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Alerting Reporting and Surveillance System for Chemical Health Threats Phase III (ASHTIII) ASHTIII WP1- Co-ordination Plan (D1) Appendices Final version v2.1 27th November 2012 Lead Partner Organisation Crabbe H, Orford R, Duarte-Davidson R HPA Associate Partners Settimi L NHI- ISS Andrew E PIN Mathieu-Nolf M CHRU-Lille Dragelyte G, Badaras R HESC Pelclova D, Zakarahov S GFH Schaper A, Desel H UMG-GOE Subcontractors Devanza F, Sesanza F MPC Funding and disclaimer This report arises from the project Alerting, Reporting and Surveillance System for Chemical Health Threats Phase III (ASHTII; project number 20111101) which has received funding from the European Union, in the framework of the Health Programme. Sole responsibility for this publication lies with the authors and the Executive Agency for Health and Consumers is not responsible for any use that may be made of the information contained therein.

Alerting Reporting and Surveillance System for Chemical ... · 4 Sergey Zakharov Raquel Duarte-Davidson Access details for the audio conference: Dial in details – as above. Participation

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Alerting Reporting and Surveillance System for

Chemical Health Threats Phase III (ASHTIII)

ASHTIII WP1- Co-ordination Plan (D1)

Appendices Final version v2.1 27th November 2012

Lead Partner Organisation

Crabbe H, Orford R, Duarte-Davidson R HPA

Associate Partners

Settimi L NHI- ISS

Andrew E PIN

Mathieu-Nolf M CHRU-Lille

Dragelyte G, Badaras R HESC

Pelclova D, Zakarahov S GFH

Schaper A, Desel H UMG-GOE

Subcontractors

Devanza F, Sesanza F MPC

Funding and disclaimer

This report arises from the project Alerting, Reporting and Surveillance System for Chemical Health Threats Phase III (ASHTII; project number 20111101) which has received funding from the European Union, in the framework of the Health Programme.

Sole responsibility for this publication lies with the authors and the Executive Agency for Health and Consumers is not responsible for any use that may be made of the information contained therein.

2

Contents:

Appendix A- ...................................................................................................................................... 3

Appendix B- ...................................................................................................................................... 6

Appendix C- ................................................................................................................................... 34

Appendix D- ................................................................................................................................... 35

3

Appendix A- Example Agenda of a project Teleconference.

ASHTIII Teleconference

Wednesday 1

st August 2012

Teleconference

10.30am (BST); 11.30am (CEST); 12.30pm (EET) (for 1 hour)

DRAFT AGENDA

Invited attendees:

Free-phone number Local number Participation

code

Erik Andrews 800 40 932 47 2316 2602

496301#

Laura Settimi 800 124 799 39 064 5210 8276

Franca Davanzo 800 124 799 39 064 5210 8276

Fabrizio Sesana 800 124 799 39 064 5210 8276

Herbert Desel 0800 101 2089 49 69 5899 90859

Andreas Schaper 0800 101 2089 49 69 5899 90859

Daniela Pelclová 800 900 593 420 2 3900 0391

Sergey Zakharov 800 900 593 420 2 3900 0391

Gabija Dragelyté 8800 30 214 N/A

Robertas Badaras 8800 30 214 N/A

Monique Mathieu-Nolf 0800 941 447 33 1 70 993 561

Jurgita Kaminskiate 800 23862 352 3420 808 108

Vasilis Zaharopoulo 800 23862 352 3420 808 108

Lucija Šarc 0800 004 946 N/A

Simon Dyer 0800 358 0872 0208 609 7401

Anne-Catherine Viso 0800 941 447 33 1 70 993 561

Sandra Sinno-Tellier 0800 941 447 33 1 70 993 561

Joanna Tempowski 0800 000 858 41 43 456 9070

Hugo Kupferschmidt 0800 000 858 41 43 456 9070

Eva Rump 0800 101 2089 49 69 5899 90859

Al Bronstein 1 866 262 7343 1 718 354 1241

Raquel Duarte-Davidson 0800 358 0872 0208 609 7401

Helen Crabbe 0800 358 0872 0208 609 7401

Rob Orford 0800 358 0872 0208 609 7401

Anne Dempsey 0800 358 0872 0208 609 7401

In case of technical difficulties with free-phone number please try the local

number

Apologies:

Erik Andrews

4

Sergey Zakharov

Raquel Duarte-Davidson

Access details for the audio conference :

Dial in details – as above.

Participation code - 496301

Access details for the web conference :

RO will host the web conference please forward any documents that you would like presented at

least one hour before the start.

For those who would also like to join by web-conference please follow the instructions below.

1. Join the teleconference as usual using the above dial and participant code. 2. From your PC enter the URL http://connect.actconferencing.com 3. Select join meeting as a participant. 4. Enter the Guest code : 496301 5. Enter your name and join the meeting.

Items:

1. Apologies

2. Welcome Collaborating Partners to TCs

3. Minutes of last TC and review of actions

4. WP1- Coordination:

a. Revised Timetable

b. NDAs and DESCA agreements

c. WP co-ordination plans

d. WP working groups

e. WP1, 2 and 3 strategy plan due 31st August.

5. WP2- Dissemination:

a. Discussion about ASHT.EU website for hosting project information and IT-

Tools

b. Project documentation- leaflet, EC logo

6. WP3: Evaluation - Discussion about evaluation strategy

7. WP4: CEM Sheets: Discussion about focus and purpose

8. WP5: Pesticides/Biocides

a. Development of data sharing agreement

9. WP6: Network of Experts: Discussion about drafting the ‘Network’ terms of reference

10. WP7:

a. WP7a: Discussion about data mining framework agreement

b. WP7b: Discussion about DEV-RAS-CHEM and closed lists

5

11. Finances (AD)

12. AOB and questions

13. Date and time of next TC.

6

Appendix B- Work Package Co-ordination Plans

7

ASHTIII Work Packages Co-ordination Plans

Work package name

and number

WP1: Co-ordination

WP lead Raquel Duarte-Davidson, HPA

WP description

(from Annexe 1a

and 1b)

The HPA will lead on the project co-ordination, including technical management of the project, to ensure milestones and deliverables are met on time and manage the contractual and financial administration of the contract on behalf of the European Commission. The coordination and overall supervision of the project will include: 1. Using best practice project management techniques (following PRINCE2 principles and lessons learned from previous experience) to ensure the project achieves its specified objectives and that all deliverables are met on time, risks are minimized and a good working relationship with project partners is maintained. 2. Maintaining regular contact with project partners (via phone and e-mail) and holding regular project update teleconferences between partners to ensure good communication and understanding of the project requirements and to foster good working relationships between partners. 3. Organising regular coordination meetings, including a kick-off meeting (M1), interim project meeting (M16) and final meeting (M28) to report on project progress and discuss technical and management aspects of the project. 4. To take responsibility for the preparation of documents for meetings and incorporating documents submitted by work package leads into an overall project work-package reports. Collaborative-working software (i.e. CIRCA-IT) will be used to share project documents with controlled access. 5. Collating information from partners to prepare relevant progress reports to be submitted to the Commission (interim report in month 15+2) and final overall project report (month 30+2). Ensuring proper financial management of the project including timely submission of invoices and payment to partners. 6. Conflict resolution - any conflicts met during the execution of the project will be met as follows: Minor conflicts (e.g. minor technical and procedural issues) will be resolved by discussion with the final decision lying with the project coordinator, if agreement cannot be reached. For conflicts of a more substantial nature, resolution will be sought through discussion to reach a common agreement and way forward between parties, if agreement still cannot be reached, the help of an independent mediator will be sought to find a way forward and common agreement. Where appropriate, expert input and advice from relevant stakeholders (e.g. EC, EAHC, technical experts) will be sought to assist with the conflict resolution. The HPA has a strict policy on internal sign off of documents to ensure that relevant authority from both within the project group and via senior managers is sought prior to publication of any reports externally. HPA will also seek approval to publish via DG-SANCO and the EAHC where appropriate.

