SEMINARIO
30 Octubre 2008
Barcelona 
| Seminario "Validación sistemas informatizados - 21CFR11" |
 9h30 Inscripción y recogida documentación - Café Bienvenida
10h Introducción Definiciones Normativa: Caso UE (ISO 13485) y USA (21CFR11)
Ejemplos no conformidades ISO 13485 y 483/EIR/warning letters CDRH FDA
¿Qué debe validarse y como?
Elaboración de Inventario
Guía GAMP 5
Programas de infraestructura
Programas no configurables (programas estándar)
Programas configurables
Programas a medida (custom)
Pasos validación. Guía GAMP 5 - guía validación software AAMI TIR 36
Documentación de la Validación. Directivas para su generación
Auditoria
Caso practico: validación hoja de cálculo
Caso practico: validación programa gestión producción
Coloquio y prueba de evaluación de aprovechamiento
19h Fin Jornada
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11 y 12 de Noviembre 2008
Frankfurt, GERMANY
| “Medical Device Risk Management Forum” |
SGS, que colabora con CSA, celebrará el 11 y 12 de Noviembre 2008 un “Medical Device Risk Management Forum”, en el Hotel Intercontinental, en Frankfurt, Alemania.
Health Canada ha establecido como fecha efectiva 15 de diciembre de 2008, para retirar la lista de normas reconocidas, actualizando a la 3era edición como norma reconocida (Recognized Standard)
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Inscripción Más información |
2 y 3 de Diciembre Barcelona
Inscripción www.medicaldevices-events.com | Jornada "Regulatory and ethical compliance for medical devices" |
El día 2 y 3 de diciembre, se celebrará en Barcelona la conferencia "Cumplimiento etico y reglamentario de los productos sanitarios" |
| Programa 1º dia - 2 Diciembre 2008 | | 08:30 | | Inscripcion | | 09:00 | Laurent Sellès
Deputy Head of Unit Cosmetics and Medical Devices DG Enterprise and Industry EUROPEAN COMMISSION | Opening remarks from the Chair
| | Reviewing the regulatory compliance perspective in Europe | | 09:10 | Laurent Sellès
Deputy Head of Unit Cosmetics and Medical Devices DG Enterprise and Industry EUROPEAN COMMISSION | Exploring the changes to Directive 2007/47/EC | | 09:50 | Luca Orlandini
MD, MFPM
Vice President Prof. Affairs SMITH & NEPHEW ORTHOPAEDICS | Considering the need for clinical evidence | | 10:30 | | Morning refreshments | | 10:50 | Dr Roland Prestel Clinical Affairs TÜV SÜD | Considering the need for clinical evidence | | Harmonising the regulatory framework for medical devices further | | 11:30 | Dr Margit Widmann
Head of Medical Device Division SWISSMEDIC | Assessing the likelihood of regulatory and ethical harmonisation | | 12:10 | | Lunch | | 13:30 | Christine Tarrajat
Director General EUROPEAN DIAGNOSTIC MANUFACTURERS ASSOCIATION (EDMA) | Outlining the achievements of the Global Harmonization Task Force (GHTF) | | Discussing ethical compliance in Europe and across | | 14:10 | Javad Seyedzadeh
Senior Vice President Global Quality Assurance
and Regulatory Affairs GAMBRO | Clarifying FDA guidelines for medical devices | | 14:50 | | Afternoon refreshments | | 15:10 | Karen Richards
Senior Director Integrity and Compliance
Vaccines and Diagnostics Division NOVARTIS | Establishing the effects of international misconduct on the European market | Highlighting the European perspective on ethical compliance | | 15:50 | Tamara Tubin
Associate Director Compliance EMEA ZIMMER | Ethics and compliance in Europe: challenges and opportunities | | 16:30 | | Closing remarks from the Chair and close of Day One |
| Programa 2º Dia - 3 Diciembre 2008 | | 08:30 | | Registration | | 09:00 | | Opening remarks from the Chair | | 09:10 | Roundtable morning sessions | Delegates will be able to attend three one-hour roundtable discussion groups from a selection of key topics. Each session will be chaired by an industry expert who will facilitate an exchange of opinions, essential experiences and learning related to a current aspect of regulatory and ethical compliance for medical devices. | | 1 | Debating approaches to consistent ethics frameworks
Laurent Sellès
Deputy Head of Unit Cosmetics and Medical Devices
DG Enterprise and Industry EUROPEAN COMMISSION | 2 | Discussing distributor and other third parties compliance with Foreign Corrupt Practices Act (FCPA) and anti-corruption law
Michelangelo Stefani, Esq.,
EMEA General Counsel COVIDIEN | 3 | Complying with Foreign Corrupt Practices Act (FCPA) requirements imposed on manufacturers with respect to their distributors: practical tips
Sylvain Poitras Assistant General Counsel International,
CARDINAL HEALTH | | | 4 | Establishing feasibility of Instructions for Use (IFUs) guidelines
Dr. Dirk Wetzel
Dr. Dirk WetzelHead of Division Medical Devices BFARM | 5 | Assessing barriers to corporate codes of conduct and how to handle them
