ATMP GMP requirements. Andrew Hopkins
|
|
- Luke Davidson
- 5 years ago
- Views:
Transcription
1 Andrew Hopkins
2 Scope GMP for ATMPs Points to consider Survey MHRA next steps Questions 2
3 GMP for ATMPs The usual process for GMP updates Problem statement submitted to IWG and PIC/S Reviewed and if accepted drafting Working Group set up with clear objective and mandate Draft prepared and submitted to PIC/S and IWG for consideration Issued for public consultation Comments reviewed and decisions recorded and justified Update document published with 6 month implementation 3
4 The process for GMP for ATMPs First draft seen in September 2016 Draft prepared by CAT and Commission Prepared as a response to a perceived problem Initially input from inspectors was limited Public consultation occurred Inspectors asked to participate in 2 weekly TCs Rewrite resulted in bigger document Public consultation Published in December to 2017 with implementation May
5 Scope GMP for ATMPs Points to consider Survey MHRA next steps Questions 5
6 Points to consider Process did not involve agencies outside of EU Document disconnects from part 1 of EU GMP Current part 1 built on (bad) experiences Not clear what the maintenance system is Wholesale cut and paste of much of the GMPs in part 1 6
7 Points to consider (the details) The new guidance does cover some areas that are specific to ATMPS and in this respect is beneficial 7
8 Points to consider(the details) 1.11 article 5 mandates a separate GMP 1.12 Not sure that NCAs can be told not to add to regs requirements Appears to give more flexibility, but in doing so also gives less clarity Difficult for manufacturers Difficult for inspectors May need more interpretive documents to support the new GMP 8
9 Points to consider (the details) Some general issues that may cause interpretational difficulties: Structure may not be logical, for instance guidance on sterile facilities appears in a number of sections Section 17 on automated processes 9
10 Points to consider (the details) Some general issues that may cause interpretational problems: Some statements give flexibility but do not give clarity e.g: seems to give hospitals and academia room to not have an effective PQS 2.2 Specifies a Risk based approach, but not really giving guidance on what this looks like 2.25 Allows flexibility if agreed in the MA, including facilities and equipment Question: If agreed in an MA can a deficiency be cited in an inspection? 2.50 Allow flexibility of manufacture of early stage trials in A with C background in exceptional circumstances Question: What do you think exceptional circumstances are? 10
11 Points to consider (the details) Some general issues that may cause interpretational problems: Some elements currently covered by part 1 not captured: Notable example is Annex 11 So without the link to part 1 what are the expectations 11
12 Scope GMP for ATMPs Points to consider Survey MHRA next steps Questions 12
13 Survey Why do it Are there problems? If so what are they Without clearly defining any problems we cannot offer an effective fix What are you looking for: Evidence of GMPS being prohibitive to innovation Any items considered to be over the top in existing GMPS Any thing lacking in existing GMPS Elements that help in the new GMPS Anything that is not so good in new GMPS 13
14 Scope GMP for ATMPs Points to consider Survey MHRA next steps Questions 14
15 MHRA next steps Complete/close out survey Compile Reponses Assess responses Publish results and our proposed responses Publish our intended approach to inspection going forward Work with PIC/S 15
16 MHRA next steps (story so far) Received some responses back (just into double figures?) Need more Nature of feedback: Generally agreeing that the new GMP needs further consideration for inspection etc. Some quite specific topics e.g. more guidance on release of OOS materials Some verbal feedback regarding smaller manufacturers welcome flexibility Need more feedback, it is an important issues and we (MHRA and industry) need and want to get it right. 16
17 Thank you for listening Any questions? 17
18 Contact Andrew Hopkins Expert GMDP Inspector Complete our Innovation Office enquiry form or send an to 18
19 Crown copyright 2017 About copyright All material created by the Medicines and Healthcare Products Regulatory Agency, including materials featured within these Medicines and Healthcare Products Regulatory Agency presentation notes and delegate pack, is subject to Crown copyright protection. We control the copyright to our work (which includes all information, database rights, logos and visual images), under a delegation of authority from the Controller of Her Majesty s Stationery Office (HMSO). The Medicines and Healthcare Products Regulatory Agency authorises you to make one free copy, by downloading to printer or to electronic, magnetic or optical storage media, of these presentations for the purposes of private research, study and reference. Any other copy or use of Crown copyright materials featured on this site, in any form or medium is subject to the prior approval of the Medicines and Healthcare products Regulatory Agency. Further information, including an application form for requests to reproduce our material can be found at Material from other organisations The permission to reproduce Crown copyright protected material does not extend to any material in this pack which is subject to a separate licence or is the copyright of a third party. Authorisation to reproduce such material must be obtained from the copyright holders concerned. 19