Associate Partners

(institutions and

named individuals)

UMG-GOE(HD,AS), HESC(GD, RB), GUH(DP, SZ), NHI(ISS) (LS), CHRU-Lille (MMN), PIN (EA) And subcontractors- Milano Poisons Information Centre (FD, FS)

Collaborating

partners

EAPCCT(IdV), AAPCC(AB), WHO(Geneva) (JT), STIC (HK), DH-UK (SD), MeDRA (ER), CEFIC (CM), NPIC Ireland (ED), NPIS-UK, InVS (ACV, SST, SM)

8

(institutions and

named individuals

Deliverables:

(from Annexe 1a)

Deadlines:

(including draft

report deadlines)

Co-ordination and Dissemination Plan (M3- September 2012)

Interim project report (M17- October 2013)

Final project report- (M30- November 2014)

Milestones:

(from Annexe 1a)

Deadlines:

(including draft

report deadlines if

applicable)

Kick off meeting- (M1- June 2012- complete) Interim Project Meeting (M16- September 2013- Vilnius, Lithuania) Interim project report (M17- October 2013)- Draft deadline M16- September 2013)

Final project meeting- (M28- September 2014- Luxembourg)

Final project report- (M30- November 2014)- draft deadline M29- October 2014)

WP specific

objective relevant

to WP (see Annexe

1a, WP3, evaluation

strategy, p38-40.

Note objective

numbers do not

relate to WP

number).

List title and

number:

Non particular to WP1 To co-ordinate work for meeting all project objectives

Objective indicators

(see Annexe 1a,

WP3, evaluation

strategy, p38-40)

List process

indicators, output

indicators and

outcome indicators

relevant to this WP.

As above

Plans of action for

achieving objectives

and indicators

(i.e. what are you

going to do to

achieve the process,

output and

outcomes

Monthly project co-ordination Teleconferences (TC) Circulate Agendas for TCs. Minutes to record actions and agreements of TCs. Project Manager (HC) to co-ordinate the management of the project. Project Technical Manager (RO) to co-ordinate and steer the technical work for the project. Reminders to WP leads to steer the WP work and meet deadlines and timescales for the WP objectives. Appoint evaluators to evaluate the projects achievements (related to WP3).

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indicators?)

Stakeholders for

WP, objectives,

indicators.

Partners, Collaborating Partners, European Commission officers, Poison Centres in MS, Public Health Authorities in MS.

Target audience, for

outcomes of WP

(see Annexe 1a,

WP2, p36)

Public, EAHC, DG SANCO, MS Health Authorities, EU Poisons Centres and Public Health professionals.

Distribution channel

and method (e.g.

see Annexe 1a, WP2,

p36)

EAHC, Project website, CIRCABC, Publications in relevant journals, Publication of report on findings from consultation on project web sites and EU journals.

Associate Partners and Collaboration Partners websites.

Working

arrangements for

the WP (e.g. WP

specific TCs, working

group, email group,

meetings planned,

frequency of

meetings, etc.)

WP1 monthly TCs with agendas and minutes.

Email distribution lists.

Organise WP working groups and subgroups.

3 project management meetings: Kick Off, interim and final meetings.

Other relevant

information for the

WP

A project Consortium Agreement is being drafted to formalise the working arrangements of the Associate Partners to deliver the project. Non-disclosure Agreements are proposed for Collaborating Partners to control the information flows and sharing of project information.

Sheet Version: v0.1

Date: 03/07/12

10

ASHTIII Work Packages Co-ordination Plans

Work package name and number

Work-package 2: Dissemination

WP lead Lead HESC, Lithuania- Gabija Dragelytė Supported by Robertas Badaras and Helen Crabbe

WP description (from Annexe 1a and 1b)

A project dissemination working group will act to promote awareness in MS authorities, professional interest groups, social groups and political spheres both inside and outside of the EU. The dissemination of ASHTIII will include a commitment to submit ASHTIII results to two peer reviewed papers (i.e. EU PC data mining and toxidrome matrix evaluation), with general update articles in HPA publications for the professional and lay reader. Project information on the internet will be updated regularly to raise awareness and interest in the project and chemical health threats. Project updates will also be presented at appropriate meetings and conferences. Dissemination of the project will benefit from a close working relationship with the EAPCCT. As with ASHTII, annual project newsletters, leaflets, flyers will be produced in at least eight EU languages for distribution at international meetings, project partners and will be also available to download at the ASHTIII and project partner web-sites.

Dissemination will be an on-going activity throughout the project to generate and disseminate health information and knowledge by exchanging knowledge and best practice and to reinforce global health security capacity with regard to chemical threats. Authorities from local to international, that have an interest or responsibility for the management of chemical incidents, will be targeted with the dissemination strategy to promote wider engagement and uptake of the RAS-CHEM.

Associate Partners (institutions and named individuals)

Health Protection Agency, Centre for Radiation, Chemicals and Environmental Hazards (CRCE), Oxfordshire, UK.

Universitaetsmedizin Goettingen, Georg-August-Universitaet, GIZ-Nord Poisons Centre, Goettingen, Germany.

Centre Hospitalier Universitaire de Lille, Poisons Information Centre, Lille, France.

Health Emergency Situations Centre, Poisons Control and Information Bureau, Vilnius, Lithuania.

Norwegian Poisons Information Centre, Norwegian Directorate of Health, Oslo, Norway.

National Institute of Health (Istituto Superiore di Sanità), NHI (ISS), Rome, Italy.

General University Hospital, Toxicological Information Centre (TIS), Department of Occupational Medicine, Prague, Czech Republic.

Collaborating partners (institutions and

Institut de Veille Sanitaire (INVS), France

Bundesterinstitut fur Risikobewertung (BfR), Germany

Medical Dictionary for Medical Regulatory Authorities (MedDRA)

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named individuals European Association of Poisons Centres and Clinical Toxicologists (EAPPCT)

World Health Organisation (WHO)

European Chemical Industry Council, EU (CEFIC)

Department of Health, United Kingdom

Ministry of Health, Czech Republic

Ministry of Health, Germany

American Association of Poisons Control Centres, USA (AAPCC)

Swiss Toxicological Information Centre, Switzerland

National Poisons Information Centre, Ireland

Deliverables: (from Annexe 1a) Deadlines: (including draft report deadlines)

1. Coordination and dissemination plan- M3 September 2012.

2. Project Dissemination report- M30 December 2014.

Drafts due 1 month before deadlines i.e.

1. 30th August 2012

2. 30th November 2014.

Milestones: (from Annexe 1a)

Deadlines: (including draft report deadlines if applicable)

1. Dissemination strategy plan – month 3 2. Project evaluation report (WP3)– month 30- December 2014 3. EAPCCT congress satellite meeting – month 12- May 2013,

Copenhagen 4. EAPCCT congress satellite meeting – month 24- May 2014, Brussels

WP specific objective relevant to WP (see Annexe 1a, WP3, evaluation strategy, p38-40. Note objective numbers do not relate to WP number). List title and number:

Two objectives for this WP: 1. To disseminate information on the project using a variety of

information channels to increase awareness of the projects objectives, updates and outputs.

