PRINCIPLES AND PRACTICES OF MEDICAL DEVICE DEVELOPMENT

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1 0 :: 2 v01 x y p.345 B xxx.:: B A x y pval«««[xy] -løøøø xxx.:: øøøø A PHARMATRAIN CENTRE OF EXCELLENCE PRINCIPLES AND PRACTICES OF MEDICAL DEVICE DEVELOPMENT Lisbon, INFARMED March 13-15, 2014 UC012

2 PRINCIPLES AND PRACTICES OF MEDICAL DEVICE DEVELOPMENT Face-to-face course: INFARMED, March 13-15, 2014 COLLABORATION MODULE LEADERS: Bruno Gago, PharmD, PhD Deputy Director, Training Programme in Pharmaceutical Medicine, Professor, Department of Health Sciences, University of Aveiro Judite Neves, PharmD Head of Health Products Directorate, INFARMED I.P. LECTURERS: (PROVISÓRIO) Ana Corrêa Nunes, MD Ana Pina Teixeira, Eng Ana Sofia Santos, PharmD Andreia Frade, Eng Antonieta Lucas, PharmD António Ornelas, MSc Bruno Gago, PharmD, PhD Catarina Simões, PharmD Cristina Coelho, MSc Eunice Lourenço, MSc Filipe Sousa, Eng Finn Borlum Kristensen MD, PhD Helena Dias, DVM José Malta, PharmD, MSc Judite Neves, PharmD Lília Louzeiro, DVM Luis Almeida, MD, PhD Luis Pereira Mariana Madureira, BSc Miguel Antunes, PharmD Nuno Morna, PharmD Raquel Alves, PharmD Sílvia Freitas, PharmD Sofia Prata, PhD Sónia Cardoso, BSc ORGANISATION: TRAINING PROGRAMME IN PHARMACEUTICAL MEDICINE A PharmaTrain CENTRE OF EXCELLENCE Director: Luis Almeida, MD, PhD Deputy Director: Bruno Gago, PharmD, PhD Associate Director: Miguel Forte, MD, PhD Department of Health Sciences University of Aveiro Aveiro Portugal Tel Fax

3 13 March 2014 DAY 01 10:00-10:15 WELCOME NOTE #01 INTRODUCTION TO MEDICAL DEVICE DEVELOPMENT & REGULATION (EUROPEAN REGULATORY REQUIREMENTS) 10:15-11:00 1. Peculiarities of a medical device: technologies, life-cycle, development, continuous improvement through iteration, market size, market growth, major players & competition Antonieta Lucas, PharmD (Regulatory Affairs Manager & Technical Director, Alcon; Ordem dos Farmacêuticos; APORMED) 11:00-11:45 2. Basis of the European regulatory requirements for Medical Devices #02 FUNDAMENTALS OF THE EUROPEAN MEDICAL DEVICE REGULATIONS 12:00-12:45 1. The definition and classification of medical devices & demarcation from other products Sónia Cardoso, BSc (Health Products Directorate, INFARMED I.P.) 12:45-13:30 2. Essential requirements, standards, ETCs and other guidances LUNCH #03 QUALITY MANAGEMENT SYSTEM CHAIRPERSON: 14:45-15:45 1. Systems to be implemented & applied for marketing & controlling Medical Devices: Quality management system (ISO 9001) and requirements for regulatory purposes (ISO 13485) Cristina Coelho, MSc (Quality Manager and Regulatory Affairs, Albino Dias de Andrade, Lda) 15:45-16:15 2. FDA quality system regulation #04 STRATEGY OF DEVELOPMENT OF MEDICAL DEVICES CHAIRPERSON: Antonieta Lucas, PharmD (Regulatory Affairs Manager & Technical Director, Alcon; Ordem dos Farmacêuticos; APORMED) 16:30-17:15 1. Innovation versus modification: development & design António Ornelas, MSc (Business Development & Innovation, BeyonDevices) 17:15-18:00 2. Non-clinical and clinical development in relation to product & type Bruno Gago, PharmD, PhD (Professor, University of Aveiro)