Health Based Exposure Limits (HBEL) and Q&As
Health Based Exposure Limits (HBEL) and Q&As The EMA guideline (EMA/CHMP/ CVMP/ SWP/169430/2012) & EMA/CHMP/CVMP/SWP/463311/2016 Graeme McKilligan, UK, MHRA. Content Intent of HBEL Post Implementation
More informationICH Q10 Pharmaceutical Quality System
Safeguarding public health ICH Q10 Pharmaceutical Quality System An EU Regulator s Perspective Presentation overview Why does Q10 exist and what were the desired outcomes Content of the Q10 step 2 document
More informationMedical Devices cyber risks and threats
Medical Devices cyber risks and threats David Grainger Senior Medical Device Specialist MHRA The challenges of software medical device regulation. david.grainger@mhra.gov.uk Current framework 1998 In Vitro
More informationImpact of ICH Q9 and the application of Risk Management
Safeguarding public health Impact of ICH Q9 and the application of Risk Management An inspector s perspective on the impact on inspectional approaches and expectations Ian Thrussell Strategy and Development
More informationClaus Mortensen, Medicines Inspector. Danish Medicines Agency. Member of the EMEA PAT team
Claus Mortensen, Medicines Inspector Danish Medicines Agency Member of the EMEA PAT team EMEA progress and status what is needed to document scientific understanding in a PAT application EMEA PAT team
More informationAnnual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2017
17 July 2018 EMA/INS/GMP/19273/2018 Committees and Inspections Annual report of the Good Manufacturing and Distribution Practice Inspectors Working 30 Churchill Place Canary Wharf London E14 5EU United
More informationOffice for Nuclear Regulation
Office for Nuclear Regulation Redgrave Court Merton Road Bootle Merseyside L20 7HS www.hse.gov.uk/nuclear PROJECT ASSESSMENT REPORT Report Identifier: ONR-Policy-all-PAR-11-001 Revision: 2 Project: Implementation
More informationMA/INS/GMP/735037/2014 Annex 1 of the GMP Guidelines on Good Manufacturing Practice - Manufacture of Sterile Medicinal Products
31 March, 2015 European Medicines Agency GMP/GDP Inspectors Working Group (GMP/GDP IWG) 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Subject: MA/INS/GMP/735037/2014 Annex 1 of the GMP
More informationJustice Select Committee: Inquiry on EU Data Protection Framework Proposals
Justice Select Committee: Inquiry on EU Data Protection Framework Proposals Response by the Wellcome Trust KEY POINTS The Government must make the protection of research one of their priorities in negotiations
More informationSHTG primary submission process
Meeting date: 24 April 2014 Agenda item: 8 Paper number: SHTG 14-16 Title: Purpose: SHTG primary submission process FOR INFORMATION Background The purpose of this paper is to update SHTG members on developments
More informationAustralian Technical Specification
ATS 4747.1 2008 ATS 4747.1 2008 Australian Technical Specification Meters for non-urban water supply Part 1: Glossary of terms This Australian Technical Specification was prepared by Committee CE-024,
More informationETSI EN V1.5.1 ( ) Harmonized European Standard (Telecommunications series)
EN 300 330-2 V1.5.1 (2010-02) Harmonized European Standard (Telecommunications series) Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Radio equipment in the
More informationPharmacovigilance Inspection Metrics Report
April 2013 - March 2014 Pharmacovigilance Inspection Metrics Report Introduction During the period 01 April 2013 to 31 March 2014, the Pharmacovigilance inspectorate conducted 56 inspections of Marketing
More informationWhat We Heard Report Inspection Modernization: The Case for Change Consultation from June 1 to July 31, 2012
What We Heard Report Inspection Modernization: The Case for Change Consultation from June 1 to July 31, 2012 What We Heard Report: The Case for Change 1 Report of What We Heard: The Case for Change Consultation
More informationThis document is a preview generated by EVS
TECHNICAL REPORT IEC/TR 80002-1 Edition 1.0 2009-09 colour inside Medical device software Part 1: Guidance on the application of ISO 14971 to medical device software IEC/TR 80002-1:2009(E) THIS PUBLICATION
More informationAustralian Standard. High-voltage test techniques. Part 3: Definitions and requirements for on-site testing AS IEC , Ed.