2. To engage stakeholders in the projects activities, to gain awareness and participation of PCs and public health authorities (PHA) in the project.

Objective indicators (see Annexe 1a, WP3, evaluation strategy, p38-40) List process indicators, output indicators and outcome indicators relevant to this WP.

Indicators listed in the Contract are not wholly relevant to this WP. Therefore the following indicators can be used.

1. The number of information channels that the project is advertised through.

2. The number of organisations that have engaged with the project, signed up to be collaborating partners and/or have heard of the projects aims.

3. The number of hits of the projects website, and analysis of where these hits come from using google analytics.

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Plans of action for achieving objectives and indicators (i.e. what are you going to do to achieve the process, output and outcomes indicators?)

1. Write a dissemination plan proposing activities for consultation and agreement with EAHC by September 2012 (M3). 2. Set up and maintain project website: www.ASHT.eu 3. Design and distribute project leaflet 4. Write and disseminate/publish project articles and updates in newsletters and other forums. Include at least 2 peer reviewed articles in journals. 5. Investigate the use of social media for disseminating project updates, e.g. Facebook, LinkedIn, twitter. 6. Disseminate project information through partner and CP websites. 7. Engage stakeholders in project outputs through establishing contacts with PCs and Public Health authorities in Europe and outside Europe, e.g. Eastern non-EU European countries, Russia, Baltic and Nordic countries. 8. Meet with representatives from Nordic PCs to gain involvement in the project. 9. Meeting of Health authorities and PC of Baltic states

10.Collaborating with Lithuanian Military medical service

Stakeholders for WP, objectives, indicators.

PCs and Public Health authorities in Europe, also outside Europe, e.g. Eastern non- EU European countries, Russia, Baltic and Nordic countries. EAHC, users of RAS-CHEM, clinical toxicologists, medics, risk managers and risk assessors for chemical incidents, emergency responders, and competent authorities.

Target audience, for outcomes of WP (see Annexe 1a, WP2, p36)

MS Health Authorities, EU Poison centres, DG-SANCO, EAHC and public

Distribution channel and method (e.g. see Annexe 1a, WP2, p36)

EAHC (2 copies of reports), CIRCABC-IT, project website, leaflets, newsletters, articles in relevant professional literature, local and international meetings.

Working arrangements for the WP (e.g. WP specific TCs, working group, email group, meetings planned, frequency of meetings, etc.)

1. WP specific working group, email group and Teleconferences with monthly catch ups

2. WP2 specific working group comprising of steering members: GD, RB, HC, RO, RDD.

3. Wider working group comprising partners and collaborating partners to support dissemination to additional MS.

Other relevant information for the WP

Sheet Version: v0.1 Date: 03/07/12

13

ASHTIII Work Packages Co-ordination Plans

Work package name

and number

WP3: Evaluation of Project

WP lead HPA

WP description

(from Annexe 1a

and 1b)

Evaluation will be on-going throughout the ASHTIII project. External: The evaluation report aims to measure ‘buy-in’ and ‘uptake’ of RAS-CHEM by end–users and decision making authorities, provide objective measurable evidence of the interest in the project outputs by including summative metadata on system usage (RAS-CHEM; DEV-RASCHEM) including the use of Google Analytics to measure site visit numbers and MS traffic (project web portals). The report will also evaluate the benefits and usefulness of specific project objectives via the dissemination strategy and the interest groups. The report will include feedback on the IT tools, harmonised patient management sheets, biocide/pesticide reporting, future buy-in and sustainability. Technical and political obstacles to full implementation in the EU-27 will also be documented in the Evaluation report. Internal: The evaluation report will document the efforts of the group and audit the outputs of the monthly update teleconferences, workshops and meetings. The report will demonstrate how and when the projects deliverables were met. Evaluation measures and indicators will be developed and assessed at the 12, 24 and 30 month stage by an external organisation; this will facilitated through a subcontract agreement and will provide an independent review of the effectiveness of the project execution and outcomes.. External experts from relevant organisations (i.e. WHO, EAPCCT) will be engaged to participate project workshops and meetings as well as the evaluation of technical reports and project outputs. Expert peer review evaluators will also be sought from within the project group organisations, or by project group members, to assess and comment on project deliverables, such as work package reports.

Specific Objective 1: Toxidrome Matrix Development

Process indicators Output Indicators Outcomes indicators

WP6/WP7 Workshop in year 1 attended by project group.

Agreement on set of parameters and scope of toxidrome informatics tool

Increased number of high risk chemicals detectable using toxidrome analysis.

Toxidrome matrix IT tool (WP7b) final report submitted in M30

External expert peer review of report

Faster and more efficient identification of high risk chemicals from chemical injuries

Specific Objective 2: Standardised Chemical Casualty Medical

Management Sheets

Process indicators Output Indicators Outcomes indicators

WP4/WP5 workshop in year 1 attended by

Agreement of data fields and structure of

Increased number of standardised data

14

project group. CEMM sheets. sheets for public health management of high risk chemicals

CEMM Sheet work-package report submission in M26

External expert peer review of report

Faster and more efficient access to harmonised guidance on managing chemical incidents for MS authorities.

Specific Objective 3: Harmonised Product Information Relating to

Pesticides and Biocides

Process indicators Output Indicators Outcomes indicators

EAPCCT congress satellite work package 4 discussions in year 2/3 at least 10 completed questionnaires

Discussion and agreement on the use of automated data mining for biocide and pesticide reporting

Increased number of EU Poisons Centres aware of data mining for biocide/pesticide reporting.

External stakeholder consultation on use of RAS-CHEM for biocide & pesticide reporting by M17. Responses from at least 10 different Member State competent authorities.

Improved understanding of the issues and challenges involved in automated data mining of biocide and pesticide data

Increased number of EU MS competent authorities aware of data mining for biocide/pesticide reporting and RAs-CHEM.

Pilot study (linked to WP5/7 and objective 5) on use of data mining to capture biocide and pesticide exposure data

Automated mining of biocide/pesticide exposure data from at least 4 EU PCs over at least 3 months to demonstrate proof of principle.

Faster and more efficient mechanism capture standardised pesticide and biocide of exposures data

WP4 Report submission External expert peer review of report

Faster and more efficient mechanism capture for reporting of biocide and pesticide exposures by EU PCs and MS competent authorities

Specific Objective 4: Clinical Toxicology EU Assessment Network

Process indicators Output Indicators Outcomes indicators

EAPCCT congress satellite work package 6 discussions in year 2/3. number of attendees at satellite meeting and at least 10 completed

Discussion of mechanism for providing expert toxicological input and advice into RAS-CHEM

Increased number of EU PCs aware of the requirement for expert toxicological input and review of RAS-CHEM/CEMM sheet

15

questionnaires (per meeting).

and CEMM sheets data.

WP6 Discussion session at interim meeting. Meeting participation and at least 10 completed questionnaires.

Formulation and agreement of the proposed mechanism to administrate the toxicological content of RAS-CHEM/CEMM sheets to aid chemical incident response of EU MS

Faster and more efficient mechanism to access expert toxicological advice to review for RAS-CHEM content and CEMM sheet development

WP6 Final Report submission at M26

External expert peer review of report

Faster and more efficient access to expert toxicologists to assess chemical health threats and provide consistent advice to the Commission and EU MSs

Specific Objective 5: EU Poisons Centres Data Mining

Process indicators Output Indicators Outcomes indicators

Pilot study (linked to WP5/7 and objective 3) on use of data mining to PC exposure data

Automated mining of PC exposure data from at least 6 EU PCs over at least 6 months to improve upon ASHTII WP4b outputs

Faster and more efficient methods for PC automated data capture

External stakeholder consultation on automated data mining by M17; Responses from at least 20 different Member state competent authorities.

