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An agency of the European Union Report from the ENCePP Steering Group, 2017-2020 ENCePP Plenary Meeting, 20 November 2020 Presented by Tom MacDonald Deputy Chair, ENCePP Steering Group
An agency of the European Union
Report from the ENCePP Steering Group, 2017-2020
ENCePP Plenary Meeting, 20 November 2020
Presented by Tom MacDonaldDeputy Chair, ENCePP Steering Group
Classified as internal/staff & contractors by the European Medicines Agency
Key points
• Steering Group in the last four years
• EU PAS Register
• ENCePP documents and publications
• Last words
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Classified as internal/staff & contractors by the European Medicines Agency
Composition of the ENCePP Steering Group 2017-2020
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• One year extension of membership due to Brexit preparedness Business Continuity Plan
• 6 ENCePP members
• 9 appointed representatives
• 1 observer
Classified as internal/staff & contractors by the European Medicines Agency
SG meetings in the last four years
• 14 meetings organised by the ENCePP Secretariat - Reduced activities due to Brexit Business Continuity Plan (BCP), followed by the Covid Business Continuity Plan
• Between November 2018 and April 2020 – 8 general informal SG meetings organised by Rosa Gini (Agenzia regionale di sanità della Toscana), and 3 meetings to discuss the preparation of the general 2019 web meeting
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Classified as internal/staff & contractors by the European Medicines Agency
Some of the key topics of the SG meetings
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Common data models
Governance of pharmacoepide
miology studies
Patient registries initiative ENCePP Code
of Conduct Rev. 4
ISPE Guidelines for good database selection and use in pharmacoepidemiology
research
ENCePP 10 anniversary
Minimalization the impact of Brexit on post-authorisation studies in Europe
Role of ENCePP in supporting
collaborative studies
Benefit/Risk tool tables
(CHMP)
Governance of PE studies
EU Initiatives related to RWE
and RWD
ENCePP Guide on Methodological
Standards revisions 7 and 8
ENCePP SIG on Measuring the
Impact of Pharmacovigilance
Activities
ENCePP SIG Drug Safety in
Pregnancy
Role of ENCePP in the time of Covid; new mandate
Overview of studies entered in the EU PAS
Register
Classified as internal/staff & contractors by the European Medicines Agency
EU PAS Register – Statistics
2017 2018 2019 2020 (until 5 Nov) TOTAL 2011-2020
All new studies (ENCePP partner + others)
251 199 251 264 2155
ENCePP Partner studies*
53 32 52 58 566
Seal studies** 4 8 6 3 63
Covid-related studies
- - - 63 63
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*Also included in “All new studies”**Also included in “All new studies” and “ENCePP Partner studies”
Classified as internal/staff & contractors by the European Medicines Agency
ENCePP Resource Database
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5 78 10
2 2
62*
19
93
0
10
20
30
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50
60
70
2017 2018 2019 2020 (up to 5 November)
ENCePP Resource Database statistics
New ENCePP centres registered New ENCePP networks registered New datasources registered
* Disease registries were introduced by EMA in the database in 2017
Classified as internal/staff & contractors by the European Medicines Agency
EU PAS Register – Upgrade in January 2020
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Classified as internal/staff & contractors by the European Medicines Agency
ENCePP documents published
• Code of Conduct Rev. 4 in March 2018
• ENCePP Checklist for Study Protocols Rev. 4 in October 2018
• ENCePP Guide on Methodological Standards in Pharmacoepidemiology revisions in July 2017 (Rev 6.), July 2018 (Rev. 7) and July 2020 (Rev. 8)
• Rev. 8 - foreword highlights the importance of the Guide for pharmacoepidemiological studies carried-out in the context of the COVID-19 pandemic in order to provide valid results useful for clinicians and regulators
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Classified as internal/staff & contractors by the European Medicines Agency
ENCePP Guide on Methodological Standards in Pharmacoepidemiology – website statistics
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2014-2015(Revision
3)
2015-2016(Revision
4)
2016-2017(Revision
5)
2017-2018(Revision
6)
2018-2019(Revision
7)
2019-2020(Revision
7)*
ENCePP Guide by revision
Downloads Views
*No revision of the Guide took place in July 2019** Revision 8 was published in July 2020
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Jan-20 Feb-20 Mar-20 Apr-20 May-20 Jun-20 Jul-20 Aug-20 Sep-20 Oct-20
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Classified as internal/staff & contractors by the European Medicines Agency
Publications
Xavier Kurz, Susana Perez-
Gutthann, ENCePP Steering Group.
