSION AND POSSIBLE SOLUTIONS 117 -- 6.1 THE TENSION BETWEEN BUSINESS PRIORITIES AND PATIENT BENEFIT 117 -- 6.1.1 The healthcare economy, important but not the scope of this project 117 -- 6.1.2 Hard law or ethical rules to manage business priorities versus patient benefit? 118 -- 6.1.3 The assessment of true innovation requires a direct comparison of patient benefit 119 -- 6.1.4 Horizon scanning and current limitations affecting the impact of early dialogue and common scientific advice 120 -- 6.1.5 The failed promise of post-marketing trials, coverage with evidence development and managed entry agreements 120 -- 6.2 TOWARDS A CLINICAL DEVELOPMENT PATHWAY THAT BETTER MEETS THE DEMANDS OF REGULATORS AND HTA BODIES 124 -- 6.2.1 The need for a better collaboration between regulators and HTA bodies 124 -- 6.2.2 The split between regulators and HTA bodies, an example of inefficient governance? 125 -- 6.3 EVIDENCE GAPS GROUPED ACCORDING TO THE PICOTS FRAMEWORK 125 -- 6.3.1 Population: keep the randomization but include the routine care patients, all evidence in patient subpopulations should be detailed 126 -- 6.3.2 Intervention: knowledge of optimal dose and duration is key, routine care to be reflected as much as possible 126 -- 6.3.3 The (active) comparator: the Helsinki declaration and the EMA 126 -- 6.3.4 Outcomes: focus on patient-relevant outcomes instead of surrogates that are not validated 128 -- 6.3.5 Study design and time periods, the opportunities and risks of relying only on observational real-world data 129 -- 6.3.6 Should the evidence bar be lower for medical devices? 133 -- 6.4 ON TRANSPARENCY AND REPORTING 135 -- 6.4.1 The case of medicinal products 135 -- 6.4.2 The case of medical devices 135 -- 6.5 PUBLISHED POLICY RECOMMENDATIONS 136 -- 7 RECOMMENDATIONS 139 -- 7.1 FOR THE EUROPEAN COMMISSION AND MEMBER STATES GOVERNMENTS 139 -- 7.2 FOR MEDICAL AND SURGICAL SCIENTIFIC SOCIETIES 140 -- 7.3 FOR (HIGH-RISK) MEDICAL DEVICE INDUSTRY 140 -- 7.4 FOR ALL ETHICS COMMITTEES IN BELGIUM AND ABROAD 141 -- 7.5 FOR ALL CONSUMER ORGANISATIONS AND PATIENT ORGANISATIONS 141 -- 7.6 TO RIZIV-INAMI, HTA AGENCIES AND PAYERS 141 -- 7.7 TO RIZIV-INAMI, INTERNATIONAL HTA AGENCIES, AND JOURNAL EDITORS 141 -- APPENDICES 142 Link for e-copy: https://doi.org/10.57598/R347C Format of e-copy: PDF (4,8 MB) Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=4802 Evidence gaps for drugs and medical devices at market entry in Europe and potential solutions / Frank Hulstaert / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2021)
Evidence gaps for drugs and medical devices at market entry in Europe and potential solutions : Synthese [printed text] / Frank Hulstaert, Author ; Céline Pouppez, Author ; Célia Primus-de Jong, Author ; Kathleen Harkin, Author ; Mattias Neyt , Author . - Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre, 2021 . - 38 p. : ill., ; A4. - (KCE Reports. Health Services Research (HSR); 347CS) .