Improved understanding of the issues and challenges involved in automated data mining of exposures data

Increased number of EU PCs aware of automated data mining of exposures data

EAPCCT congress satellite work package 7 discussions in year 2/3. Workshop participation and at least 10 completed questionnaires.

Improved understanding of issues relating to implementation of automated data mining.

Increased number of EU PCs aware of automated data mining of exposures data

Data Mining (WP7a) report submitted in M30

External expert peer review of report

Faster and more efficient methods for the harmonised mining and analysis of information relating to toxic chemical

16

exposures in the EU.

Associate Partners

(institutions and

named individuals)

UMG-GOE, HESC, GUH, NHI (ISS), CHRU de Lille, PIN

Collaborating

partners

(institutions and

named individuals

EAPCCT, AAPCC, WHO(Geneva), Swiss Toxicological Information, Department

of Health (UK), Ministry of Health (Czech Republic), Ministry of Health

(Germany), Ministry of Health (France), National Poisons Information Centre

of Ireland, MeDRA, MTIS, CEFIC, EUPHA

Deliverables:

(from Annexe 1a)

Deadlines:

(including draft

report deadlines)

2. Project Evaluation Plan – M3

10. Project Evaluation Report - M30+2

Milestones:

(from Annexe 1a)

Deadlines:

(including draft

report deadlines if

applicable)

Project evaluation plan - M3

Year one evaluation report – M12

Year two evaluation report – M24

Project evaluation report – M30+2

WP specific

objective relevant

to WP (see Annexe

1a, WP3, evaluation

strategy, p38-40.

Note objective

numbers do not

relate to WP

number).

List title and

number:

As stated above – objective to review progress on targets

Objective indicators

(see Annexe 1a,

WP3, evaluation

strategy, p38-40)

List process

indicators, output

indicators and

outcome indicators

relevant to this WP.

None

Plans of action for Project Evaluation has three components: process, output and outcomes as

listed in the section above. Process indicators are closely linked with project

17

achieving objectives

and indicators

(i.e. what are you

going to do to

achieve the process,

output and

outcomes

indicators?)

coordination and require the successful and timely completion of workshops,

meetings and reports. Output indicators require both quantitative and

subjective analysis both by internal (i.e. ASHT working group) and external

(stakeholders & collaborating partners). Measuring the amount of data

mined in the project (re: WP5/7b) is quantitative and can be achieved by the

project group. Subjective analysis of work-package reports requires an

external expert opinion which will be sought from external stakeholders.

Comments and feedback from stakeholders will be captured in the

evaluation strategy. Recommendations made by evaluators and agreed by

the project group will be incorporated into the project outputs where

possible. This process will add greater impartiality to the review process and

reinforce the integrity of the project outputs.

Stakeholders for

WP, objectives,

indicators.

Process indicators – Project group

Output indicators – Project group for quantitative measures; External

Stakeholders & collaborating partners (where appropriate) for subjective

review.

Outcome indicators – Project group and external stakeholders

Target audience, for

outcomes of WP

(see Annexe 1a,

WP2, p36)

Public

Distribution channel

and method (e.g.

see Annexe 1a, WP2,

p36)

Reports of outcomes to EAHC (2 copies) and project website

Working

arrangements for

the WP (e.g. WP

specific TCs, working

group, email group,

meetings planned,

frequency of

meetings, etc.)

Discussions will take place via email and monthly evaluation TCs with the

project group. HPA Coordination of the project will also be managed under

the ISO9001 Quality Management System.

External experts for specific WP evaluation tasks will be sought and asked to

join specific workshops and review WP outputs. These might include: Joanna

Tempowski - WHO (WP4, CEMM report review), Hugo Kupferschmidt – ZPC

(WP5&WP7b Data Mining), Irma de Vries - EAPCCT (WP6 Network of

Experts); Nick Bateman – NPIS (WP7a Toxidrome Tool)

Stakeholder Consultations will be coordinated by HESC via an online

consultation system and during the EAPCCT congresses.

Other relevant

information for the

WP

Sheet Version: v0.1

Date: 03/07/12

18

ASHTIII Work Packages Co-ordination Plans

Work package name

and number

WP 4: Development and evaluation of standardised chemical casualty

medical management sheets

WP lead GUH- Daniela Pelclova

Supported by Sergey Zakharov, Tomas Navratil

WP description

(from Annexe 1a

and 1b)

To develop standardized documentation for the clinical management of chemical casualties. The use of coded terminology will be evaluated in order to develop a harmonised multi-lingual approach to the provision of standardized health care for chemical casualties.

This work-package builds upon the successful completion of ASHTII work-

package 6 in standardizing the terminology used to report clinical effects for

incorporation into RAS-CHEM so that the system adopts a multi-lingual

approach to describing the symptoms of toxic exposures in humans. WP4 of

this project seeks to address a concern expressed in the EU funded Mass

casualties and health care following the release of toxic chemicals or

radiological materials (MASH) project (EU project: 2007/209). One conclusion

of the project was that standardized EU patient medical management sheets

are required to improve the EU risk management of chemical exposure. The

ASHTIII project group has many years experience in developing patient

medical management sheets from peer-reviewed literature; this work-

package seeks to model the best practice advice for the management of

patients of chemical exposure using coded terminology. The work will be

peer-reviewed by EU clinical toxicologists and evaluated for inclusion in RAS-

CHEM. The initial tranche of the Chemical Casualty Medical Management

System (CEMM) sheets will at least in part mirror the agents identified for

inclusion in RAS-CHEM in ASHTII/ASHTI. This work-package also builds on the

outputs of the CARIMEC service contract. The lead partner for WP4 will be

GFH with support from HESC, HPA, and a sub-contractor. The other project

partners will be mainly involved in the development and review of the CEMM

sheets and the work-package report. GFH led ASHTII WP6 and, due to the

similarities between these work-packages, their expertise will be invaluable

in developing this work-package. The sub-contractor will provide expert

knowledge on the development of the CEMM sheets from bespoke

toxicological patient management databases, such as the UK Toxbase. The

sub-contractor will be identified applying national public procurement rules

and procedures and will be expected to have expertise in clinical toxicology

and experience of and access to bespoke toxicological patient management

databases (e.g. UK Toxbase).

Associate Partners

(institutions and

named individuals)

UMG-GOE, HESC, GFH, NHI (ISS), CHRU de Lille, NPIC, HPA (NPIS)

Collaborating

partners

(institutions and

EAPCCT, WHO (Europe), WHO (Geneva), AAPCC, Poisons Information Service

(Ireland), Department of Health (UK), Health Ministry (France), Health

Ministry (Germany), Health Ministry (Czech Republic), Centro de Informacao

19

named individuals Antiveneos, ECHA

Deliverables:

(from Annexe 1a)

4 - Medical Management Sheet Report - A report outlining the benefits of

providing a common approach to treatment of chemical casualties. The

report will include examples of these sheets for incorporation into RAS-

CHEM.

