GLOBAL HARMONIZATION TASK FORCE (GHTF) --------- UPDATE: PLANNING THE 2012 ACTIVITIES Laurent Sellès DHoU SANCO B2 “Cosmetics and Medical Devices” CAMD.

Slides:

Advertisements

Similar presentations

EPAA Conference 5 November 2007 Georgette LALIS Enterprise and Industry DG European Commission The international dimension of regulatory acceptance.

Advertisements

GMDN Global Medical Device Nomenclature

Unique Device Identification

Health Products and Food Branch Direction générale des produits de santé et des aliments The Canadian Medical Devices Regulatory Program CESO Conference.

The European Association Medical devices

UDI and the GMDN (Global Medical Device Nomenclature)

EU Vigilance New Manufacturer Incident Report Form Piloting arrangements.

CE2012 Medical Device Regulatory Revision Austin Court, Birmingham 20th September 2012 Sponsored by.

Pearle conference 4-5 June 2010 Agenda point 14. Sector (civil soc.platf. / projects) OMCCACMinisters P

Revision of the Medical Device Directives The case of ‘Borderline’ Products used in a self-care context 48th AESGP Annual Meeting Nice, 6-8 June 2012 Laurent.

Slots/Windows of Opportunities HTA – Medical Devices Dr. Wolfgang Ecker EUnetHTA, Rome,

EDMA Page 1 EDMA Strategic Plan November 2002 John Place.

1 International/OECD Nanotechnology Activities EPA/DoD Meeting on Nanotechnology March 9, 2007 Jim Willis, EPA/OPPT.

1 Security-related internal market measures on explosives FEEM AGM, Brussels, 5 June 2013 Julian Foley Desk Officer – Civil explosives and pyrotechnic.

1 CONSENSUS STANDARDS OIVD WORKSHOP April 22-23, 2003 Rockville MD Ginette Y. Michaud, M.D. OIVD.

© EAAR 2012 Version 1, revised on Annual Report 2011.

The concept for a network of national Reference Laboratories for high risk IVDs – Results of the working group meeting 1.

Report on WG Clinical Investigation and Evaluation (CIE) Wolfgang Ecker Fed. Min. of Health, Austria Chairman CIE Cracow,

3rd ASAS TN Workshop 19 April – 21 April rd ASAS TN Workshop Session 4: Strategy and Implementation Package I Requirements Focus Group (“Rapid.

28th Meeting of the Competent Authorities Matthias Neumann Federal Ministry of Health, Germany Cracow, 27th of October 2011 Central Management Committee:

First ARGOS Workshop First ARGOS WORKSHOP (Barcelona, March 15, 2010) EHR Certification in EU Georges De Moor This project is funded.

Report from COEN CAMD Krakow 27 – 28 October 2011 Lars Johansson.

Session 5 – CA work program, results and ongoing work – Report from NBOG Rainer Edelhäuser Zentralstelle der Länder für Gesundheitsschutz bei.

New Rules for Clinical Investigations in Germany

Tokyo 10/11/2004 ATSEP training & license: the way forward.

Proposal for a Regulation of the European Parliament and of the Council on medical devices and amending Directive 2001/83/EC, Regulation (EC) No 178/2002.

GLOBAL HARMONIZATION TASK FORCE (GHTF) UPDATE: PLANNING THE 2012 ACTIVITIES Laurent Sellès DHoU SANCO B2 “Cosmetics and Medical Devices” CAMD.

Water.europa.eu 7-c) Expert Group & River Basins Network AGRICULTURE Strategic Co-ordination Group Brussels, May 2011 Nicolas Rouyer & Ville Keskisarja.

IMDRF VII National Competent Authority Report Exchange Programme Jean-François ROCHE DG GROWTH - Health Technology and Cosmetics Unit, European Commission.

The Joint ECE-Eurostat programme on the new recommendations for the 2010 round of Population and Housing Censuses in the ECE region Joint ECE-Eurostat.

Report from COEN CAMD Krakow 27 – 28 October 2011 Lars Johansson.

The use and administration of ICSMS in Sweden UNECE MARS meeting in Bratislava, 12 September 2012 Amina Makboul.

CIS-Workshop on „WFD and Hydropower“ June 2007 Berlin, Germany - First Workshop under Phase II ( ) of the EU activity „Water Framework Directive.

Resource-sharing amongst Member States in the field of vigilance and market surveillance 28th Meeting of the Competent Authorities for Medical Devices.

VICH General Principles and current update of VICH Outreach Forum activity 1.

-What is VICH, History and Objectives Hervé MARION, DVM VICH Secretariat.

Establishment of Medical Device GMP Requirements Hsiau-Wen Huang, Ph. D. Senior Researcher Bureau of Pharmaceutical Affairs Department of Health.

European Diagnostic Manufacturers Association EQA contribution and industry expectations Dr. Claude GIROUD – Chairman Standardization, Quality & Risk Management.

Slide 1 The contribution of a world-class regulatory environment to the future of the industry in Ireland Pat O’Mahony Chief Executive, Irish Medicines.

Activity Report and Future Planning. European thematic work 2006 Main priorities: 1.Gather and analyze "good practice" and general information on operations.

Workshop on conformity assessment procedures and certification of medical devices INT MARKT Kyiv, November 2011 Conformity assessment of medical.

Exchange of Letter on Medical Device -The Experience of Chinese Taipei Hsiau-Wen Huang, Ph. D. Senior Researcher Bureau of Pharmaceutical Affairs Department.