ISSN : D/2021/10.273/44 : € 0,00
Languages : English (eng)
Descriptors: Indexation
2019-08 ; Device Approval ; Drug Approval ; Pharmaceutical Preparations ; Prostheses and Implants ; R347 ; Technology Assessment, Biomedical
Classification
WB 102.5 Evidence-based practiceContents note: SUMMARY 1 -- 1. INTRODUCTION, OBJECTIVE AND METHODOLOGY 3 -- 1.1. MARKET ACCESS IS REGULATED AT THE EUROPEAN LEVEL, WHILE REIMBURSEMENT IS DETERMINED BY THE MEMBER STATES. 3 -- 1.1.1. Medicinal products 4 -- 1.1.2. Medical devices 5 -- 1.1.3. Changes in the European regulations 5 -- 1.2. INITIATIVES THAT HAVE INCREASED THE EVIDENCE GAP AND INITIATIVES TO REDUCE THE EVIDENCE GAP 6 -- 1.3. OBJECTIVE OF THIS STUDY AND STUDY QUESTIONS 6 -- 2. ETHICAL AND LEGAL CONSIDERATIONS 9 -- 2.1. ETHICAL STANDARDS ON THE PROVISION OF EVIDENCE AND TRANSPARENCY 9 -- 2.2. EUROPEAN LEGISLATION ON MEDICINAL PRODUCTS 10 -- 2.2.1. Evidence requirements 10 -- 2.2.2. Procedure for the authorisation of clinical studies 10 -- 2.2.3. Transparency requirements 10 -- 2.3. EUROPEAN LEGISLATION ON MEDICAL DEVICES 10 -- 2.3.1. Evidence requirements 11 -- 2.3.2. Authorisation procedure for clinical research 11 -- 2.3.3. Transparency requirements 11 -- 2.4. EUROPEAN EVALUATION OF HEALTH TECHNOLOGY 12 -- 3. ANALYSIS OF THE INAMI/RIZIV DOSSIERS 12 -- 3.1.1. Results for the 18 assessment dossiers for medicinal products 13 -- 3.1.2. Results for the 18 assessment dossiers for medical devices 13 -- 4. LITERATURE STUDY 14 -- 4.1. MEDICINAL PRODUCTS 14 -- 4.2. MEDICAL DEVICES 15 -- 5. DISCUSSION AND POSSIBLE SOLUTIONS 16 -- 5.1. THE SEPARATION BETWEEN REGULATORY BODIES AND HTA BODIES; MORE COLLABORATION NECESSARY 16 -- 5.1.1. Study population requirements 19 -- 5.1.2. Requirements regarding the intervention 19 -- 5.1.3. Requirements regarding the comparator 19 -- 5.1.4. Requirements regarding outcomes 21 -- 5.1.5. Toward more efficient clinical studies; limitations of observational ‘real-world data’ 21 -- 5.1.6. Should the threshold of evidence for medical devices be lower? 22 -- 5.2. TRANSPARENCY REQUIREMENTS 23 -- 5.2.1. For medicinal products 23 -- 5.2.2. For medical devices 23 -- 5.3. PUBLISHED POLICY RECOMMENDATIONS 23 -- RECOMMENDATIONS 27 -- REFERENCES 32 Link for e-copy: https://doi.org/10.57598/R347CS Format of e-copy: PDF (2,48 MB) Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=4803 PermalinkFinancieringssystemen van ziekenhuisgeneesmiddelen / Nathalie Swartenbroekx / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2004)
PermalinkFormulaire des médicaments / Bruxelles [Belgique] : FOD Justitie = SPF Justice (2014)
PermalinkGeneesmiddelenformularium / Bruxelles [Belgique] : FOD Justitie = SPF Justice (2014)
PermalinkGuide pratique des médicaments génériques / Guillaume Janssens / Brussel [Belgium] : Hulpkas voor Ziekte- en Invaliditeitsverzekering (HZIV) / Caisse Auxiliaire d'Assurance Maladie - Invalidité (CAAMI) (2008)
PermalinkImpact of written drug information in patient package inserts. Acceptance and benefit/risk perception / Robert H. Vander Stichele / Ghent : University Ghent.Faculty of Medicine and Health Sciences. Heymans Institue of Pharmacology (2004)
PermalinkLe journal du médecin, 25(1483). Added Value Project / M Einhorn / Bruxelles : Cmpmedia (2003)
PermalinkLicences obligatoires pour les médicaments onéreux / Esther Van Zimmeren / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2022)
PermalinkPermalinkMarkttoegang in Europa voor geneesmiddelen en medische hulpmiddelen: gebrek aan bewijs en mogelijke oplossingen / Frank Hulstaert / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2021)
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