Milestones:

(from Annexe 1a)

Deadlines:

(including draft

report deadlines if

applicable)

1 – WP4/WP5 Workshop in Rome Month 9

2 – EAPCCT Congress Satellite Meeting WP4 Discussion Month 12

3 - Medical Management Sheet Report Month 26

(Draft deadline: 3- Month 25)

WP specific

objective (SO)

relevant to WP (see

Annexe 1a, WP3,

evaluation strategy,

p38-40. Note objective

numbers do not relate to WP

number).

List title and number:

SO 2: Standardised chemical casualty medical management sheets

SO 3: Harmonized product information relating to pesticides and biocides

Objective indicators

(see Annexe 1a, WP3,

evaluation strategy,

p38-40)

List process

indicators, output

indicators and

outcome indicators

relevant to this WP.

SO 2:

Process indicator: WP4/WP5 workshop in year 1 to agree on data fields and

structure of CEMM sheets.

Output indicator: Agreement of data fields and structure of CEMM sheets.

Outcomes indicators: Increased number of standardised data sheets for

public health management of high risk chemicals.

Process indicator: CEMM Sheet work-package report submission in M26

Output indicator: External expert peer review of report.

Outcomes indicators: Faster and more efficient access to harmonised

guidance on managing chemical incidents.

SO 3:

Process indicator: EAPCCT Congress Satellite Meeting WP4 Discussion in year

2/3 at least 10 completed questionnaires.

Output indicator: Discussion and agreement on the use of automated data

mining for biocide and pesticide reporting

Outcomes indicators: Increased number of EU PC aware of data mining for

biocide/pesticide reporting

Process indicators: External stakeholder consultation on use of RAS-CHEM

for biocide +pesticide reporting by M17. Responses from at least 10 different

member state competent authorities.

Output indicator: Improved understanding of the issues and challenges

20

involved in automated data mining of biocide and pesticide data,

Outcomes indicators: Increased number of EU MS competent authorities

aware of data mining for biocide/pesticide reporting and RAS-CHEM.

Process indicators: Pilot study (linked to WP5/7 and objective 5) on use of

data mining to capture biocide and pesticide exposure data

Output indicator: Automated mining of biocide/pesticide exposure data

from at least 4 EU PCs over at least 3 months to demonstrate proof of

principle.

Outcomes indicators: Faster and more efficient mechanism capture

standardised pesticide and biocide of exposures data.

Process indicators: WP4 Report submission

Output indicator: External expert peer review of report

Outcomes indicators: Faster and more efficient mechanism capture for

reporting of biocide and pesticide exposures by EU PCs and MS competent

authorities.

Plans of action for

achieving objectives

and indicators

(i.e. what are you

going to do to

achieve the process,

output and

outcomes

indicators?)

SO2: During M1-6 we will produce CEMM sheets of different types of

chemicals, based on the standard form for Chlorine and complex set of

toxicological databases. We will distribute them for discussions about the

structure, level of details, especially in the management part, to know the

opinion of the partners.

After the agreement on the final form of CEMMs, we will work on further set

of CEMMs and send them for the specific peer review of the partners.

SO3: We will present our biocides +pesticides classification in the data

collection and discuss it with other partners. We will then participate in the

data mining of these agents. If agreed, CEMMs of biocides/pesticide will be

produced.

Stakeholders for

WP, objectives,

indicators.

Medics, Public health professionals, risk assessors and managers, emergency

responders, PHA, PC, Ministries of Health, MS and non-EU-MS.

Target audience, for

outcomes of WP

(see Annexe 1a,

WP2, p36)

MS Health Authorities, EU PCC, DG-SANCO, EAHC and public health professionals

Distribution channel

and method (e.g.

see Annexe 1a, WP2,

p36)

Publication of report on findings from consultations on project web-site and

EU journal

Presentations to physicians of emergency medicine and toxicologists in the

Czech Republic and abroad concerning the ASHTIII goals and progress.

Working

arrangements for

the WP (e.g. WP

specific TCs, working

group, email group,

September – November 2012 TC should include CEMMs discussion (M3-5)

December- January 2013 TC should discuss biocides/pesticides choice for

CEMMs (M6-8)

Working group of all partners from different point of view should comment

CEMMs (M6-8)

21

meetings planned,

frequency of

meetings, etc.)

To be discussed in WP4/WP5 Workshop in Rome (February 2012)(M9),

March 2013- May 2013 production of further CEMMs to be discussed at

EAPCCT Congress Satellite Meeting WP4 Discussion (M12)

M 13-21 production of CEMMs

M 22-23 Draft Report formulation

M 24-26 Final Report formulation

As well as using minuted teleconferences to discuss and agree upon the

content and format of the CEMM sheets correspondence via email threads

(to the WP4 working group) will be used. These emails will be captured and

included as appendices in WP reports along with agreed TC minutes.

Other relevant

information for the

WP

Sheet Version: v0.1

Date: 05/08/12

22

ASHTIII Work Packages Co-ordination Plans

Work package name and number

Feasibility study: Can the system enable EU MSs to comply with EU Directives? (WP 5).

WP lead National Institute of Health (Istituto Superiore di Sanità) (NHI-ISS)-Laura Settimi. Supported by Subcontract-National Poison Control Center in Milan (NPCCM)- Franca Davanzo, Fabrizio Sesana, Giovanni Milanesi.

WP description (from Annexe 1a and 1b)

WP 5 is aimed at determining whether further development of RAS-CHEM can enable EU MSs to comply with Article 7 (Points 2 and 3) of Directive 2009/128/EC concerning sustainable use of pesticides, term referred to both plant protection products (PPPs) and biocidal products (BPs), and with Article 65 (Point 3b) of Regulation 2012/528/EU concerning the making available on the market and use of BPs. These legislative acts state that EU MSs shall regularly submit to the Commission the available information on any pesticide-related poisonings and the specific measures taken to mitigate the risk of future cases. In order to support effective reporting at national and European level, Directive 2009/128/EC specifically requires that EU MSs shall put in place systems for gathering comparable data on acute poisoning incidents involving pesticides.

Associate Partners (institutions and named individuals)

UMG-GOE (Herbert Desel, Andreas Schaper); HESC (Gabija Dragelyte, Robertas Badaras); GUH (Daniela Peclova, Sergey Zakharov); CHRU de Lille (Monique Mathieu-Nolf); PIN (Erik Andrews); HPA (Raquel Duarte-Davidson; Helen Crabbe; Rob Orford).

Collaborating partners (institutions and named individuals

EAPCCT (Irma de Vries, Simon Thomas); AAPCC (Al Bronstein); WHO (Geneva) (Joanna Tempowski); Swiss Toxicological Information (Hugo Kupferschmidt); Department of Health (UK) (Simon Dyer); Ministry of Health (Czech Republic); Ministry of Health (Germany); Ministry of Health (France); National Poisons Information Centre of Ireland (Edel Duggan); MeDRA (Eva Rump); MTIS; CEFIC (Chris Money); EUPHA; InVs (France).

Deliverables: (from Annexe 1a) Deadlines: (including draft report deadlines)

A report highlighting how the RAS-CHEM system can be utilised by PCs to enable them to meet EU Directive 2009/128/EC and Regulations on reporting PPPs and BPs poisoning exposures; including how this process will enable sustained and long term use of RAS-CHEM.

24th September 2014 (m 28)

Draft due 27th August 2014 (m 27)

Milestones: (from Annexe 1a)

Deadlines: (including draft report deadlines if

1. Consultation and development of standardised product classification (PPPs and BPs) (linked to WP2 & WP3); 2. Pilot study (linked to WP7 - Pesticide/Biocide Data Capture Report; 3. Evaluation of pilot study and submission of work package report; 4. EAPCCT Congress Satellite Meeting WP5 Discussion; 5. EAPCCT Congress Satellite Meeting WP5 Discussion. (1) 30th October 2013; (2) 28th May 2014; (3) 24th September (2) 2014; (4) 28-31th May 2013; (5) May 2014.

