EMA EudraVigilance Information Day Event #17592 15 December 2017 European Medicines Agency, London, United Kingdom

OVERVIEW

FACULTY Gaby Danan, Pharmacovigilance expert, France Francois Domergue, EV Auditable Requirement Project Manager, Business Data and Analytics Department, EMA, EU Françoise Dumas-Sillan, EU QPPV, Pfizer, IT Johan Ellenius, Team Manager, Researcher, Uppsala Monitiring Center (UMC), SE Augusto Filipe, Medical Director, Tecnimede, PT Nick Halsey, Scientific Administrator, Data Collection and Management, EMA, EU Linda Harmark, Netherlands Pharmacovigilance Centre Lareb (Lareb), The Netherlands David J Lewis, Global Head of Pharmacovigilance, Novartis Pharma AG, Switzerland Simon Maskell, Professor of Autonomous Systems, University of Liverpool, United Kingdom (UK) Subhash Mistry, Manager (Applications Development and Support), GSK, UK Victoria Newbould, Scientific Administrator, EMA, EU

The go-live of the new and enhanced EudraVigilance system is a major milestone based on the updated European Union (EU) pharmacovigilance legislation, which brought about significant changes to electronic reporting requirements for suspected adverse reactions to support better safety monitoring for medicines and a more efficient system for stakeholders. EMA published a first version of the EudraVigilance Change Management Plan in 2015 to assist national Competent Authorities, marketing authorisation holders and sponsors of clinical trials in preparing for the necessary IT changes and business processes. This EudraVigilance Information Day provides a forum to discuss the very initial experience of stakeholders with the new EudraVigilance system functionalities following its launch in November 2017, the use of the new ICH E2B(R3) standard, the simplified adverse reaction reporting and the data analysis outputs. The Information Day will also serve as a platform to experts to raise questions on the practical application of the recently revised GVP Modules VI and IX. In addition, a session is dedicated to summarise the results and achievements of the Innovative Medicines Initiative (IMI) WEB-RADR project, which looked at the development of a dedicated mobile app for patients and healthcare professionals to report suspected adverse reactions to national EU regulators and investigating the potential for publicly available social media data for identifying drug safety issues. KEY TOPICS • EudraVigilance auditable requirements project – first go live experience

Loris Piccolo, Scientific Administrator, EMA, EU

• The new simplified reporting rules and impact on stakeholders

Gerhard Reike, Bayer Healthcare Pharmaceuticals, DE EU

• Signal management using EVDAS

Rodrigo Postigo, Signal Management Lead, Pharmacovigilance Department, EMA, EU

• IMI WEB-RADR project – achievements and next steps

June Raine, Director – VRMM, Medicines and Healthcare products Regulatory Agency (MHRA), UK. PRAC Chair

TARGET AUDIENCE

Gilles Touraille, Pharmacovigilance and Risk Management, EMA, EU Phil Tregunno, Signal Management Unit Manager, MHRA, UK Margaret Walters, Director & Deputy EU Qualified Person for Pharmacovigilance, Merck, Sharp & Dohme Ltd (MSD), UK Sofia Zastavnik, Scientific Administrator, EMA, EU

• Frequently asked questions on the application of GVP Module VI and IX

• Qualified Persons Responsible for Pharmacovigilance (QPPVs) • Sponsors of clinical trials • Individuals involved in pharmacovigilance, safety database, signal management and, information management • IT system developers and data managers PROGRAMME COMMITTEE Paolo Alcini, Head of Data Standardisation and Analytics Service, European Medicines Agency (EMA), European Union (EU) Sabine Brosch, Principal Scientific Administrator, Pharmacovigilance and Epidemiology

DETAILS OF THE INFORMATION DAY Location: European Medicines Agency 30 Churchill Place Canary Wharf, London E14 5EU, United Kingdom Capacity: The event is limited to 110 participants

Department, EMA, EU Georgy Genov, Head of Signal and Incident Management Service, EMA, EU Anja van Haren, EudraVigilance Coordinator, Medicines Evaluation Board (MEB), The Netherlands

2

AGENDA

08:00 REGISTRATION 08:50 WELCOME NOTE Peter Arlett, Head of Pharmacovigilance and Epidemiology Department, EMA, EU 09:00