R. Richard Boncy
Head of International Relations
VENTURA GARCES & LOPEZ - IBOR ABOGADOS | 6 | Optimising business process management to achieve global compliance
Dr.ir. Peter W.J. Linders
Director Standards Development Harmonisation Centre
PHILIPS HEALTHCARE | | | 7 | IVDs - Annex II List A products: revision of Common Technical Specifications (CTS) for performance evaluation and verification of manufactured products (batch release)
Christine Tarrajat Director General EDMA | | | | | |
| | 12:10 | | Lunch | | Establishing strategic and practical approaches for complying with the European and FDA regulatory frameworks | | 13:20 | Alexander Neumann
Vice President Corporate Legal Affairs
SORIN GROUP | Ensuring compliant healthcare professional and third party training | | 14:00 | R. Richard Boncy
Head of International Relations
VENTURA GARCES & LOPEZ - IBOR ABOGADOS | Codes of conduct for medical device companies | Clarifying regulatory uncertainties and establishing solutions | | 14:40 | Dr. Dirk Wetzel
Head of Division Medical Devices BFARM | IFUs for medical devices | | 15:20 | | Afternoon refreshments | | 15:40 | Ian Purdy
VP Regulatory Affairs Europe
BOSTON SCIENTIFIC | Explaining regulatory compliance for drug-device products | | 16;20 | Dr.ir. Peter W.J. Linders
Director Standards Development harmonisation Centre
PHILIPS HEALTHCARE | Outlining how processes can be amended to comply with the future regulatory framework | | 17:00 | | Closing remarks from the Chair and close of conference |
| POST-CONFERENCE WORKSHOP - 4 Diciembre 2008 | Understanding local / regional compliance requirements as part of a global compliance plan | | Date: | Thursday 4 December 2008 | | Led By: | Xavier Canals Riera
Director TECNO-MED INGENIEROS | Claire Murphy
Associate Consultant TECNO-MED INGENIEROS | About the workshop | The purpose of this workshop is to provide an overview of the issues to be considered when planning to market medical devices in the different regulatory arenas, including the EU, USA and Canada. Focusing on the EU, the workshop shall also include a review of the basic requirements of the EU Directives concerning medical devices and the different additional requirements arising from Member State national transpositions. It shall offer further insight into the local requirements that may be applicable when targeting particular regions and countries and suggests how to handle understanding and compliance with these requirements with a close look at the situation in Spain. | | Workshop Agenda | | 09:30 | Registration | 10:00 | Session 1: Getting medical devices to the market - Global compliance: is it possible? | 11:30 | Morning refreshments | 11:45 | Session 2: EU Directives concerning medical devices - A detailed look at the general community-wide requirements and the country-specific additions. | 13:15 | Lunch | 14:45 | Session 2 continued | 15:45 | Afternoon refreshments | 16:00 | Session 3: Local / regional requirements for medical devices - Case study: Spain and its 17 autonomous communities. | 18:00 | Close of workshop | | About your workshop leader: | Xavier Canals-Riera, Director, Eur Ing, has broad experience in medical device regulatory affairs and participates both in national regulatory and technical compliance events as well as imparting training at the UPC – Polytechnical University of Catalonia in Barcelona. With an academic background in telecommunications engineering he has specialised in healthcare and medical technology and is a technical expert for various European medical device Notified Bodies. Claire Murphy, Associate Consultant, B.E.(Elect.) also has an engineering background, specialising in software development and automated applications. At Tecno-med, she manages projects for quality management system compliance, process validation and US 510(k) submissions. As senior member of ASQ, she is a certified Biomedical Auditor and participates as speaker at the specialist training courses offered by Tecno-med to the medical device industry. Tecno-med Ingenieros provides regulatory support and expert advice to the medical device and health technology industry including manufacturers, importers and local distributors of medical devices as well as to healthcare centres and associated service providers. Our services are based on specific expertise in the technical and regulatory requirements of the three principal EU Directives concerning Medical Devices 93/42/EEC, In-vitro Diagnostics 98/79/EC and Active Implantable Medical Devices 90/385/EEC. |
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11 diciembre 2008
Barcelona
| Seminario "REQUISITOS MARCADO CE PRODUCTO SANITARIO" |
 9h30 Café bienvenida
10h Directiva 2007/47 revisión Directiva 93/42/EEC y 90/385/EEC
-Introducción.