23

applicable)

WP specific objective relevant to WP (see Annexe 1a, WP3, evaluation strategy, p38-40. Note objective numbers do not relate to WP number). List title and number:

Specific objective 3: Harmonised Product Information Relating to Plant Protection Products (PPPs) and Biocidal Products (BPs)

Objective indicators (see Annexe 1a, WP3, evaluation strategy, p38-40) List process indicators, output indicators and outcome indicators relevant to this WP.

Process indicator 3a: EAPCCT congress satellite WP5 discussion in year 2/3 at least 10 completed questionnaires; Output indicator 3a: discussion and agreement on the use of automated data mining for PPPs and BPs; Outcome indicator 3a: Increased number of EU PCs aware of data mining for PPPs and BPs reporting. Process indicator 3b: External stakeholder consultation on use of RAS-CHEM for PPPs and BPs reporting. Responses from at least 10 different MS competent authorities. Output indicator 3b: improved understanding of the issues and challenges involved in automated data mining of PPPs and BPs data; Outcome indicator 3b: Increased number of EU MSs competent authorities aware of data mining for PPPs/BPs reporting and RAS-CHEM. Process indicator 3c: Pilot study on use of data mining to capture PPPs/BPs exposure data; Output indicator 3c: automated data mining of PPPs and BPs exposure data from at least 4 EU PCs over at least 3 months to demonstrate proof of principle; Outcome indicator 3c: Faster and more efficient mechanism for standardised capture for reporting of PPPs and BPs exposure data; faster and more efficient capture mechanism for reporting of PPPs and BPs exposures by EU PCs and MSs competent authorities. Process indicator 3d: WP5 Report submission; Output indicator 3d: External expert peer review of report.

Plans of action for achieving objectives and indicators (i.e. what are you going to do to achieve the process, output and outcomes indicators?)

1. Development of a methodology for PCs to harmonise product information taking into account the indication provided by Regulation 2009/185/EC concerning statistics on pesticides (Annex III, harmonised classification of substances, specifically referred to PPPs), and Regulation 2012/528/EU (Annex V, Biocidal product-types). 2. Development of a proposal for a European standardised reporting procedure for PPPs- and BPs-related poisonings to be submitted to the Commission and EU MSs as contribution to the development of a strategic

24

guidance document on monitoring and surveying of impact of pesticide use on human health according to Directive 2009/128/EC; 3. Development of criteria to identify poisoning cases to be selectively reported to RAS-CHEM; on that basis, development of an automated data mining system to be applied to PCs database; 4. Verify the possibility that data on PPPs- and BPs-related poisonings as reported to RAS-CHEM could be used by the Environmental Chemical Agency (ECHA) as a source of information for revision and classification of pesticides.

Stakeholders for WP, objectives, indicators.

Associated partners, Collaborating partners, EU MSs PCs.

Target audience, for outcomes of WP (see Annexe 1a, WP2, p36)

DG-SANCO, Executive Agency for Health and Consumer (EAHC), European Commission’s Health Security Committee (ECHSC), European Chemical Agency (ECHA), EU MSs authorities, EU PCs.

Distribution channel and method (e.g. see Annexe 1a, WP2, p36)

Publication of reports on findings from consultation on project web-site and EU journal.

Possible peer reviewed article in EU journal on pilot study.

Working arrangements for the WP (e.g. WP specific TCs, working group, email group, meetings planned, frequency of meetings, etc.)

Each month is planned a meeting with PC in Milan (sub-contractor); monthly consultation of WP 2 & 3; two meetings per year with collaborating and associated partners in order to plan and carry out a pilot study on use of data mining to capture PPPs/BPs exposure data; two EAPCCT congress satellite meetings WP5 discussion.

Other relevant information for the WP

Sheet Version: v0.1 Date: 03/07/12

25

ASHTIII Work Packages Co-ordination Plans

Work package name and number

WP6: Feasibility study: is developing a network of experts a robust approach to increase global health awareness?

WP lead Monique Mathieu-Nolf, CHRU-Lille

WP description (from Annexe 1a and 1b)

The US National Poisons Database System (NPDS) is continually monitored by

a pool of medical and clinical toxicologists to evaluate for anomalies reported

to the system; these anomalies include cyanide, ricin, botulism, nerve gas

exposures to name but a few. Validated threats are followed up through the

reporting to poisons control centres and the necessary public health

response taken. This work package seeks to evaluate how such an approach

could be developed within the EU to monitor and assess ongoing incidents of

cross border public health concern to complement the work of the DG-

SANCO Health Emergency Operations Facility. This validation process is

intrinsic to the successful operation of RAS-CHEM and the link between the

risk assessment (EU Poison Centres) and risk management (National Public

Health Offices) tiers of the platform. This work package will also explore and

assess how events reported to RAS-CHEM will be effectively communicated

to other EU RAS systems and sectors within the Commission. This work will

build upon ASHTII that described the mechanisms to alert National MS

Authorities from the Poisons Centre level. It also interlinks with the work

carried out under the CARIMEC [20106122] project (deliverables 1-4 & 5),

which seek to define the existing mechanisms to communicate information

regarding chemical (& radiological) events to the World Health Organization

(WHO) and MS authorities via other EU notification systems. Understanding

how best to provide expert toxicological input regarding transboundary

chemical incidents and how this knowledge would add to inter-sectoral

responses and preparedness is key to the success of the WP. Outputs from

this work package will be important for the successful implementation of the

Risk Assessment Network identified in the CARRA-NET service contract and

also outlined in the 2012 call for projects. It is clear that the risks represented

by chemical health threats are diverse and therefore require a dynamic

response to provide expert guidance on mitigating these risks. Expert

medical countermeasure and public health advice is also important for the

preparedness and responsiveness of other sectors in responding to health

threats; understanding how this advice may be disseminated appropriately is

key. WP6 is linked to the discussions, evaluation of use of automated data-

mining (work package 7). The work strongly benefits from the inclusion of the

European Association of Poisons Centres and Clinical Toxicologists (EAPCCT),

the American Association of Poisons Control Centres (AAPCC) and the World

Health Organisation as collaborating partners. Lessons learned from the

development and successful implementation of NPDS by the AAPCC will be

applied to both WP6 and WP7a.CHRU-Lille will lead this work-package due to

their knowledge and experience in working on international committees

regarding toxic exposures and also their past involvement in ASHTII. HPA will

also support this work-package due to their previous leading role in ASHTII

WP5. The remaining project partners and will also be key in the development

of this work-package including discussions with external stakeholders and

26

reviewing WP outputs.

Associate Partners (institutions and named individuals)

HPA, UMG-GOE, HESC, GFH, NHI (ISS), CHRU de Lille, PIN

Collaborating partners (institutions and named individuals

EAPCCT, AAPCC, WHO (Geneva), Swiss Toxicological information, Ministry of

health (Czech Republic), InVS, Ministry of Health (France), Ministry of health

(Germany), National poison centre (Ireland)

Deliverables: (from Annexe 1a) Deadlines: (including draft report deadlines)

Network of experts report: An evaluation report of the feasibility study of

establishing a “network of experts” to monitor and review data posted to

RAS-CHEM.