Strengthening standards, transparency,
and collaboration to support medicine
evaluation: Ten years of the European
Network of Centres for
Pharmacoepidemiology and
Pharmacovigilance (ENCePP)
Pharmacoepidemiol Drug Saf.
2018;27(3):245-252.
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https://pubmed.ncbi.nlm.nih.gov/29327451/
Classified as internal/staff & contractors by the European Medicines Agency
Publications
Gini R, Fournie X, Dolk H, Kurz X,
Verpillat P, Simondon F, Strassmann V,
Apostolidis K, Goedecke T. The ENCePP
Code of Conduct: A best practise for
scientific independence and
transparency in noninterventional
postauthorisation studies.
Pharmacoepidemiol Drug Saf.
2019;28(4):422-433
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https://www.ncbi.nlm.nih.gov/pubmed/30838708
Classified as internal/staff & contractors by the European Medicines Agency
Publications
Gini R, Sturkenboom MC, Sultana J, Cave A, Landi
A, Pacurariu A, Roberto G, Schink T, Candore G,
Slattery J, Trifirò G; Working Group 3 of ENCePP.
Different strategies to execute multi-database
studies for medicines surveillance in real world
setting: a reflection on the European model. Clin
Pharmacol Ther. 2020 Apr 3. doi:
10.1002/cpt.1833
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https://www.ncbi.nlm.nih.gov/pubmed/32243569
Classified as internal/staff & contractors by the European Medicines Agency
Covid-related activities
• News item on the ENCePP website on registration of Covid-studies
• Weekly circulation of table of observational studies to ENCePP Partners, PRAC and researchers between March and October 2020
• 218 studies included in the table
• 63 studies registered in the EU PAS Register
• The Covid-related activities were discussed in four SG meetings between April and October 2020
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Classified as internal/staff & contractors by the European Medicines Agency
Update from Working Groups and Special Interest Groups
• ENCePP WG1 - ENCePP research standards and guidances, Alejandro Arana, Xavier Kurz
• ENCePP WG2 - Independence and transparency, Rosa Gini
• ENCePP WG3 - Inventory of EU data sources and methodological approaches for multi-source studies, Gianluca Trifirò
• ENCePP SIG on Measuring the Impact of Pharmacovigilance Activities, Agnes Kant
• ENCePP SIG on Drug Safety in Pregnancy, Corinne de Vries
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Classified as internal/staff & contractors by the European Medicines Agency
Conclusions & Last Words
• ENCePP Has fundamentally changed the landscape of regulatory science research in Europe
• Much has been achieved but innovation a continuous process
• We are all medicines regulators: we need better alignment with regulatory issues
• Better data : better regulation
• Rapid data : more rapid regulation
• Celebrate achievements
• Apologies UK leaving EU
• Scotland voted to stay in EU but….. Farewell!15
Classified as internal/staff & contractors by the European Medicines Agency
• Further information:
www.encepp.eu
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Thank you for your attention!
http://www.encepp.eu/mailto:[email protected]
Report from the ENCePP Steering Group, 2017-2020Key pointsComposition of the ENCePP Steering Group 2017-2020SG meetings in the last four yearsSome of the key topics of the SG meetingsEU PAS Register – StatisticsENCePP Resource Database�EU PAS Register – Upgrade in January 2020ENCePP documents publishedENCePP Guide on Methodological Standards in Pharmacoepidemiology – website statisticsPublicationsPublicationsPublicationsCovid-related activitiesUpdate from Working Groups and Special Interest GroupsConclusions & Last WordsSlide Number 17
