Update ICSR Reporting · Simplified reporting of side effect reports for MAHs with re-routing to NCAs; Provision of reports to WHO (respecting EU data protection legislation); Security

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

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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

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EudraVigilance: Direct EV Reporting MAH -> EMA


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Legal Background (1/3)

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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).


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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);


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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.


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Project Timeline Changes

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The proposed new timeline consists of:

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3

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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.


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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

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/06/news_detail_002552.jsp&mid=WC0b01ac058004d5c1




http://www.ema.europa.eu/docs/en_GB/document_library/Other/2015/10/WC500196040.pdf



http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000679.jsp&mid=WC0b01ac05800250b5



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Encouraging HCPs to report suspected adverse drug reactions


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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


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Medical Literature Monitoring (MLM)


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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.


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Questions?

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Update ICSR Reporting · Simplified reporting of side effect reports for MAHs with re-routing to NCAs; Provision of reports to WHO (respecting EU data protection legislation); Security