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.
Agenda of the EUROmediCAT Steering Group Meeting, London (September 29th –
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).
Agenda of the EUROmediCAT Steering Group Meeting, London (September 29th –
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).
Agenda of the EUROmediCAT Steering Group Meeting, London (September 29th –
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
11:45-12:30 – Panel discussion
Agenda of the EUROmediCAT Steering Group Meeting, London (September 29th – 30th)
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
14:45-15:30 – Panel discussion
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
16:45-17:30 – Panel discussion
Agenda of the EUROmediCAT Steering Group Meeting, London (September 29th – 30th)
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
09:45-10:30 – Panel discussion
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
11:45-12:00 – Panel discussion
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
??
Agenda of the EUROmediCAT Steering Group Meeting, London (September 29th – 30th)
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)
[email protected] July 11th
Dr. Ineke Crijns Panel Prevention of Exposure to Teratogenic drugs (Session 5)
[email protected] July 8th
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)
Agenda of the EUROmediCAT Steering Group Meeting, London (September 29th – 30th)
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
Agenda of the EUROmediCAT Steering Group Meeting, London (September 29th – 30th)
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
Academisch Ziekenhuis Groningen
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.
Agenda of the EUROmediCAT Steering Group Meeting, London (September 29th – 30th)
Appendix 3: Deliverables and milestones WP 3 Del./ Mile. no.
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
Academisch Ziekenhuis Groningen
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
Academisch Ziekenhuis Groningen
32 01/10/2014 Not
submitted Same reasons as above
M9 Protocol for WP3 Academisch Ziekenhuis Groningen
6 29/06/2012 (4) Achieved
Appendix 4: Deliverables and milestones WP 4
Del./ Mile. no.
Deliverable name Lead beneficiary Delivery date from
Annex I (project month)
Actual / Forecast delivery date dd/mm/yyyy (month)
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
Agenda of the EUROmediCAT Steering Group Meeting, London (September 29th – 30th)
Appendix 5: Deliverables and milestones WP 5 Del./ Mile. no.
Deliverable name Lead
beneficiary
Delivery date from Annex I
(project month)
Actual / Forecast delivery date
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
D20 Peer review paper on risk of CA in
relation to SSRI Use: case malformed control design
University of Ulster
36 (Deferred to month 46)
31/12/2014 Not
submitted
D21 Peer review paper on risk of CA in
relation to SSRI use: Population linkage design
Swansea University
42 Moved to 39
31/08/2014 Not
submitted
D22 Peer review paper on risk of CA in
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.
Appendix 6: Deliverables and milestones WP 6
Del./ Mile. no.
Deliverable name Lead
beneficiary
Delivery date from Annex I
(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
Agenda of the EUROmediCAT Steering Group Meeting, London (September 29th – 30th)
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.
Deliverable name Lead
beneficiary Delivery date from Annex I
Actual / Forecast delivery date
Status Comments
Agenda of the EUROmediCAT Steering Group Meeting, London (September 29th – 30th)
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.
University of Ulster
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
University of Ulster
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)
Appendix 8: Deliverables and milestones WP 8 Del./ Mile. no.
Deliverable name Lead beneficiary Delivery date from
Annex I (project month)
Actual / Forecast delivery date dd/mm/yyyy (month)
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