Work Package meetings - ambiente-salute.itHildrun Sundseth Chair Recommendations for reproductive pharmacovigilance in Europe (session 7) [email protected] July 18th Hildrun

Agenda of the EUROmediCAT Steering Group Meeting, London (September 29th –

30th)

Hotel recommendations: No particular order

1. Holiday Inn Express London, 275 Old Street, London EC1V 9LN, (+44)(0)20 7300 4300

2. Thistle City Barbican Hotel, Central St, Clerkenwell, London, EC1V 8DS, (+44)(0)871 376 9004

September 29th, 2014, London Location: Wolfson Institute of Preventive Medicine, Charterhouse Square, London.

Work Package meetings WP2: Signal Detection 08:30 – 11:00

Attendants: Helen Dolk, Joanne Given, Lolkje de Jong-van den Berg, Maria Loane, Michiel Luteijn,

Joan Morris

WP3: Data linkage 11:30 – 13:00

Attendants: Marian Bakker, Linda de Jong (to be confirmed) Sue Jordan, Kari Klungsoyr, Maria Loane,

Michiel Luteijn, Joan Morris, Amanda Neville (phone?), Anna Pierini, Anne Vinkel-Hansen

Apologies: Ester Garne

Discussion of the outline of a paper based on the prx data linkage experience and future plans of these registries.

WP5: Asthma population cohort linkage 14:00-16:00

Attendants: Helen Dolk, Sue Jordan (+ other Wales?), Kari Klungsoyr, Joan Morris, Anne Vinkel-

Hansen

Discussion of the draft versions of the 2 papers and the final conclusions.

WP5: SSRI population cohort linkage 16:00-18:00

Attendants: Gareth Davies, Sue Jordan, Michiel Luteijn, Joan Morris, Anne Vinkel-Hansen, Kari

Klungsoyr, Helen Dolk

Diner September 29th Venue and time to be confirmed.


30th)

September 30th, 2014, London Location: Wolfson Institute of Preventive Medicine, Charterhouse Square, London.

EMSG 08:30 – 16:30 Attendants: Marian Bakker (UMCG), Rachel Charlton (Bath), Helen Dolk (Ulster), Lolkje de Jong-van den

Berg (RUG), Sue Jordan (SU), Kari Klungsoyr (Norway), Anna Latos-Bielenska (PUMS), Maria Loane

(Ulster), Michiel Luteijn (Ulster), Joan Morris (QMUL), Anna Pierini (IFC-CNR), Marlene Sinclair (Ulster),

Anne Vinkel-Hansen (replacing Ester Garne; LIL)

1. Apologies Ester Garne (LIL)

2. Minutes of the last Steering Group Meeting (March 4th, Pisa)

Action no

Nature of action Who

1 EMSG members to add names to EUROmediCAT workshop mailing list by July 4th

EMSG members

2 Michiel to write Rachel and Marlene in order to obtain reports (suitable for EC reporting) for deliverables 24 and 30

Michiel

3 Michiel to design cover sheet suitable for EC reporting Michiel 4 Lolkje, Marian and Rachel to report back on financial situation to Ulster. Lolkje, Marian

and Rachel 5 Michiel to contact Reproductive Toxicology about the possibility of

publishing conference abstracts in their journal. The cost of publishing (if any) should also be discussed.

Michiel

6 All EMSG members to suggest invited speakers/guests by July 4th EMSG members

3. Progress per work package

3.1 WP1 Coordination and project management Future funding Deliverable reports for reporting to EC Policy brief European Commission in cooperation with EIWH Deliverable 6: Documented Study Archive (November 30th, 2014).

3.2 WP8 Dissemination workshop Draft of the agenda plus invited speakers are attached in Appendix I and II. Deliverable 33: Paper: Recommendations for pharmacovigilance for medication safety in pregnancy (January 31st, 2015).

3.3 WP2 Central database and software development Deliverable 8 due: Fully documented EUROmediCAT database ready for future Pharmacovigilance studies (April 30th, 2014). Deliverable 9 due: Pharmacovigilance data summary software (August 31st, 2014). Deliverable 10: Pharmacovigilance data summary/paper (November 30th, 2014).


30th)

Late pregnancies exposures in EUROCAT/EUROmediCAT database

3.4 WP3 Prescription data linkage Deliverable 12 due: Prescription linkage report available for dissemination within consortium (July 1st, 2014). Deliverable 13: Scientific paper on methodology and results of prescription data linkage (October 1st, 2014).

