update icsr reporting · simplified reporting of side effect reports for mahs with re-routing to...
Post on 29-Sep-2020
0 Views
Preview:
TRANSCRIPT
Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH www.ages.at
Update ICSR Reporting
Dr. Olga Rögelsperger
Austrian Federal Office for Safety in Healthcare
Institute of Surveillance
Dep. BTVI (Blood, Tissue & Vigilance)
Traisengasse 5, 1020 Vienna
www.ages.at
2
Disclaimer:
The views expressed in this presentation are personal ones and may
not be understood or quoted as being made on behalf of or reflecting
the position of the Austrian Competent Authority or European
Medicines Agency.
This presentation mainly builds on materials published by the European
Medicines Agency.
Dr. Olga Rögelsperger, 15.09.2016
www.ages.at ICSRs, Signaldetektion 3
Austrian Agency for Health and Food Safety
Wolfgang Hermann
Austrian Medicines and Medical Devices Agency (MEA)
Christa Wirthumer-Hoche
Business Development (GFEV)
Arnold Herzog
Bureau of the Austrian Federal Office for Safety in Health Care (BBSG)
Thomas Reichhart
Institute Marketing Authorisation of Medicinal
Products & Lifecycle Management (LCM)
Peter Platzer
Institute Assessment & Analytics (BGA)
Gerhard Beck
Institute Surveillance (INS)
Ronald Bauer
Regulatory Affairs (REGA)
Alexander Ertl
Medical Assessment (MRAT)
Ingeborg Gerngroß
Quality Assessment Medicinal Products (QUAL)
Susanne Stotter
Analytics of Biological Medicinal Products (BAMA)
Heidemarie Schindl
Analytics of Chemical-pharmaceutical Medicinal Products (CPAA)
Roman Macas
Clinical Assessment of Safety & Efficacy (CASE)
Barbara Tucek
Biologicals, Preclinical & Statistical Assessment & Centralised Procedures
of Veterinary Medicinal Products (BPSV)
Barbara Zemann
Good Manufacturing Practice (GMDP)
Andreas Kraßnigg
Clinical Trials (CLTR)
Ilona Reischl
Medical Devices Market Surveillance (MDVI)
Reinhard Berger
Blood, Tissue & Vigilance (BTVI)
Verena Plattner
AUSTRIAN FEDERAL OFFICE FOR SAFETY
IN HEALTH CARE
Quality Management (QMGT)
Klaus Stüwe
Scientific Office (SCIO)
Andrea Laslop
Assessment Pharmacovigilance (APHV)
Barbara Tucek
Herbal , Homeopathic & Veterinary Medicinal Products (HEVE)
Reinhard Länger
FG-Leiterin: Katharina Weber
www.ages.at
4
EudraVigilance: Direct EV Reporting MAH -> EMA
Dr. Olga Rögelsperger, 15.09.2016
www.ages.at
Legal Background (1/3)
5
Regulation (EC) 726/2004 requires the Agency to set up and maintain a PHV
database and data processing network (‘EudraVigilance (EV) database’) in
support of the following:
“Auditable requirements” as endorsed by the EMA Management Board in
December 2013:
Simplified reporting of side effect reports for MAHs with re-routing
to NCAs;
Provision of reports to WHO (respecting EU data protection legislation);
Security (authentication, authorisation and data transaction to limit the
risks of unauthorised access).
Dr. Olga Rögelsperger, 15.09.2016
www.ages.at
Legal Background (2/3)
6
EV access for MAHs to conduct product monitoring including signal
detection (respecting EU data protection legislation);
Publication of data and search availability for healthcare
professionals and the public for all medicines authorised in the EU;
Compliance with international ICSR standards (and compatibility with
IDMP standards based on Article 57 data) by 1 July 2016 including
backwards and forwards conversion tools for E2B(R2)/(R3) messages;
Conversion of legacy data (> 7 mill. ICSRs currently held in EV);
Dr. Olga Rögelsperger, 15.09.2016
www.ages.at
Legal Background (3/3)
7
System performance and scalability based on increased number of users and volume of data;
Before the move to centralised reporting and the new data structure for ICSRs, the new EudraVigilance system has to undergo an independent audit that will check that the required functionalities agreed with the Pharmacovigilance Risk Assessment Committee (PRAC) and the EMA Management Board in December 2013 have been implemented.
The audit report along with a PRAC recommendation will be presented to the EMA Management Board, which will then announce if the EudraVigilance system has implemented the functionalities.
Six months after the announcement of the EMA Management Board, the move to centralised reporting will take effect.
Dr. Olga Rögelsperger, 15.09.2016
www.ages.at
Project Timeline Changes
8
The proposed new timeline consists of:
2
3
4
Change of the EV Audit to February 2017 (original date August
2016);
Change the decision by EMA Management Board on simplified reporting to May
2017 via written procedure (original date December 2016)*;
Change the go-live date delayed to mid-November 2017 (original date Q3 2017).
While the audit will move by 6-months, the go live to simplified reporting will only move by 4-months (to November 2017) due to efficiency gains in
the post audit part of the project plan.
1 Change of the EV Stakeholder testing to November 2016 (original
date June 2016);
*Note: the key audit result will be presented to March 2017 EMA Management Board.
Dr. Olga Rögelsperger, 15.09.2016
www.ages.at
Useful links
• EMA Management Board minutes http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/06/news_detail_002552.jsp&mid=WC0b01ac058004d5c1
• Eudravigilance Communication plans http://www.ema.europa.eu/docs/en_GB/document_library/Other/2015/10/WC500196040.pdf
• New Eudravigilance pages http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000679.jsp&mid=WC0b01ac05800250b5
Here also publication of new EudraVigilance training materials; PhV-M0 Introduction to EMA’s training offerings’ for additional information on the
recommended learning paths for each stakeholder group
9 Dr. Olga Rögelsperger, 15.09.2016
www.ages.at
10
Encouraging HCPs to report suspected adverse drug reactions
Dr. Olga Rögelsperger, 15.09.2016
www.ages.at
Stakeholder Engagement
Projekt „Bewerbung NW-Meldungen“ bestehend aus
• 3 Fachartikel:
Medical Tribune, Nr. 19, 11. Mai 2016,
Pharmaceutical Tribune,
Up-to-date
• AGES–Patientengespräch „Woher bekomme ich welche Info?“ - in Kooperation mit der European Patients‘ Academy on Therapeutic Innovation (EUPATI), 9.6.2015, AGES Spargelfeld
• AGES-Gespräch für HCPs, 13.10.2016, AKH Wien
11 Dr. Olga Rögelsperger, 15.09.2016
www.ages.at
12
Medical Literature Monitoring (MLM)
Dr. Olga Rögelsperger, 15.09.2016
www.ages.at
MLM What not to do
• NCAs in EEA Member States should not forward/provide the ICSRs resulting from the MLM service to the concerned MAHs, since MAHs can download those ICSRs from the EudraVigilance Download Area.
• Concerned MAHs should not re-submit the ICSRs resulting from the MLM service to EudraVigilance.
• Unless otherwise specified by national legislation and guidance, concerned MAHs should not submit ICSRs resulting from the medical literature monitoring service to the concerned NCA in the EEA.
13 Dr. Olga Rögelsperger, 15.09.2016
www.ages.at
Questions?
http://www.basg.gv.at/ pharm-vigilanz@ages.at lob_und_tadel@ages.at
14 Dr. Olga Rögelsperger, 15.09.2016
top related