AS 60060.3 2008 IEC 60060-3, Ed. 1 (2006) AS 60060.3 2008 Australian Standard High-voltage test techniques Part 3: Definitions and requirements for on-site testing This Australian Standard was prepared
More informationChief Nuclear Inspector s Inspection of NNB GenCo Ltd. s Supply Chain Management Arrangements for the Hinkley Point C Project
Chief Nuclear Inspector s Inspection of NNB GenCo Ltd. s Supply Chain Management Arrangements for the Hinkley Point C Project 15 March 2018 Chief Nuclear Inspector s Inspection of NNB GenCo Ltd. s Supply
More informationETSI EN V1.1.2 ( ) Harmonized European Standard
EN 302 729-2 V1.1.2 (2011-05) Harmonized European Standard Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Level Probing Radar (LPR) equipment operating in the
More informationTriennial Review of the Medicines and Healthcare Products Regulatory Agency. Call for Evidence
Triennial Review of the Medicines and Healthcare Products Regulatory Agency Call for Evidence Title: Triennial Review of the Medicines and Healthcare Products Regulatory Agency Call for Evidence Author:
More informationAustralian Standard. Electricity metering equipment (AC) Particular requirements
AS 62053.21 2005 AS 62053.21 2005 Australian Standard Electricity metering equipment (AC) Particular requirements Part 21: Static meters for active energy (classes 1 and 2) (IEC 62053-21, Ed.1.0 (2003)
More informationISO INTERNATIONAL STANDARD
INTERNATIONAL STANDARD ISO 15223-1 Second edition 2012-07-01 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements Dispositifs
More informationAustralian Standard. Design review AS IEC IEC 61160, Ed.2 (2005) AS IEC
AS IEC 61160 2008 IEC 61160, Ed.2 (2005) AS IEC 61160 2008 Australian Standard Design review This Australian Standard was prepared by Committee QR-005, Dependability. It was approved on behalf of the Council
More informationEU, USA and Japan (II) Reports from Regulators on Exchange Assignments
EU, USA and Japan (II) Reports from Regulators on Exchange Assignments Yoshikazu Hayashi MHLW/PMDA Liaison at EMA PMDA 24th Annual EuroMeeting 26-28 March 2012 Copenhagen, Denmark Disclaimer The views
More informationRecast de la législation européenne et impact sur l organisation hospitalière
Recast de la législation européenne et impact sur l organisation hospitalière MEDICAL DEVICES IN BELGIUM. What s up? Brussels44Center 24.10.2017 Valérie Nys Need for changes? Regulatory system is highly
More informationJustin McCarthy John Amoore, Paul Blackett, Fran Hegarty, Richard Scott. Regulations, Guidance and Standards
Justin McCarthy John Amoore, Paul Blackett, Fran Hegarty, Richard Scott Regulations, Guidance and Standards 1 What s it all about? Clarity regarding the difference between: Regulations Guidance Standards
More informationKEY HIGHLIGHTS WORKSHOP 2019
KEY HIGHLIGHTS aenvironmental Monitoring afacility Design apractical Case Studies avisual Inspection aclean Room Behaviours aprocess Simulations arecent 483s, warning Letters and EU Observations WORKSHOP
More informationEU GMP Evolution or Revolution Scope and drivers for EU GMP changes. August Gordon Farquharson
EU GMP Evolution or Revolution Scope and drivers for EU GMP changes August 2015 Gordon Farquharson EU & PIC/S Harmonisation at IWG level now Slide 2 PharmOut 2015 EU & PIC/S Harmonisation (1) What does
More informationManufacture of medicinal products in Italy: challenges for the Italian Medicines Agency
Manufacture of medicinal products in Italy: challenges for the Italian Medicines Agency Isabella Marta Coordinator Inspections and Certification Dept. Head Manufacturing Authorization Office Italian Medicines
More informationMinistry of Justice: Call for Evidence on EU Data Protection Proposals
Ministry of Justice: Call for Evidence on EU Data Protection Proposals Response by the Wellcome Trust KEY POINTS It is essential that Article 83 and associated derogations are maintained as the Regulation
More informationWylfa Nuclear Power Station
Wylfa Nuclear Power Station Environmental Statement Pre-Application Opinion. February 2013 Crown copyright 2011 First published February 2013 You may reuse this information (excluding logos) free of charge