3.5 WP4 AED and Anti-diabetics Deliverable 15: Peer reviewed paper on the risk of specific congenital malformations in relation to new AEDs (October 1st, 2014). Deliverable 16: Peer reviewed paper on the risk of specific congenital malformations in relation to new AEDs (December 1st, 2014). Deliverable 17 due: Peer reviewed paper reporting the results of the diabetic cohort study (June 1st, 2014). Diabetic cohort study meeting

3.6 WP5 Anti-asthmatics and SSRIs Deliverable 19 due: Peer review paper on risk of CA in relation to Anti-asthmatic use: Case-malformed control design (June 28th, 2014). Deliverable 20: Peer review paper on risk of CA in relation to SSRI Use: case malformed control design (December 31st, 2014). Deliverable 21 due: Peer review paper on risk of CA in relation to SSRI use: Population linkage design (August 31st, 2014). Deliverable 22 due: Peer review paper on risk of CA in relation to anti-asthmatic use: Population linkage design (August 31st, 2014).

3.7 WP6 Medication utilisation studies Deliverable 25 due: Report and paper: effectiveness of PPPs through Europe (June 30th, 2014). Deliverable 27 due: Report and paper: use of anticonvulsant medicines in pregnant women in Europe (June 30th, 2014). Deliverable 28 due: Report and paper: Use of anti-diabetic medicines in pregnancy in Europe (September 30th, 2014). Deliverable 29 due: Report and paper: Use of asthma medications in pregnancy in Europe (June 30th, 2014).

3.8 WP7 Internet use & Medication safety Deliverable 31 due: Paper: The implications of internet use by pregnant women for drug safety recommendations: Results from internet survey/focus groups (July 31st, 2014).


30th)

4. Any other business

5. Date and place next meeting The next meeting will be the Poznan conference February 2nd-4th, 2015.

Agenda of the EUROmediCAT Steering Group Meeting, London (September 29th – 30th)

Appendix I: Agenda Poznan February 2nd – 4th, 2015

EUROmediCAT Poznan Conference

Day 0 (Feb 2nd) Geoff Adams-Spink presentation

Lolkje de Jong-van den Berg presentation

Presentation EU representative

Day 1 (Feb 3rd)

9:00-10:30 Session 1: Antidiabetics in pregnancy

Chair: Gerard Visser, [International diabetes federation]

Panel: Margery Morgan, Gerard Visser, Ewa Wender-Ozegowska, [International diabetes federation]

9:00-9:15 – EUROmediCAT antidiabetic drug utilisation in pregnancy

9:15-9:45 – EUROmediCAT presentation risk of congenital anomalies in relation to antidiabetic use

9:45-10:30 – Panel discussion

11:00-12:30 Session 2: Antiepileptics in pregnancy

Chair: Renzo Guerrini, Jim Morrow, [Patient organisation]

Panel: John Craig (EURAP), Renzo Guerrini, Sarah Mee, Jim Morrow, [Patient organisation]

11:00-11:15 – EUROmediCAT antiepileptic drug utilisation in pregnancy

11:15-11:45 – EUROmediCAT presentation risk of congenital anomalies in relation to antiepileptic use



14:00-15:30 Session 3: Antidepressants in pregnancy

Chair: Saena Arbabzadeh-Bouchez, [Patient organisation]

Panel: Saena Arbabzadeh-Bouchez, Heli Malm, Irene Petersen, [Patient organisation]

14:00-14:15 – EUROmediCAT antidepressant drug utilisation in pregnancy

14:15-14:45 – EUROmediCAT presentation risk of congenital anomalies in relation to antidepressant use


16:00-17:30 Session 4: Antiasthmatics in pregnancy

Chair: Vibeke Bakker, [Patient organisation]

Panel:

16:00-16:15 – EUROmediCAT antiasthmatic drug utilisation in pregnancy

16:15-16:45 – EUROmediCAT presentation risk of congenital anomalies in relation to antiasthmatic use



Day 2 (Feb 4th)

09:00-10:30 Session 5: Prevention of exposure to teratogenic drugs

Chair: Vincenzo Bettoli, [Patient Organisation/ Geoff?]

Panel: Vincenzo Bettoli, Rachel Charlton, Christof Schaefer, Laura Yates, [Patient Organisation/ Geoff?]