2014 July (M26)

Draft deadline -June 2014 (M25)

Milestones: (from Annexe 1a)

Deadlines: (including draft report deadlines if applicable)

EAPCCT Congress Satellite Meeting WP6 Discussion - M12 (May 2013) Discussion Session at Interim Meeting – M15 (September 2014) WP6 Report Submission – M26 (July 2014)

WP specific objective relevant to WP (see Annexe 1a, WP3, evaluation strategy, p38-40. Note objective numbers do not relate to WP number). List title and number:

Clinical Toxicology EU Assessment Network: To conduct a feasibility study to determine whether a ‘network of clinical toxicology experts’ is an appropriate mechanism to monitor and review data posted to RAS-CHEM.

Objective indicators (see Annexe 1a, WP3, evaluation strategy, p38-40) List process indicators, output indicators and outcome indicators relevant to this WP.

Questionnaires (at least 20) from expert toxicologists (at least 15) and Health authorities (at least 5) External expert peer review of report

Specific Objective 4 Clinical Toxicology EU Assessment Network

Process indicators Output Indicators Outcomes indicators

EAPCCT congress satellite work package 6 discussions in year 2/3. number of attendees at satellite meeting and at least 10 completed questionnaires (per meeting).

Discussion of mechanism for providing expert toxicological input and advice into RAS-CHEM and CEMM sheets

Increased number of EU PCs aware of the requirement for expert toxicological input and review of RAS-CHEM/CEMM sheet data.

WP6 Discussion session at interim meeting. Meeting participation and at least 10

Formulation and agreement of the proposed mechanism to administrate the

Faster and more efficient mechanism to access expert toxicological advice to

27

completed questionnaires.

toxicological content of RAS-CHEM/CEMM sheets to aid chemical incident response of EU MS

review for RAS-CHEM content and CEMM sheet development

WP6 Final Report submission at M26

External expert peer review of report

Faster and more efficient access to expert toxicologists to assess chemical health threats and provide consistent advice to the Commission and EU MSs

Plans of action for achieving objectives and indicators (i.e. what are you going to do to achieve the process, output and outcomes indicators?)

Description and analysis of lessons learned from the development and implementation of existing alert systems using network of experts (US experience, French toxicovigilance system, WHO, EAPCCT)

Description and analysis of expert networks & expert committees established by the Commission for health risk assessment

Description and analysis expert health risk assessment networks established in EU funded projects (FP7&EAHC) i.e. CERACI & CARRANET.

Descriptions of existing networks might include: Role & function (e.g. monitoring, validation of signals, assessment), organisation (how, when, who), cost, legality. The European Poisons Centre and Public Health community will be polled to better understand how such a ‘network’ could exist and the character or competencies of the individuals that could be involved. Geographical Scope of such a network would also be considered in the appraisal. Understanding how such experts fit into the ‘national’ and subsequently the ‘international’ arena via delegated contact points (i.e. IHR contact points or EU Health Security Members will also be considered. The polling process will be executed in conjunction with the WP3 evaluation work-package to ensure the quantitative outputs of the consultations are measured. Discussions and polling will also be taken forward at the annual EAPCCT congress which is well attended by European PCs and Public Health Professionals.

Stakeholders for WP, objectives, indicators.

MS Health authorities, EU poisons centres, DG SANCO, EAHC and public health professionals

Target audience, for outcomes of WP (see Annexe 1a, WP2, p36)

MS Health authorities, EU poisons centres, DG SANCO, EAHC and public health professionals

Distribution channel and method (e.g. see Annexe 1a, WP2, p36)

Distribution Channel: Publication of report on findings from consultation on project web-site and EU journal.

Target Audience: MS Health Authorities, EU Poisons Centres, DG-SANCO, EAHC and public health professionals

28

Working arrangements for the WP (e.g. WP specific TCs, working group, email group, meetings planned, frequency of meetings, etc.)

A work package working group will be agreed to help draft and formulate the scope of the consultation and WP report. HESC will lead the consultation process via WP3 using online consultations and a electronic debating system at the EAPCCT congresses

WP specific teleconferences and group emails will be used to coordinate the actions of the WP working group.

Workshop in 2013 (year 2)

Other relevant information for the WP

Linked with WP3

Sheet Version: v0.1 Date: 03/07/12

29

ASHTIII Work Packages Co-ordination Plans

Work package name and number

Work package 7: Development and evaluation of EU poisons centre data mining system (7a) and toxidrome matrix tool (7b)

WP lead Universitätsmedizin Göttingen (UMG-GOE), Giftinformationszentrum-Nord (GIZ-Nord Poisons Centre) in Göttingen, Germany- Herbert Desel and Andreas Schaper.

WP description (from Annexe 1a and 1b)

(a) Development, testing and evaluation of an IT based harmonised toxidrome matrix tool (with terms developed in ASHTII) to enable system users in the EU to evaluate reported clinical effects to determine the nature and identity the chemical agent. (b) Further development, testing and evaluation of a data mining tool (initially developed in ASHT II). To explore and evaluate the automated mining of chemical exposure case data in other EU MSs and to describe the issues, both technical and political to achieve and sustain this approach.

Associate Partners (institutions and named individuals)

HESC, Health Emergency Situations Centre Ministry of Health (Lithuania) GFH, General Faculty Hospital (Czech Republic) NHI (ISS), Instituto Superiore di Sanita (Italy) CHRU de Lille, Centre Hospitalier Universitaire de Lille (France) NPIC (Norwegian Poisons Information Centre) HPA, Health Protection Agency (UK)

Collaborating partners (institutions and named individuals

EAPCCT, AACT, WHO (Geneva), Swiss Toxicological Information, Department of Health (UK), Ministry of Health (Czech Republic), Ministry of Health (Germany), Ministry of Health (France), National Poisons Information Centre of Ireland, MeDRA, MTIS, CEFIC, EUPHA

Deliverables: (from Annexe 1a) Deadlines: (including draft report deadlines)

# 3 Toxidrome Matrix Report (month 30) #7 Data Mining Report (month 30) Month 30 (Dec 2014) Draft report deadline: M29 (Nov 2014)

Milestones: (from Annexe 1a)

Deadlines: (including draft report deadlines if applicable)

Month 9: WP 6 / WP 7 Workshop (February 2013 in Rome) M 12: EAPCCT Congress Satellite WP 7a Meeting Discussion M 24: EAPCCT Congress Satellite WP 7b Meeting Discussion M 30 Data Mining Report (WP 7a) M 30 Toxidrome Matrix Report (WP 7b)

WP specific objective relevant to WP (see Annexe 1a, WP3, evaluation strategy, p38-40. Note objective

Specific Objective 1: Toxidrome Matrix Development Specific Objective 5: EU Poisons Centres Data Mining

30

numbers do not relate to WP number). List title and number:

Objective indicators (see Annexe 1a, WP3, evaluation strategy, p38-40) List process indicators, output indicators and outcome indicators relevant to this WP.

(a) Agreement on set of parameters and scope of toxidrome informatics tool (Toxidrome matrix IT tool; WP 7b). External expert peer review of report. Final report to be submitted in M 30. Outcomes indicators: increased number of high risk chemicals detectable using toxidrome analysis. Faster and more efficient identification of high risk chemicals from chemical injuries. (b) Pilot study (linked to WP 5/7 and objective 3) on use of data mining to PC exposure data. EAPCCT congress satellite work package 7 discussions in year 2 and 3. Workshop participation and at least 10 completed questionnaires. Data Mining (WP 7a) report to be submitted in M 30. Output indicators: automated mining of selected PC exposure data from at least 6 EU PCs over at least 6 months to improve upon ASHT II WP 4b outputs. Improved understanding of the issues. Increased number of EU PCs involved in automated data mining of exposure data. lmproved understanding of issues relating to implementation of automated data mining of exposures. External expert peer review of report. Outcomes Indicators: Faster and more efficient methods for PC automated data and stronger harmonised data capture. lncreased number of EU PCs aware of automated data mining of exposure data. Faster and more efficient methods for the harmonised mining and analysis of information related to toxic chemical exposures in the EU.