-Directiva versus legislación nacional.
-Texto directivas revisado
Cambios Directiva 93/42/CEE (Real Decreto 414/1996) y Directiva 90/385/ CEE (RD 634/1993)
-Plazos de entrada en vigor de la Directiva.
11h -Requisitos ACTUALIZADOS de las directivas de productos sanitarios.
-¿es mi producto un producto sanitario? (software?)
-Clasificación productos sanitarios. (cambios en reglas) Nomenclatura
GMDN
-Requisitos de producto versus requisitos de instalaciones
-Marcado CE.
-Productos sanitarios sin marcado CE(investigación, a medida, in house)
-Rutas marcado CE: anexo II, V, ... (cambios segun dir.2007/47)
-Caso productos sin intervención de Organismo Notificado
-Documentación - Technical File. Normas armonizadas (STED 2008)
-Evaluación clínica (cambios segun dir.2007/47)
-Sistema de Gestión de la Calidad (ISO 13485:2003 vs ISO 9001:2000)
(nueva ISO 9001:2008)
-Gestión de riesgos ISO 14971:2007
-Validación de procesos
-Validación Sistemas Informatizados. Guia GAMP 5
-Sistema de vigilancia y seguimiento del mercado.MEDDEV 2.12.1 rev 5 -
2007 (entregamos nuevos formatos de comunicacion en word)
-Auditoria ON y AASS (¿qué me pedirán,
que miraran?)
-Conclusiones. Sumario
13h40 Coloquio - preguntas
14h Fin
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| Seminario licencias actividades de fabricación, importación y distribución de productos sanitarios |
Se celebro el 22 y 23 de septiembre de 2008 en Madrid y el 30 de septiembre en Barcelona la jormada sobre Licencias para las actividades de fabricación, importación y distribución de productos sanitarios.
Gran éxito de participación del sector en las jornadas que ha convocado AEFI que últimamente esta organizando numerosos actos retomando el protagonismo que un sector tan complejo como el de productos sanitarios merece. Enhorabuena a Elena Pedrazuela y a Mª Angeles Bravo sus representantes. Ponentes
D.ª M.ª Jesús Cantalapiedra. Consejera Técnica. Agencia Española del Medicamento y Productos Sanitarios.
D.ª Blanca Urosa . Inspectora. Consejería de Sanidad de la Comunidad de Madrid.
D.ª Rocío Domínguez. Inspectora. Consejería de Sanidad de la Comunidad de Madrid. D.ª Cristina Batlle. Responsable Area Funcional de Sanidad. Delegacion Gobierno Cataluña D. Salvador Cassany. Jefe Servicio Control F. y Productos Sanitarios. Consejería de Sanidad de la Comunidad de Cataluña Imágenes del seminario celebrado en Madrid que contó con la participación de más de 150 profesionales del sector. |
    
Mas Información |
Imágenes del seminario celebrado en Barcelona que contó con la participación de más de 200 profesionales del sector.      
Mas Información |
 | Nueva lista de normas armonizadas |
La Comisión Europea ha publicado una nueva lista de normas armonizadas para las directivas de productos sanitarios: |
  | Nueva edición de la EN 980:2008 |
Se ha publicado la nueva edición de la norma EN 980:2008. Ha sido armonizada en fecha 23/07/2008 (publicada en el DOUE)
La fecha límite para obtener presunción de conformidad respecto a la edición del 2003 es el 31/05/2010
Comprar norma |
SEMINARIO 
29 sep Madrid | Seminario CALIDAD UNE EN ISO 13485:2004 |
9h30 a 19h
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ver programa e inscripción Madrid |
16 Septiembre 2008 | Seminario Ensayos según UNE EN 60601-1:2008 |
SGS, que ensaya equipos médicos desde 1981 y que es además organismo notificado, celebrará el 16 de septiembre 2008 un Seminario sobre la nueva norma UNE-EN 60601-1 en sus laboratorios de la calle Trespaderne, 29 – 3ª planta, Edificio Barajas 1, Barrio del Aeropuerto, 28042 Madrid. 8h30 - 9h Recepción asistentes
9h -12h30 Comparativa nueva/antigua edición EN 60601-1 - Fernando Montes Director Tecnico Lab SGS
12h30-14h Análisis de riesgos aplicado a producto electromédico - Xavier Canals Director Tecno-med Ingenieros
14h - 15h comida
15h-17h Desviaciones nacionales Canada & USA de la norma IEC 60601-1 - Hans-Werner Zeller - Medical Devices Specialist CSA |
Programa curso | |
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