09:00-09:30 – Marlene Sinclair; Use of Internet

09:30-09:45 – Rachel Charlton; Work Package 6 PPP paper


11:00-12:00 Session 6: Methodology of reproductive Pharmacoepidemiology

Chair: Kristina Star, David Prieto

Panel: Sonia Hernandez-Diaz (declined), David Prieto, Kristina Star, [EUDRAVigilance]

11:00-11:15 – Joan Morris/ Michiel Luteijn; Signal detection

11:15-11:30 – Eudravigilance presentation European Medicines Agency

11:30-11:45 – Marian Bakker; data linkage of EUROCAT data with prescription databases


12:00-13:00 Session 7: Recommendations for reproductive pharmacovigilance in Europe

Chair: Hildrun Sundseth

Panel: Kari Furu, Hildrun Sundseth

12:00-12:15 – Hildrun Sundseth; Building a sustainable reproductive pharmacovigilance system

??


Appendix II: Overview of invites and acceptances panel members and other speakers Poznan Name Role Session Email Accepted

Prof. Vibeke Backer Chair Antiasthmatics in Pregnancy (session 4) [email protected] July 7th

Dr. Vincenzo Bettoli Chair Prevention of Exposure to Teratogenic drugs (Session 5)

[email protected] August 22nd

Prof. Renzo Guerini Chair Antiepileptics in Pregnancy (session 2) [email protected] July 8th

Dr. Saena Arbabzadeh-Bouchez

Chair Antidepressants in Pregnancy (Session 3) [email protected]

Dr. Jim Morrow Chair Antiepileptics in Pregnancy (session 2) [email protected] August 11th

Hildrun Sundseth Chair Recommendations for reproductive pharmacovigilance in Europe (session 7)

[email protected] July 18th Hildrun recommended Dr Andrzej Rys email [email protected]

Kari Furu Panel Recommendations for reproductive pharmacovigilance in Europe (session 7)

Communication via Kari Klungsoyr August 5th

Prof. Gerard Visser Chair Antidiabetics in Pregnancy (Session 1) [email protected] July 11th

Dr. Margery Morgan Panel Antidiabetics in Pregnancy (Session 1) [email protected]

July 15th

Prof. Ewa Wender-Ozegowska

Panel Antidiabetics in Pregnancy (Session 1) [email protected]

Dr. Sarah Mee Panel Antiepileptics in Pregnancy (session 2) [email protected] August 27th

Dr. John Craig Panel Antiepileptics in Pregnancy (session 2) [email protected]

Dr. Heli Malm Panel Antidepressants in Pregnancy (Session 3) [email protected] August 18th

Dr. Irene Petersen Panel Antidepressants in Pregnancy (Session 3) [email protected] July 7th

Dr. Laura Yates Panel Prevention of Exposure to Teratogenic drugs (Session 5)

[email protected] July 9th

Dr. Christof Schaefer Panel Prevention of Exposure to Teratogenic drugs (Session 5)


Dr. Ineke Crijns Panel Prevention of Exposure to Teratogenic drugs (Session 5)


Dr. David Prieto Chair Methodology of Reproductive Pharmacoepidemiology (Session 6)

[email protected] August 18th

Dr. Sonia Hernandez-Diaz

Panel Methodology of Reproductive Pharmacoepidemiology (Session 6)

[email protected] Reject August 25th

Dr. Kristina Star Panel Methodology of Reproductive Pharmacoepidemiology (Session 6)

[email protected]

https://mail.ulster.ac.uk/owa/redir.aspx?C=jNUSSEFC4ki7WyXo2kSFS_akEj4ygNEIDtMyytC9fneC6lw9Ejx0pGtxrvObQKVyb0S6Ym6OLhI.&URL=mailto%3aAndrzej.RYS%40ec.europa.eu


List of milestones and deliverables per work package – situation as per 2nd periodic report (Feb 28th).

Appendix 1: Deliverables and milestones WP 1 Del./ Mile. no.

Deliverable name Lead beneficiary Delivery date from

Annex I (project month)

Actual / Forecast delivery date dd/mm/yyyy (month)

Status Comments

D1 Website Academisch Ziekenhuis Groningen

6 01/11/2011 (9) In

operation Delay due to summer holiday.