More informationQuality assurance in the supply chain for pharmaceuticals from the WHO perspective
1 Quality assurance in the supply chain for pharmaceuticals from the WHO perspective Dr Sabine Kopp Quality Assurance and Safety: Medicines Medicines Policy and Standards World Health Organization Presentation
More informationInter-Association Task Force
Inter-Association Task Force Presentation to EMA Workshop Prevention of Drug Shortages Based on Quality and Manufacturing Issues 9 th October 2015 1 Topics for Today Background and history of task force
More informationFinal draft ETSI EN V1.3.1 ( )
Final draft EN 300 433-2 V1.3.1 (2011-05) Harmonized European Standard Electromagnetic compatibility and Radio spectrum Matters (ERM); Citizens' Band (CB) radio equipment; Part 2: Harmonized EN covering
More informationThe Cremation (Scotland) Regulations Consultation. Introduction. The regulations
The Cremation (Scotland) Regulations 2017 Consultation Introduction 1. The Burial and Cremation (Scotland) Act 2016 1 provides a modern, comprehensive legislative framework for burial and cremation. The
More informationAS/NZS :2017. Electrical installations Selection of cables AS/NZS :2017
Australian/New Zealand Standard Electrical installations Selection of cables AS/NZS 3008.1.1:2017 Part 1.1: Cables for alternating voltages up to and including 0.6/1 kv Typical Australian installation
More informationENCePP Work Plan
EMA/231507/2012 ENCePP Secretariat European Network of Centres for Pharmacoepidemiology and Pharmacovigilance European Network of Centres for Pharmacoepidemiology and Pharmacovigilance Adopted by the ENCePP
More informationETSI EN V1.3.1 ( )
EN 300 422-2 V1.3.1 (2011-08) Harmonized European Standard Electromagnetic compatibility and Radio spectrum Matters (ERM); Wireless microphones in the 25 MHz to 3 GHz frequency range; Part 2: Harmonized
More informationETSI EN V1.2.1 ( ) Harmonized European Standard
EN 302 372-2 V1.2.1 (2011-02) Harmonized European Standard Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Equipment for Detection and Movement; Tanks Level Probing
More informationAustralian/New Zealand Standard
AS/NZS 4114.2 Australian/New Zealand Standard Spray painting booths, designated spray painting areas and paint mixing rooms Part 2: Installation and maintenance This Joint Australian/New Zealand Standard
More informationParenteral Nutrition Down Under Inc. (PNDU) Working with Pharmaceutical Companies Policy (Policy)
Parenteral Nutrition Down Under Inc. (PNDU) Working with Pharmaceutical Companies Policy (Policy) BACKGROUND (Reason or Purpose) The purpose of this Policy is to provide clear principles and guidance about
More informationIssues in Emerging Health Technologies Bulletin Process
Issues in Emerging Health Technologies Bulletin Process Updated: April 2015 Version 1.0 REVISION HISTORY Periodically, this document will be revised as part of ongoing process improvement activities. The
More informationCurrent Status and Challenges of Bilateral/Multilateral Meetings
Current Status and Challenges of Bilateral/Multilateral Meetings Junko Sato, PhD International Liaison Officer PMDA 26th Annual EuroMeeting 25-27 March 2014 ACV, Vienna Austria Disclaimer The views and
More informationThis is a preview - click here to buy the full publication
IEC/TR 80002-1 TECHNICAL REPORT Edition 1.0 2009-09 colour inside Medical device software Part 1: Guidance on the application of ISO 14971 to medical device software INTERNATIONAL ELECTROTECHNICAL COMMISSION
More informationETSI EN V1.2.1 ( ) Harmonized European Standard (Telecommunications series)
EN 300 086-2 V1.2.1 (2008-09) Harmonized European Standard (Telecommunications series) Electromagnetic compatibility and Radio spectrum Matters (ERM); Land Mobile Service; Radio equipment with an internal
More informationFinal draft ETSI EN V1.1.1 ( )
Final draft EN 302 291-2 V1.1.1 (2005-05) Candidate Harmonized European Standard (Telecommunications series) Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Close
More informationAt its meeting on 18 May 2016, the Permanent Representatives Committee noted the unanimous agreement on the above conclusions.