ASHT III WP 7 a:

Data mining of poisons centre reports on pesticide poisoning cases

Perequisites:

1. Pesticide and biocide product categories from WP 5 (see WP 5 summary) 2. Requirements of case data set according to the European regulations (from WP 5)

Objectives:

Before fulfillment of prerequisites:

1. To implement a developmental version of a case database system, based on ASHT II WP 4b results and ASHT II DRATO RAS CHEM (Developmental version of RAS-CHEM). 2. Pilot Case Data Collection Study (ASHT III PCDC):

To form a group of at least 6 European poisons centres that are ready to submit (small) case datasets using the ASHT II Case Notification Protocol (see ASHT II WP 4b Final Report)

31

To define inclusion criteria for Pilot Case Data Collection Study (PCDC, e.g. for organophosphate-containing and neonicotinoid-containing products)

To support partner centres in preparing the datasets

To collect data from partner centres

After fulfillment of prerequisites:

1. To adapt the ASHT II Case Notification Protocol for reporting biocide and pesticide according to the European regulations 2. To perform the main ASHT III Case Data Collection Study (ASHT III MCDC) o perform all steps from PCDC o analyse dataset for completeness and problems.

ASHT III WP 7 b: Toxidrome Matrix

Starting from Toxidrome list of ASHT II ...

populate toxidrome list with 25 more agents (with references) o include all textbook toxidromes o include selected cases o select agents with latency that may show risk for hidden exposures relate MedDRA symptoms to path of exposure (3 dimensional matrix: organ, time course & severity, path) o inhalation, dermal, eye, oral, all or unknown

classify local, primary systemic effects, secondary systemic effects

evaluate symptoms for their specificity

specific effects give better guidance than non specific effects

Plans of action for achieving objectives and indicators (i.e. what are you going to do to achie-ve the process, out-put and outcomes indicators?)

(a) WP6/WP7 Workshop in year 1 attended by project group (b) EAPCCT congress satellite work package 7 discussions in year 2 and 3.

Stakeholders for WP, objectives, indicators.

MS Health Authorities, EU Poisons Centres, DG-SANCO, EAHC and public health professionals

Target audience, for outcomes of WP

MS Health Authorities, EU Poisons Centres, DG-SANCO, EAHC and public health professionals

32

(see Annexe 1a, WP2, p36)

Distribution channel and method (e.g. see Annexe 1a, WP2, p36)

Publication of report on findings from consultation on project website and EU journal

Working arrangements for the WP (e.g. WP specific TCs, working group, email group, meetings planned, frequency of meetings, etc.)

WP6/WP7 Workshop in year 1 attended by project group.

WP specific TCs when needed in the process and email group.

Other relevant information for the WP

Sheet Version: v0.1 Date: 03/07/12

Appendix C- Project Timetable

33

1 J

2 J

3 A

4 S

5 O

6 N

7 D

8 J 13

9 F

10 M

11 A

12 M

13 J

14 J

15 A

16 S

17 O

18 N

19 D

20 J 14

21 F

22 M

23 A

24 M

25 J

26 J

27 A

28 S

29 O

30 N

HP

A

WP1

K/O

LU

X

1.C

oo

rd

Pla

n

Inte

rim

M

8.Inte

rim

Report

Fin

al M

9.F

inal

Report

HE

SC

WP2

1.

Dis

sem

Pla

n

EA

PC

CT

EA

PC

CT

HP

A

WP3

2.E

val

Pla

n

Eval

Report

Eval

Report

10.E

va

l

Report

GU

H

WP4 W D

4.R

ep

ort

NH

I(IS

S)

WP5 W

Consult

D Consultation Pilot Study D Pilot

Study

5.R

ep

ort

CH

RU

-

Lille

WP6 D D W

6.R

ep

ort

Appendix C- Project Timetable

34

Key

Deliverable D1 –Co-ordination and Dissemination plan D2 – Evaluation strategy D3 – Toxidrome Matrix Report D4 – Medical Management Sheet Report D5 – EU directive compliance Report D6 – Network of experts Report D7 – Data Mining Report D8 – Interim Report D9 – Final Report D10 – Evaluation Report

Month 3 3

30 26 28 26 30 17 30 30

Meetings & Workshops 1- Kick Off Meeting – 2- WP4/5 Workshop - 3- Interim Meeting - 4- WP6/7 Workshop 5- Final Meeting -

Dates 12-13/06/12 12-13/02/13 24-25/09/13 28-29/01/14 23-24/09/14

Venue Luxembourg Rome, Italy

Vilnius, Lithuania Prague, Czech Republic

Luxembourg

Month 1 9

16 20 28

Dissemination Meeting 1- EAPCCT Congress 2013 2- EAPCCT Congress 2014

Dates 28-31/05/2013

05/2014

Venue Copenhagen, Denmark

Brussels

Month 12 24

WP3 Teleconferences: 1st Wednesday of the month at 10:30am GMT, 11:30am CET, 12.30pm EET.

UM

G-

GO

E

WP7 D W D

3&

7.R

ep

ort

35

Appendix D- Project Milestones

Lead Work Package

Milestone Date (Wednesday) Month

HESC 2 Dissemination Plan 29th August 2012 3

HPA 3 Evaluation Plan 29th August 2012 3

GUH 4 WP4/5 Workshop 27th February 2013 9

HPA 3 Year one evaluation report 29th May 2013 12

HESC 2 EAPCCT Congress Satellite Meeting

28th- 31st May 2013 12

GUH/ NHI (ISS)/ CHRU-Lille/UMG

4/5/6/7 EAPCCT Congress Satellite WP4, 5, 6 and 7 Discussions

28th- 31st May 2013 12

CHRU-Lille 6 Discussion session at interim meeting

24-25th September 2013 15

HPA 1 Interim project report draft 25th September 2013 16

HPA 1 Interim project report 30th October 2013 17

NHI (ISS) 5 Consultation and development report of standardised product classification

30th October 2013 17

CHRU-Lille/ UMG

6/7 WP6/7 Workshop 27-28th January 2014 20

HESC 2 EAPCCT Congress Satellite Meeting

May 2014 24

NHI (ISS)/UMG

5/7 EAPCCT Congress Satellite WP5 and WP7 Discussions

May 2014 24

HPA 3 Year two evaluation report 28th May 2014 24

NHI (ISS) 5 Pilot Study 28th May 2014 24

GUH 4 Medical Management Sheet Report

30th July 2014 26

CHRU-Lille 6 WP6 report submission 30th July 2014 26

NHI (ISS) 5 Work Package Report 24th September 2014 28

HESC/HPA 2&3 Draft Project Evaluation Report 29th October 2014 29

HPA 1 Final project report draft 29th October 2014 29

HESC/HPA 2&3 Project Evaluation Report 26th November 2014 30

UMG 7 WP7a Data Mining Report and WP7b Toxidrome Matrix Report

26th November 2014 30

HPA 1 Final project report 26th November 2014 30