D2 Interim report to

Commission 1 University of Ulster 18 29/10/2012 (20) Submitted

Due 18mts as per Grant Agreement Annex II Part A Section 2, II.4. See

section 4.5.1 for explanation.

D3 Interim report to

Commission 2 University of Ulster 36 28/02/2014 (36) Submitted

D5 Final Report University of Ulster 48 28/02/2015 (48) Not

submitted

D6 Documented Study

Archive University of Ulster 45 30/11/2014 (45)

Not submitted

M1 General consortium

meetings including WP meetings

Academisch Ziekenhuis Groningen

34 02/2012 and 03/2013 Archived One meeting per year. Minutes for

first meeting (month 12) are available on website.

M2 Consortium steering

group meetings Rijksuniversiteit

Groningen 2

03/2011, 09/2011, 02/2012, 09/2012, 10/2012, 02/2013,

06/2013, 10/2013 Archived

Minutes of steering group meetings available on website

Appendix 2: Deliverables and milestones WP 2

Del./ Mile. no.

Deliverable name Lead beneficiary

Delivery date from Annex I

(project month)

Actual / Forecast delivery date dd/mm/yyyy

(month)

Status Comments

D7 EDMPmedi software module University of Ulster 12 Dataset A completed Submitted Software released and in use for Datasets A, B


by 03/02/2012

Dataset B completed by 24/01/2014

Dataset C completed by 21/08/2012

and C.

EDMP Software development was not required for Dataset D.

D8

Fully documented EUROmediCAT database ready for future Pharmacovigilance

studies

University of Ulster 38 30/04/2014 (38) Not

submitted

D9 Pharmacovigilance data

summary software

University of Ulster 42 31/08/2014 (42) Not

submitted

D10 Pharmacovigilance data summary report/paper


45 30/11/2014 (45) Not

submitted

M3 Database manual University of Ulster 20 31/01/2013 Published and available

M4 EDMP software ready

University of Ulster 12 15/02/2012 (12)

In operation

Note that this Milestone is the same as Deliverable 7. See Comments to Deliverable 7.

M5 Dataset A ready University of Ulster 24 28/02/2013 Submitted This information was available for the Berlin

2013 meeting.

M6 Dataset B ready Academisch Ziekenhuis Groningen

24 NA

Due to unforeseen data confidentiality issues, dataset B will be analysed using a distributed database model due to data confidentiality

reasons. All planned analysis will be delivered.

M7 Dataset C ready Rijksuniversiteit

Groningen 24 21/06/2013 Submitted

M8 Dataset D ready Lillebaelt 24 NA

Due to unforeseen data confidentiality issues, dataset D will be analysed using a distributed database model due to data confidentiality

reasons. All planned analysis will be delivered.



Deliverable name Lead beneficiary Delivery date from Annex I

(project month)

Actual / Forecast delivery date

dd/mm/yyyy (month) Status Comments

D11 Prescription linked data Academisch Ziekenhuis Groningen

24 28/02/2014 Submitted

D12 Prescription linkage report available for dissemination

within consortium


26 01/07/2014 Not

submitted

Prescription linkage report delayed due to data confidentiality issues and maternity leave Linda de Jonge (UMCG) – see WP3.

D13 Scientific paper on

methodology and results of prescription data linkage


32 01/10/2014 Not

submitted Same reasons as above

M9 Protocol for WP3 Academisch Ziekenhuis Groningen

6 29/06/2012 (4) Achieved


Del./ Mile. no.




Status Comments

D14 Linked dataset for diabetic cohorts and registers Rijksuniversiteit

Groningen 27 28/02/2014 Submitted

D15 Peer reviewed paper on the risk of specific

congenital malformations in relation to new AEDs Rijksuniversiteit

Groningen 38 01/10/2014

Not submitted

D16 Peer reviewed paper on the risk of specific

congenital malformations in relation to insulin analogues

Rijksuniversiteit Groningen

40 01/12/2014 Not

submitted

D17 Peer reviewed paper reporting the results of the

diabetic cohort study Rijksuniversiteit

Groningen 42 01/06/2014

Not submitted

M10 Protocol for WP4 Rijksuniversiteit

Groningen 6 16/11/2011 (9) Achieved



Deliverable name Lead

beneficiary


(project month)


dd/mm/yyyy (month) Status Comments

D18 Report to CHICOS WP1 regarding potential of birth cohort data for

drug teratogenicity studies

University of Ulster

12 28/02/2012 (12) Submitted

D19 Peer review paper on risk of CA in

relation to Anti-asthmatic use: Case-malformed control design

Region Syddanmark

36 28/06/2014 Not

submitted


relation to SSRI Use: case malformed control design


36 (Deferred to month 46)

