Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbHwww.ages.at ASMF-AR – database ad-hoc group on ASMF assessment Christa Wirthumer-Hoche.

Slides:

Advertisements

Similar presentations

OMV Ontology Metadata Vocabulary April 10, 2008 Peter Haase.

Advertisements

EU Open Data Portals and Infrastructures Open EU Publications Office Luca Martinelli Publications Office of the European Union Seminar Open Government.

1 Future strategy for e-submission as seen by industry Dr Michael Colmorgen, IFAH-Europe 2nd Veterinary Workshop on E-submission 4 Dec 2009, EMEA, London.

1 Harmonisation of requirements: where we are Erik Waterdrinker, IFAH-Europe 2nd Veterinary Workshop on E-submission 4 Dec 2009, EMEA, London.

Council of Europe Eastern Partnership Facility 2 nd Steering Committee meeting 6 June 2012 Brussels CoE Facility.

The e-Justice Portal and the interconnection of land registers – state of play Dick Heimans Deputy Head of Unit B2 – DG JUST.

CMD(h) Report Progress report Truus Janse-de Hoog HMA meeting Budapest April 2011.

Place your chosen image here. The four corners must just cover the arrow tips. For covers, the three pictures should be the same size and in a straight.

INSPIRE vs. PSI re-use Directives comparison Roger Longhorn Director, Info-Dynamics Research Associates Ltd /

Sultan Ghani WHO Prequalification Programme of Priority Essential Medicines, October 2010, Abu Dhabi, U.A.E. Active Pharmaceutical Ingredient Master.

QUALITY OF SERVICE TRAINING PROGRAMME Jaroslaw Ponder Coordinator, Europe Region 1.

EFPIA EFPIA IT Proposals ppt Slide 1 EFPIA Proposals for IT Support to the European Regulatory Procedures Mr S. Hasler EFPIA PAT Regulation 2000.

EMACOLEX, May 2011 Recent activities of the HMA/EMA Transparency Group Tina Engraff Legal Adviser, Danish Medicines Agency.

IAEA International Atomic Energy Agency How do you know how far you have got? How much you still have to do? Are we nearly there yet? What – Who – When.

Need for integrated and sustainable regulatory surveillance of veterinary biologicals Gábor Kulcsár VBRN Advisory Group Meeting of HMA, Visegrád, 28 April.

Agricultural Market Information System (AMIS): State of Play AMIS First Meeting of the Rapid Response Forum 11 April 2012 Mexico City Abdolreza Abbassian,

Quality of Substances for Pharmaceutical Use: The EDQM Certification of Suitability to the European Pharmacopoeia Monographs (CEP) Dr. Susanne Keitel DIA.

An agency of the European Union Presented by: David Mackay Head of Unit, Veterinary Medicines & Product Data Management Unit Incident Management Plan Veterinary.

Report - HMA/EMEA Office of Training Steering Group Dr. Gro Ramsten Wesenberg Co-chair.

Creating a Single European Energy Market – the Regulatory Perspective London, 30. January 2007 ERGEG Electricity Regional Initiative Central-East Europe.

ICG-WIGOS-3 Status of the WIGOS Operational Information Resource (WIR) Etienne Charpentier (OBS/WIGOS/OSD) WMO; OBS.

DMF Procedures and Communication between API, FP Manufacturers and Regulatory Authorities Jean-Louis ROBERT National Health Laboratory L – 1011 LUXEMBOURG.

Consultant: CMDC Joint Venture Reflections on draft Recommendations for Revision to Administrative Regulations: By Norman Sheridan, Legal & Institutional.

DEPARTMENT OF HEALTH Medicines Regulatory Affairs

Paediatric Worksharing CMDh participation Work-sharing in Art 45 and 46 procedures Experiences in Art 29 procedures Presidency meeting 29 September 2011.

SEVESO II transposition and implementation – possible approaches and lessons learned from MS/NMS SEVESO II transposition and implementation – possible.

Special Educational Needs Reforms What is happening in Wandsworth.

Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Regulatory Authority.

JRA Execution Plan 13 January JRA1 Execution Plan Frédéric Hemmer EGEE Middleware Manager EGEE is proposed as a project funded by the European.

Group 1 – Monitoring, reporting and evaluation of adaptation at national level Chair: Stéphane Isoard (EEA) Rapporteur: Sergio Castellari (EEA)

Can REACH become the New Global Model? Helsinki Chemicals Forum 20 May 2010 Jukka Malm, Director ECHA – Directorate of Assessment.

1 - DG ENV Brussels, 5 March 2003 Draft INSPIRE Legislative proposal The key issues 9th INSPIRE Expert Group Meeting Brussels.

NCP training session 30 October 2002 Integrated information system on RTD in Europe Gwenda Jeffreys-Jones, DG RTD European Commission.

Gabriela Macoveiu North-East RDA, Romania PP11 – WP responsible Cluster Policy Learning Platform WP3 Description Smarter Cluster Policies for South-East.

National Nuclear Regulatory Portal (NNRP) (Concept, Development and Experience) FNRBA Training Course on Knowledge Safety Networks, 14–18 October 2013,

International conference Quality of Active Pharmaceutical Ingredients Hyderabad, September 2009 API Inspections: the EDQM experience – 7 September.

The FDES revision process: progress so far, state of the art, the way forward United Nations Statistics Division.

Joint Procurement of medical countermeasures EMCDDA Workshop Lisbon, 16 june 2015.

National Agencies’ contribution to the evaluation of Grundtvig Action and to the National Evaluation Report on Socrates Programme Socrates - Grundtvig.