Council of the European Union Brussels, 19 May 2016 (OR. en) 9008/16 NOTE CULT 42 AUDIO 61 DIGIT 52 TELECOM 83 PI 58 From: Permanent Representatives Committee (Part 1) To: Council No. prev. doc.: 8460/16
More informationCEN / CENELEC Joint Task Force, Software as Medical Devices: Current Status
CEN / CENELEC Joint Task Force, Software as Medical Devices: Current Status JIC Open Forum - Software as Medical Devices Educational session, Melvin Reynolds at ISO/TC215 and CEN/TC 251 JWGs meeting Rotterdam,
More informationDoing, supporting and using public health research. The Public Health England strategy for research, development and innovation
Doing, supporting and using public health research The Public Health England strategy for research, development and innovation Draft - for consultation only About Public Health England Public Health England
More informationAS/NZS 1200:2000 AS/NZS
AS/NZS 1200:2015 Australian/New Zealand Standard Pressure equipment Superseding AS/NZS 1200:2000 AS/NZS 1200:2015 AS/NZS 1200:2015 This joint Australian/New Zealand standard was prepared by joint Technical
More informationEast Anglia TWO and East Anglia ONE North. Summary and Approach to Site Selection
East Anglia TWO and East Anglia ONE North Summary and Approach to Site Selection 1 Introduction ScottishPower Renewables (SPR) has recently concluded work in order to inform our onshore site selection
More informationRoad signs Specifications
AS 1743:2018 AS 1743:2018 Road signs Specifications This Australian Standard was prepared by Committee MS-012, Road Signs and Traffic Signals. It was approved on behalf of the Council of Standards Australia
More informationETSI EN V2.1.1 ( ) Harmonized European Standard (Telecommunications series)
EN 302 500-2 V2.1.1 (2010-10) Harmonized European Standard (Telecommunications series) Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD) using Ultra WideBand (UWB)
More informationEDQM COUNCIL OF EUROPE CONFERENCE CERTIFICATION PROCEDURE : 20 YEARS OF EXPERIENCE March EDQM, Strasbourg, France ABSTRACTS
EDQM COUNCIL OF EUROPE CONFERENCE CERTIFICATION PROCEDURE 1992-2012: 20 YEARS OF EXPERIENCE 22-23 March 2012 EDQM, Strasbourg, France ABSTRACTS PLENARY SESSION, 22 March 2012 ABSTRACT 1.3 The Evolution
More informationGCSE Subject Level Guidance for Computer Science May 2015
GCSE Subject Level Guidance for Computer Science May 2015 Ofqual/15/5682 Contents Introduction... 2 Guidance set out in this document... 3 Guidance on assessment objectives for GCSE Qualifications in Computer
More informationProcedure for introducing current scientific and technical knowledge into the authorisation procedure for plant protection products
Procedure for introducing current scientific and technical knowledge into the authorisation procedure for plant protection products Contact address: Bundesamt für Verbraucherschutz und Lebensmittelsicherheit
More informationICH Q8, 9 & 10 and the Impact on the QP
1 ICH Q8, 9 & 10 and the Impact on the QP Peter H. Gough David Begg Associates phg@david-begg-associates.com 2 A New Approach to Regulation Approach to the regulation of pharmaceuticals is undergoing a
More informationGuide to the Requirements for Public Information and Disclosure GD-99.3
Guide to the Requirements for Public Information and Disclosure GD-99.3 November 2010 Guide to the Requirements for Public Information and Disclosure Guidance Document GD-99.3 Minister of Public Works
More informationCOMMISSION DELEGATED DIRECTIVE (EU).../ of XXX
EUROPEAN COMMISSION Brussels, XXX [ ](2016) XXX draft COMMISSION DELEGATED DIRECTIVE (EU).../ of XXX amending, for the purposes of adapting to technical progress, Annex III to Directive 2011/65/EU of the
More informationUser Guide Mining Hazard (not including coal) in Great Britain v1.