31/12/2014 Not

submitted


relation to SSRI use: Population linkage design

Swansea University

42 Moved to 39

31/08/2014 Not

submitted


relation to anti-asthmatic use: Population linkage design

Region Syddanmark

42 Moved to 39

31/08/2014 Not

submitted

M11 Protocol for WP5 Lillebaelt 6 31/01/2012

Protocol for the CHICOS study available and report available (Deliverable 18). Protocols for the other studies in WP5 have been delayed

till Month 27.


Del./ Mile. no.


beneficiary


(project month)

Actual / Forecast delivery date dd/mm/yyyy

(month)

Status Comments

D23 Spread sheet with

National Guidelines University

of Bath 3 31/05/2011 Submitted

D24 Report and paper on use of healthcare databases

for drug safety in

University of Bath

36 28/03/2014 Submitted Published in Pharmacoepidemiology and Drug Safety


pregnancy studies

D25 Report and paper:

effectiveness of PPPs through Europe

University of Bath

18 30/06/14 Not submitted Problems with data availability- See Section 3.5.3.

Amendments have been agreed and the study is on-going.

D26

Report and paper: use of antidepressant medicines

in pregnancy women in Europe

University of Bath

18 15/12/2013 Submitted

D27

Report and paper: use of anticonvulsant medicines

in pregnant women in Europe

University of Bath

24 30/06/2014 Not submitted Manuscript is undergoing Steering Group review and will be ready prior to being submitted to a peer-reviewed journal.

D28 Report and Paper: Use of anti-diabetic medicines in

pregnancy in Europe

University of Bath

30 30/09/2014 Not submitted This has swapped places with deliverable 29.

D29 Report and paper: Use of

asthma medications in pregnancy in Europe

University of Bath

36 30/06/2014

Partially achieved; final

report not submitted

Preliminary analysis completed.

M12 Protocol for WP6 University

of Bath 6 28/02/2014 Achieved

Protocols have been developed for the SSRI, AED, Diabetes and asthma medicine utilisation studies as well as for the

pregnancy prevention program study.

Available on website (membership-only).

M15 WP6 Dataset ready University

of Bath 18 31/05/2014 Partial

Instead of collecting one entire dataset before analysis, it was decided to employ a phased approach. The SSRI and AED

dataset is complete. The asthma dataset is still awaiting data from Norway and the Netherlands. The diabetes data will be

extracted by May 2014.

Appendix 7: Deliverables and milestones WP 7 Del./ Mile.


beneficiary Delivery date from Annex I


Status Comments


no. (project month)

dd/mm/yyyy (month)

D30

Paper: The implications of Internet use by pregnant women for drug safety

recommendations: Review of Internet sites selling Isotretinoin.


22 31/10/2012 Submitted Published in Pharmacoepidemiology and

Drug Safety

D31

Paper: The implications of Internet use by pregnant women for drug safety

recommendations: Results from Internet survey/focus groups


36 31/07/2014 Not

submitted

Preliminary results available.

Delay due to problems encountered with recruitment of sample. This led to a slippage of time and a need for a revised timetable.

M13 Protocol for WP 7 (Phase 2) University of

Ulster 12 07/07/2011 (5) Achieved Available on website (membership-only)

M14 Protocol for WP 7 (Phase 3)

University of

Ulster 24 23/07/2012 (17) Achieved Available on website (membership-only)





Status Comments

D32 Dissemination Workshop Uniwersytet Medycnzy Im Karola

Marcinkowskiego w Poznaniu 46 31/12/2014 (46)

Not achieved

D33 Paper: Recommendations for Pharmco-

vigilance for medication safety in pregnancy

Uniwersytet Medycnzy Im Karola Marcinkowskiego w Poznaniu

47 31/01/2015 (47) Not

achieved

M16 Recommendations agreed Uniwersytet Medycnzy Im Karola

Marcinkowskiego w Poznaniu 46 15/12/2014 (46)

Not achieved

Work Package meetings - ambiente-salute.itHildrun Sundseth Chair Recommendations for reproductive pharmacovigilance in Europe (session 7) [email protected] July 18th Hildrun

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