KEY NOTE

EudraVigilance and its impact on pharmacovigilance June Raine, MHRA, PRAC chair 09:30

SESSION 1

EUDRAVIGILANCE GO-LIVE Session chairs: Sabine Brosch, EMA, and Margaret Walters, MSD This session provides insight in the final preparations of the Agency for the go-live of the new and enhanced EudraVigilance system and outlines some of the next steps. The efforts in preparing for the changes, the go-live experience and lessons learned will be addressed from an industry perspective. The session concludes with a panel discussion allowing participants to raise specific implementation questions. The launch of the new EudraVigilance system: achievements and next steps Francois Domergue, EMA Go-live experience and lessons learned Subhash Mistry, GSK Q&A/Panel Discussion Paolo Alcini, EMA, Nick Halsey, EMA, Gaby Danan, Pharmacovigilance expert, David Lewis, Novartis 10:30 11:00

COFFEE BREAK SESSION 2

12:30 13:30

SANDWICH LUNCH SESSION 3

EUDRAVIGILANCE AND SIGNAL MANAGEMENT Session chairs: Georgy Genov, EMA, and Margaret Walters, MSD For the first time EVDAS and the signal management functionalities are made available to MAHs. Furthermore, GVP Module IX, revision 1 defines new responsibilities for MAHs, which need to be incorporated as part of the MAHs’ business processes and IT systems. This session will allow MAHs to share their experience and activities and provide the audience a platform to discuss lessons learned. EVDAS and signal management by marketing authorisation holders Françoise Dumas-Sillan, Pfizer Signal management process updates based on GVP Module IX Gerhard Reike, Bayer Q&A/Panel Discussion Rodrigo Postigo, EMA, Loris Piccolo, EMA Gaby Danan, Pharmacovigilance expert David Lewis, Novartis

14:45 15:15

COFFEE BREAK SESSION 4

PHARMACOVIGILANCE AND THE USE OF SOCIAL MEDIA AND NEW TECHNOLOGIES Session chairs: Sabine Brosch, EMA, and Phil Tregunno, MHRA Achievements of WEB-RADR and next steps David Lewis, Novartis

EUDRAVIGILANCE AND ADVERSE REACTION REPORTING Session chairs: Sabine Brosch, EMA, and Phil Tregunno, MHRA

Can pharmacovigilance benefit from social media analytics? Simon Maskell, University of Liverpool, and Johan Ellenius, UMC

Taking into account the significant changes to electronic reporting requirements for suspected adverse reactions to support better safety monitoring for medicines and a more efficient system for stakeholders the benefits and expectations from a regulator’s and industry perspective will be discussed. The panel discussion will further allow to raise questions related to GVP Module VI, of which revision 2 was published in September 2017.

Q&A/Panel Discussion Victoria Newbould, EMA, Margaret Walters, MSD, Gaby Danan, Pharmacovigilance expert 16:45

END OF INFORMATION DAY

Electronic submission of ICSRs and Article 57 data – how does it all fit together in EudraVigilance? Sofia Zastavnik, EMA, The new and simplified adverse reaction reporting requirements – a perspective from the MEB/LAREB Linda Harmark, Lareb The new and simplified adverse reaction reporting requirements – an industry perspective Margaret Walters, MSD Augusto Filipe, Tecnimede Q&A/Panel Discussion Gilles Touraille, EMA, Paolo Alcini, EMA, Francois Domergue, EMA, Gaby Danan, Pharmacovigilance expert, David Lewis, Novartis

Unless otherwise disclosed, DIA acknowledges that the statements made by speakers are their own opinion and not necessarily that of the organisation they represent, or that of the DIA. Speakers and agenda are subject to change without notice. Recording during DIA sessions is strictly prohibited without prior written consent from DIA.

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ID #17592

EudraVigilance Information Day 15 December 2017 | European Medicines Agency | London, United Kingdom SEND YOUR COMPLETED REGISTRATION FORM TO DIA CONTACT CENTRE TEAM, E-mail: [email protected] Fax: +41 61 225 51 52 For more information please call +41 61 225 51 51

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