User Guide Mining Hazard (not including coal) in Great Britain v1. Contents 1 Introductory Information 1.1 Introduction 1.2 Mining Hazard (not including coal) in Great Britain 2 Technical Information &
More informationPublic Information and Disclosure RD/GD-99.3
Public Information and Disclosure RD/GD-99.3 March, 2012 Public Information and Disclosure Regulatory Document RD/GD-99.3 Minister of Public Works and Government Services Canada 2012 Catalogue number CC172-82/2012E-PDF
More informationETSI TR V1.2.1 ( )
TR 100 392-17-3 V1.2.1 (2006-06) Technical Report Terrestrial Trunked Radio (TETRA); Voice plus Data (V+D); Part 17: TETRA V+D and DMO specifications; Sub-part 3: Release 1.3 2 TR 100 392-17-3 V1.2.1 (2006-06)
More informationOctober 31, Office of the Secretary Consumer Product Safety Commission Room East West highway Bethesda, MD 20814
October 31, 2008 Office of the Secretary Consumer Product Safety Commission Room 502 4330 East West highway Bethesda, MD 20814 Subject: Consumer Product Safety Improvement Act; Section 101: Children s
More informationETSI EN V1.4.1 ( )
EN 300 422-2 V1.4.1 (2015-06) HARMONIZED EUROPEAN STANDARD Electromagnetic compatibility and Radio spectrum Matters (ERM); Wireless microphones in the 25 MHz to 3 GHz frequency range; Part 2: Harmonized
More informationGE/GN8648. Guidance on Positioning of Lineside Telephones. Rail Industry Guidance Note for GE/RT8048
GN This document contains one or more pages which contain colour. Published by: Block 2 Angel Square 1 Torrens Street London EC1V 1NY Copyright 2013 Rail Safety and Standards Board Limited GE/GN8648 Issue
More informationONR perspectives on design assessment and licensing of SMRs
ONR perspectives on design assessment and licensing of SMRs Nuclear Institute June 2016 Craig Reiersen Head of New Reactor Licensing Office for Nuclear Regulation Ana Gomez-Cobo New Reactor Safety Case
More informationNEMA XR X-ray Equipment for Interventional Procedures User Quality Control Mode
NEMA XR 27-2012 X-ray Equipment for Interventional Procedures User Quality Control Mode Published by: National Electrical Manufacturers Association 1300 North 17th Street, Suite 1752 Rosslyn, Virginia
More informationCo-ordination of the Group of Notified Bodies for the Construction Products Directive 89/106/EEC. GNB-CPD Conference on CPR
GNB-CPD All Co-ordination of the Group of Notified Bodies for the Construction Products Directive 89/106/EEC NB-CPD/All-13/112 Issued: 13 June 2013 Answers to GNB- CPD questions GNB-CPD Conference on CPR
More informationOverview on Medicines Regulation: regulatory cooperation and harmonization in focus
Overview on Medicines Regulation: regulatory cooperation and harmonization in focus Dr Samvel Azatyan Manager, Medicines Regulatory Support Programme Quality Assurance and Safety: Medicines Essential Medicines
More informationOffice for Nuclear Regulation Strategy
Office for Nuclear Regulation Strategy 2015 to 2020 Office for Nuclear Regulation page 1 of 12 Office for Nuclear Regulation page 2 of 12 Office for Nuclear Regulation Strategy 2015 to 2020 Presented to
More informationLICENSING THE PALLAS-REACTOR USING THE CONCEPTUAL SAFETY DOCUMENT
LICENSING THE PALLAS-REACTOR USING THE CONCEPTUAL SAFETY DOCUMENT M. VISSER, N.D. VAN DER LINDEN Licensing and compliance department, PALLAS Comeniusstraat 8, 1018 MS Alkmaar, The Netherlands 1. Abstract
More informationSAINT VINCENT AND THE GRENADINES TELECOMMUNICATIONS (SPECTRUM MANAGEMENT) REGULATIONS 2007 ARRANGEMENT OF REGULATIONS PART I PRELIMINARY PART II
SAINT VINCENT AND THE GRENADINES Regulation TELECOMMUNICATIONS (SPECTRUM MANAGEMENT) REGULATIONS 2007 ARRANGEMENT OF REGULATIONS 1. Citation 2. Interpretation and Application PART I PRELIMINARY PART II
More informationRADIO SPECTRUM POLICY GROUP. Commission activities related to radio spectrum policy
EUROPEAN COMMISSION Directorate-General for Communications Networks, Content and Technology Electronic Communications Networks and Services Radio Spectrum Policy Group RSPG Secretariat Brussels, 05 June