Health and Consumers Health and Consumers Introduction to the new Medical Device Regulations and their impact on medical software DG for Internal Market,

Director, Regulatory Affairs

Clusters working group COM/CAMD New Regulations

Update on EU regulatory developments

Industry Implementation Priorities & Challenges COM/CAMD Stakeholders meeting on the new MD and IVD Regulations 9 March, 2017 John Brennan Director.

Flowchart on overview of requirements

The European Association Medical devices

66 items – 70% of circulated products

Director, Asia Pacific Japan and U.S. Clinical Operations

Nicole Denjoy COCIR Secretary General

Michelle Limoli, Pharm.D.

11th GHTF CONFERENCE WASHINGTON DC OCTOBER 2007 SG5: CLINICAL EVALUATION STATUS REPORT SUSANNE LUDGATE Name MHRA Date 2007.

ERIC Experiences and New Developments

International Medical Device Regulatory Harmonization

“Association Presentation

Quality and Regulatory Planning – the way forward?

EA/CC Report Kevin Belson

Medical Device Design and Development

Larry Kessler, Sc.D. Director

Task Force – Cyber Security, Data Protection and Over-the-Air issues

The European Association Medical devices

The European Association Medical devices

Steering Committee, Eurostat, Luxembourg, 4 February 2011

Dr Manisha Shridhar Regional Advisor WHO-SEARO

Strategic Coordination Group 2007 Reporting Guidance on Monitoring

Item 4.2 – Towards the 2016 AES Philippe Lombardo Eurostat-F5

EUnetHTA Assembly May 2018.

Joint Action on Market Surveillance of medical devices (JAMS)

Presentation transcript:

GLOBAL HARMONIZATION TASK FORCE (GHTF) UPDATE: PLANNING THE 2012 ACTIVITIES Laurent Sellès DHoU SANCO B2 “Cosmetics and Medical Devices” CAMD Competent Authorities’ Meeting on Medical Devices

Global Harmonisation Task Force - Conceived in 1992, rotation of Chairmanship every 3 years - Purpose: international harmonization in MD regulations for safety, effectiveness, performance adequacy/quality of MDs - Publication of harmonized guidance docs on regulatory practices. - Guidance docs for adoption by Regulatory Authorities. - GHTF cooperates with Asian Harmonisation Working Party AHWP

May 2011 Europe’s participation in GHTF Steering Committee Laurent Sellès (COM) - Matthias Neumann (DE) Joanna Kilkowska (PL) – Jean-Claude Ghislain (FR) Benny Ons (EDMA) - François Simondet (EUROM VI) Jean-Yves Carentz (Eucomed) – Nicole Denjoy (COCIR) SG1 Premarket evaluation Chair [N. Shadeed (CAN)] P. Bischoff-Everding (COM) Alan Green (EUROM VI) Peter Linders (COCIR) _______________ SG1 Subgroup IVD Marie-Lise Migueres (FR) C é line Bourguignon (COM) Benny Ons (EDMA) Michael Thein (EDMA) Petra Kaars Wiele (EDMA) SG2 Post market surveillance /vigilance Chair Isabelle Demade (COM) Carmen Ruiz-Vilar (ES) Ekkehard St ö sslein (DE) Philippe Auclair (Eucomed) Bertram König (Eurom VI) SG3 Quality system Chair Egan Cobbold (CAN) Rainer Edelh ä user (DE) Carlos Arglebe (Cocir) Emmett Evereux (Eucomed) SG4 Auditing Chair Jan Welch (USA) Maintenance mode Peter Studer (CH) Philippe Lartigue (Cocir) Bertram Koenig (EuromVI) Fran ç ois Simondet ( EuromVI) Stefan Preiss (EU NB) John Worroll (EU NB) SG5 Clinical safety & Performance Chair S. Ludgate (UK) Wolfgang Ecker (AT) Isabel Scuntaro (CH) Benny Ons (EDMA) Christian Bailleul (Eucomed) Peter Rattke (COCIR) AHWG GMDN (Chair Rohan Hammett AUS) Susanne H ö ke (COM) AHWG “ UDI ” Chair: Laurent Sell è s (COM) Matthias Neumann (DE) Jesus Rueda (EDMA) Volker Zeinar(Eucomed) AHWG “ IAF ” (International Accreditation Forum) Chair: Roland Rotter/Egan Cobbold (CAN)

European coordination Information of progress of reflection: -MDEG (June, November 2010) and CA meetings (March, September 2010, February 2011) -Regular preparatory meetings prior to GHTF Steering Committee sessions (MS, Industry invited) In the Steering Committee, MS represented - by DE, NL, IT (in ) - by DE, IT, PL (in ) - by DE, PL, FR (in 2011)

STEERING COMMITTEE MEETING May 2011 BRISBANE At the Steering Committee (SC) meeting in Brisbane: - Japan (SC Chair) decided to : - cancel the SC meeting planned in October maintain the two SC meetings April and October will be for ‘closing the books’. -A conference could be part of an SC meeting and acknowledge the achievements of GHTF.

SG2 work programme  Finalize N111 on the def. & classification of FSCA.  Finalize N87 on the electronic transfer of AE data between MFRs, Authorised Reps and NCAs.  Publication of info on the SG2 NCARs Exchange Programme (incl. NCARs stats) on GHTF website. Prior to GHTF closure…

SG2-SG5 joint action Completion of the proposed guidance on AE reporting during pre-market clinical investigation. Also in 2012…

SG1-SG5 joint action Finalization of the proposed documents:  Clinical evidence for IVDs: key definitions & concepts.  Clinical evidence for IVDs: scientific validity determination and performance evaluation. Under development:  Clinical performance studies for IVDs. Also in 2012…