4 14 March 2014 DAY 02 #05 GENERATION OF CLINICAL EVIDENCE CHAIRPERSON: Lília Louzeiro, DVM (Team Manager for Medical Devices Area / Health Products Directorate, INFARMED I.P.) 09:00-09:40 1. Clinical data collection in relation to product & type observational studies & investigational clinical trials Bruno Gago, PharmD, PhD (Professor, University of Aveiro) 09:40-10:20 2. Post- marketing surveillance plan including post-marketing clinical follow-up Catarina Simões, PharmD (Regulatory and Quality Department, Medtronic) 10:20-11:00 3. ISO (GCP for medical devices) Ana Corrêa Nunes, MD (Medical Assessor, Scientific Evaluation Unit / Medicines Evaluation Committee, INFARMED I.P.) #06 BENEFIT/ RISK ASSESSMENT CHAIRPERSON: Sónia Cardoso, BSc (Health Products Directorate, INFARMED I.P.) 11:15-11:45 1. Safety and performance assessment José Malta, PharmD, MSc (Product Development Coordinator, NUTRI.ADD / Grupo LABIALFARMA) 11:45-12:15 2. Technical dossier & application for CE mark according to class Ana Pina Teixeira, Eng (Executive Director, SGS Portugal) LUNCH 13:30-14:00 3. The role of Notified Bodies, Accreditation Bodies & Competent Authorities 14:00-14:45 4. Clinical evaluation Lília Louzeiro, DVM (Team Manager for Medical Devices Area / Health Products Directorate, INFARMED I.P.) #07 NEW AND EMERGING TECHNOLOGIES CHAIRPERSON: Luis Almeida, MD, PhD (Professor, University of Aveiro; Managing Partner, Blueclinical Ltd; CEO, Luzitin SA) 14:45-15:15 1. New and emerging technologies Mariana Madureira, BSc (Adviser to the Executive Board, INFARMED I.P.) 15:15-15:45 2. New generation of products related to interventional cardiology Luis Pereira (Country Manager, Medtronic) & Catarina Simões, PharmD (Regulatory and Quality Department, Medtronic) 15:45-16:30 3. Reality of the portuguese medical devices market Andreia Frade, Eng. (Manager, Critical Health S.A.) & ßßFilipe Sousa, Eng. (Research, Fraunhofer Portugal Research Center) #08 CASE STUDIES CHAIRPERSON: Luis Almeida, MD, PhD (Professor, University of Aveiro; Managing Partner, Blueclinical Ltd; CEO, Luzitin SA) 16:45-18:00 1. Exercises of classification & demarcation of products Sónia Cardoso, BSc Ana Sofia Santos, PharmD Helena Dias, DVM (Health Products Directorate, INFARMED I.P.) 2. Exercises on clinical investigation notification Lília Louzeiro, DVM Eunice Lourenço, MSc (Health Products Directorate, INFARMED I.P.)

5 #09 15 March 2014 DAY 03 HEALTH TECHNOLOGY ASSESSMENT 09:00-09:45 1. Health Technology Assessment (HTA) Finn Borlum Kristensen MD, PhD (Chairman of the Executive Committee, European Network for HTA; Director of the Coordinating Secretariat of EUnetHTA Joint Action, National Board of Health, Denmark) 09:45-10:30 2. Assessment (HTA) & appraisal Miguel Antunes, PharmD (Health Technology Assessment, INFARMED I.P.) #10 REGULATORY REQUIREMENTS FOR MEDICAL DEVICES OUTSIDE EUROPE CHAIRPERSON: Raquel Alves, PharmD (Director of Health Products Vigilance Unit / Health Products Directorate, INFARMED I.P.) 10:30-11:15 1. Global approaches: US, Japan and rest of the World Luis Pereira (Country Manager, Medtronic) 11:15-11:45 2. GHTF/IMDRF & subgroups #11 CASE STUDIES CHAIRPERSON: Lília Louzeiro, DVM (Team Manager for Medical Devices Area / Health Products Directorate, INFARMED I.P.) 12:00-12:45 1. Compilation of a Technical dossier Silvia Freitas, PharmD (Regulatory Affairs Director, Laboratórios Edol) 12:45-13:30 2. Compilation of clinical data (for clinical evaluation) Sofia Prata, PhD (Technical Director, Ceramed) LUNCH #12 SAFETY OF MEDICAL DEVICES, VIGILANCE SYSTEMS FOR MEDICAL DEVICES 15:00-15:45 1. EU vigilance guidelines & their national implementation Raquel Alves, PharmD (Director of Health Products Vigilance Unit / Health Products Directorate, INFARMED I.P.) 15:45-16:15 2. Vigilance process Raquel Alves, PharmD (Director of Health Products Vigilance Unit / Health Products Directorate, INFARMED I.P.) 16:15-17:00 3. Assessment of benefit/risk balance of medical devices Catarina Simões, PharmD (Regulatory and Quality Department, Medtronic) #13 CASE STUDIES 17:00-17:45 1. Training of vigilance reporting on Medical Devices Raquel Alves, PharmD Nuno Morna, PharmD (Health Products Vigilance Unit / Health Products Directorate, INFARMED I.P.) 17:45-18:00 CLOSING NOTE Bruno Gago, PharmD, PhD (Professor, University of Aveiro)

6 PRINCIPLES AND PRACTICES OF MEDICAL DEVICE DEVELOPMENT This module is a mandatory part of the curricular unit Principles and Practices of Medical Device Development. To achieve the curricular unit objectives and learning outcomes the participant should complement module participation with other planned learning modalities, including a variety of written assignments. Curricular unit learning outcomes: On successful completion of this Module the participant should be able to: 1. Describe and define the field of medical devices, the distinguishing features of medical device technologies, industries and regulatory framework as compared to medicinal products. 2. Interpret the conformity assessment of medical devices based on essential requirements. 3. Categorise medical device products according to the relevant classification and demarcation principles. 4. Describe and illustrate non-clinical and clinical development of medical devices, standardisation and use of standards: European standards, national standards, ISO/IEC standards and harmonised standards. Quality management. 5. Appraise the vigilance and risk management programmes for medical devices. 6. Interpret the principles underlying the compilation of technical dossier/design dossier. 7. Appraise the combined pharmaceutical, clinical pharmacological and technological requirements for the development of medicine-medical device combinations. 8. Evaluate the need and requirements for the joint development of targeted medicine therapy and the related companion diagnostics. 9. Assess the medical needs and clinical significance of emerging technologies. 10. Estimate the requirements for the Health Technology Assessment of medical devices. Course Project Manager: Anabela Farrica, BSc (Master Student; ENDORSEMENT EXTERNAL ACCREDITATION

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