More informationEnpr EMA. Enpr-EMA. European Network of Paediatric Research at the European Medicines Agency
Enpr EMA European Network of Paediatric Research at the European Medicines Agency Enpr-EMA European Network of Paediatric Research at the European Medicines Agency An agency of the European Union Enpr
More informationETSI EN V1.3.1 ( ) Harmonized European Standard (Telecommunications series)
EN 302 435-2 V1.3.1 (2009-12) Harmonized European Standard (Telecommunications series) Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Technical characteristics
More informationETSI EN V1.3.2 ( ) Harmonized European Standard (Telecommunications series)
EN 302 288-2 V1.3.2 (2009-01) Harmonized European Standard (Telecommunications series) Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices; Road Transport and Traffic Telematics
More informationPDA 71 Years of Connecting People, Science and Regulation
PDA 71 Years of Connecting People, Science and Regulation 1 I m happy to be here. Bom Dia. Estou feliz por estar aqui. Richard M. Johnson PDA President & CEO since 2009 38 years experience in US and International
More informationDesign and Technology
2017 HIGHER SCHOOL CERTIFICATE EXAMINATION Design and Technology General Instructions Reading time 5 minutes Working time 1 1 2 hours Write using black pen Write your Centre Number and Student Number at
More informationSUMMARY. Adopt draft Decision 19.2/1 Roadmap to Enhanced WMO Technical Regulations Framework.
World Meteorological Organization EXECUTIVE COUNCIL Sixty-Eighth Session Geneva, 15 to 24 June 2016 EC-68/Doc. 19.2 Submitted by: President 21.VI.2016 APPROVED AGENDA ITEM 19: AGENDA ITEM 19.2: GENERAL
More informationETSI EN V1.1.1 ( )
EN 300 718-2 V1.1.1 (2001-05) Candidate Harmonized European Standard (Telecommunications series) Electromagnetic compatibility and Radio spectrum Matters (ERM); Avalanche Beacons; Transmitter-receiver
More informationWG food contact materials
WG food contact materials Monday 30 January European Commission DG SANTE, Unit E2 Food Processing Technologies and Novel Foods Food Contact Materials This presentation does not present any official views
More informationConvergence and Differentiation within the Framework of European Scientific and Technical Cooperation on HTA
EUnetHTA European network for Health Technology Assessment Convergence and Differentiation within the Framework of European Scientific and Technical Cooperation on HTA University of Tokyo, October 24,
More informationPrepared by the Working Group on the Use of Nuclear Power Sources in Outer Space
United Nations General Assembly Distr.: General 1 March 2017 Original: English Committee on the Peaceful Uses of Outer Space Scientific and Technical Subcommittee Report on the status of implementation
More informationDraft ETSI EN V2.1.0 ( )
The present document can be downloaded from: Draft ETSI EN 302 208-2 V2.1.0 (2014-06) Electromagnetic compatibility and Radio spectrum Matters (ERM); Radio Frequency Identification Equipment operating
More informationISO INTERNATIONAL STANDARD. Collets with 8 setting angle for tool shanks Collets, nuts and fitting dimensions
INTERNATIONAL STANDARD ISO 15488 Second edition 2003-11-15 Collets with 8 setting angle for tool shanks Collets, nuts and fitting dimensions Pinces de serrage avec angle de réglage de 8 pour queues d'outil
More informationOffice for Nuclear Regulation
Office for Nuclear Regulation ASSESSMENT REPORT Civil Nuclear Reactors Programme NNB Genco: Hinkley Point C Pre-Construction Safety Report 2012 Assessment Report for Work Stream B14, Radiation Protection
More informationAustralian/New Zealand Standard
AS/NZS 61000.4.11:2005 AS/NZS 61000.4.11:2005 Australian/New Zealand Standard Electromagnetic compatibility (EMC) Part 4.11: Testing and measurement techniques Voltage dips, short interruptions and voltage
More informationGetting the evidence: Using research in policy making