SEVESO II transposition and implementation: Possible approaches and lessons learned from member states and new member states SEVESO II transposition and.

3rd Helix Nebula Workshop on Interoperability among e-Infrastructures and Commercial Clouds Carmela ASERO, EGI.eu 17 September 2013, Madrid

European Commission / Taxation and Customs Union June 2009 UNECE REGIONAL CONFERENCE ON TRADE FACILITATION 1 Single Window European Commission.

ROAD INFRASTRUCTURE SAFETY MANAGEMENT DIRECTIVE (RISM) Harry Cullen SPM Road Safety, National Roads Authority, Ireland Chairman of CEDR Technical Group.

Overview of the EU regulatory system and governance

DMF Procedures and Communication between API, FFP Manufacturers and Regulatory Authorities Jean-Louis ROBERT National Health Laboratory L – 1011 LUXEMBOURG.

A network of European National Platforms and Focal Points for Natural Disaster Reduction Common Goals To facilitate and improve the exchange of information.

Energy Meeting with the NGOs Taipei, 25 September 2013 Christian Kirchsteiger European Commission, Directorate-General for Energy (DG ENER) EU Policy Context.

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.

Proprietary and confidential. Do not distribute.Deck Title1 May, 2016 DG CONNECT European Catalogue KEY RULES & DECISION MAKING Trilateral: Monica Lagazio,

PHC Meeting the global challenge of unique identification of medicinal products SMS, RMS and OMS : Common Terminologies for enabling ISO IDMP.

An agency of the European Union EU ISO IDMP Roadmap to enable eprescription cross-borders Towards a trans-atlantic solution to univocally identify medicinal.

ISO 14001:2004 Clause 4.3 Planning. Clause 4.3 Planning Key Requirements of Environmental Management System Certification.

Periodic Safety Update Reports (PSUR)

IDMP Update for Bayer 22nd March 2017.

Christian Ansorge Arona, 09/04/2014

Updated eSubmission Roadmap (v.2.1) Adopted by HMA on

Biosafety Clearing-House Training Workshop

Update on European Network Codes

Reffering to the presentation on 28 June, TWG in November?

Business Cases and Advantages of eCTD v4.0

Governance, Information & Reporting (DG ENV D4)

The Commission Communication on implementation (COM (2012) 95) in relation to Water Industry Directives (Urban Waste Water Treatment, Drinking Water,

Ag.no.15.1 and 15.3 Dissemination of A65 data

THE INTRODUCTION OF NUCLEAR POWER IN EGYPT AN OVERVIEW

The evaluation process

By Daniel RASE, Eurostat

DocsRoom Public Documents Register Pilot: by DG ENTR

Overview of the recommendations on software updates

EUnetHTA Assembly May 2018.

Updated eSubmission Roadmap (v2.2) Adopted by HMA on 21 June 2019

Presentation transcript:

Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbHwww.ages.at ASMF-AR – database ad-hoc group on ASMF assessment Christa Wirthumer-Hoche Vienna, AT 28 April 2011 HMA-h

2 Current ASMF assessment The same ASMF o same AS o same manufacturing site o same route of synthesis often used in different dossiers for multiple procedures assessed by different assessors. o MRP/DCP o CP o Human/veterinary -Currently there is no Worksharing -Currently there is no common platform for information on ASMFs in Europe -No ASMF-AR database

3 Ad-hoc group on ASMF assessment Scope: -Procedural aspects of ASMF assessment Goal: -To investigate the feasibility - practical and legal aspects of, and consider proposals for: o one central assessment for ASMF going through CP and DCP o a centralised database for all AR of ASMFs o an EU numbering system for ASMFs -To start with a pilot project Composition of the group: o CMD-h (&v) o Experts from NCAs o CHMP/CVMP (Chair of the QWP) o EMA o EDQM

4 Ad-hoc group on ASMF assessment Several issue have been discussed & clarified already, & Discussions about a common repository for ASMF-ARs A common ASMF-AR repository may contribute to the reduction of overall workload by »Referring to or »Re-using assessments that already have been made in the EU regulatory network.

5 Requirements for a common platform The platform should be designed in such a way that it allows all concerned parties to participate without problems. The platform should be designed in such a way that it allows data-exchange with other systems. As far as possible agreed EU-IT interoperability measures as e.g. RDM and EUTCT have to be used. The platform has to be implemented in a secure way, ensuring that only authorized persons/agencies have access to the system.

6 AR-submission In addition to the AR-file(s) the relevant meta-data for the ASMF should be entered The system should allow for a connection to CTS for procedural data Searching: The system should allow a Google-like search -documents content or -within the attached meta-data.

7 Hosting the ASMF-AR platform -2 „friendly volunteers“ are prepared to host the database for ASMF-ARs:  BfArM/DIMDI (within CTS)  EDQM (within the existing EDQM DB) HMA to decide which option to be chosen

8 CTSEDQM Fully meets the requirements as stated in the specification document xx Link to regulatory MR/DC proceduresx- Used in daily workx- Support by CTS helpdeskx- Information about EDQM inspections for manufacturers of APIs -x One Data base for ASMF and CEP-x Pros & Cons of CTS vs EDQM

9 costs for development timelinesowner CTS €, 2011 balanced against a surplus from preceding CTS budget Dec for testing HMA EDQM €Nov for testing EDQM (Council of Europe)

10 HMA decision HMA to decide which option to be chosen for further development  BfArM/DIMDI (within CTS)?  EDQM (within the existing EDQM DB)?