Getting the evidence: Using research in policy making REPORT BY THE COMPTROLLER AND AUDITOR GENERAL HC 586-I Session 2002-2003: 16 April 2003 LONDON: The Stationery Office 14.00 Two volumes not to be sold
More informationCEN-CENELEC JWG10 'Energy-related products Material Efficiency Aspects for Ecodesign'
CEN-CENELEC JWG10 'Energy-related products Material Efficiency Aspects for Ecodesign' Proposed Project Teams: It is proposed that the following PTs be installed. The exact PT teams and the work they will
More informationRitch Rappel Enbridge
Ritch Rappel Enbridge Pipeline Safety Trust October 21, 2016 Quality is Free When it is Done Right. n Inspection does more quantity survey than quality documentation." n Each inspector is required to complete
More informationJoint - Jobs, Enterprise and Innovation. Opening Statement. Brian Hogan Marine Survey Office. Date: 21 September 2017
Joint - Jobs, Enterprise and Innovation Opening Statement Brian Hogan Marine Survey Office Date: 21 September 2017 I thank the Chairman and Committee Members for inviting me here today. The issues which
More informationReport OIE Animal Welfare Global Forum Supporting implementation of OIE Standards Paris, France, March 2018
Report OIE Animal Welfare Global Forum Supporting implementation of OIE Standards Paris, France, 28-29 March 2018 1. Background: In fulfilling its mandate to protect animal health and welfare, the OIE
More informationDEVELOPMENTS IN EU MDD & IVDD SOFTWARE REGULATION
Objectives DEVELOPMENTS IN EU MDD & IVDD SOFTWARE REGULATION Some brief remarks on data protection Current regulation of medical devices software Overview of EU medical devices directives revision process
More informationISO/TR 2801 Clothing for protection against heat and flame General recommendations for selection, care and use of protective clothing
TECHNICAL REPORT ISO/TR 2801 First edition 2007-02-01 Clothing for protection against heat and flame General recommendations for selection, care and use of protective clothing Vêtements de protection contre
More informationASD EUROSPACE RESEARCH AND TECHNOLOGY COMMITTEE (SRTC)
ASD EUROSPACE RESEARCH AND TECHNOLOGY COMMITTEE (SRTC) TERMS OF REFERENCE RT PANEL APPROVED 18/02/2011 GENERAL This document describes the terms of reference for the Space Research and Technology Committee
More informationISO INTERNATIONAL STANDARD. Nomenclature Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange
INTERNATIONAL STANDARD ISO 15225 First edition 2000-09-15 Nomenclature Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange Nomenclature Spécifications
More informationETSI EN V1.4.1 ( )
EN 300 296-2 V1.4.1 (2013-08) Harmonized European Standard Electromagnetic compatibility and Radio spectrum Matters (ERM); Land Mobile Service; Radio equipment using integral antennas intended primarily
More informationDraft Guidance Statement on Mine Dewatering
Submission February 2016 Draft Guidance Statement on Mine Dewatering Department of Environment Regulation Contact Kirrillie Caldwell k.caldwell@cmewa.com The Chamber of Minerals and Energy of Western Australia
More informationICAEW is pleased to respond to your request for comments on the consultation paper Considerations of Materiality in Financial Reporting.
20 February 2012 Our ref: ICAEW Rep 17/12 Your ref: ESMA/2011/373 European Securities and Markets Authority 103 rue de Grenelle 75007 Paris France Dear Sirs CONSIDERATIONS OF MATERIALITY IN FINANCIAL REPORTING
More informationCADTH HEALTH TECHNOLOGY MANAGEMENT PROGRAM Horizon Scanning Products and Services Processes
CADTH HEALTH TECHNOLOGY MANAGEMENT PROGRAM Horizon Scanning Products and Services Processes Service Line: Health Technology Management Program Version: 1.0 Publication Date: September 2017 Report Length:
More informationPharmacovigilance System - EU
Pharmacovigilance System - EU Rechtsanwalt Prof. Burkhard Sträter Sträter Rechtsanwälte Kronprinzenstraße 20 Fon: +49 (0) 228-934 54-0 mail@straeterlawyers.de D-53173 Bonn Fax: +49 (0) 228-934 54-54 Pharmacovigilance
More information