25 November 2016 EMA/512056/2016

Inspections, Human Medicines Pharmacovigilance and Committees

Workshop: measuring the impact of pharmacovigilance activities Final programme 5 - 6 December 2016 European Medicines Agency, London, United Kingdom

30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 E-mail [email protected] Website www.ema.europa.eu

An agency of the European Union

© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

Introduction EU pharmacovigilance systems have been established to fulfil the tasks and responsibilities of EU pharmacovigilance legislation, to monitor the safety of authorised medicinal products and to detect and manage any change to their risk-benefit balance. Pharmaceutical companies and regulators have access to a variety of post-marketing surveillance tools that allow for systematic monitoring of the benefits and risks of medicinal products throughout the life-cycle. Pharmacovigilance activities include risk management planning and the detection, assessment, evaluation and management of drug-related adverse effects. They are designed to prevent harm caused by medicines and to enable their safe and effective use. In January 2016 the Pharmacovigilance Risk Assessment Committee (PRAC) adopted a strategy 1 for measuring the impact of pharmacovigilance activities which relies on a collaborative approach between stakeholders. Measuring the impact of key pharmacovigilance activities will allow those responsible for pharmacovigilance to determine which activities are most successful and to identify enablers and barriers for generating positive health impacts. Together, these will contribute to the further development of proactive pharmacovigilance systems and to promote best practice across the EU. The aim of this workshop is to facilitate the implementation of the PRAC strategy with a particular focus on the development of methodologies and on stakeholder collaboration.

1 Pharmacovigilance Risk Assessment Committee. PRAC strategy on measuring the impact of Pharmacovigilance activities (EMA/790863/2015).

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Welcome to participants Dear colleagues, On behalf of the European Medicines Agency I am pleased to welcome you to this international workshop on measuring the impact of pharmacovigilance activities. Pharmacovigilance systems have been established to monitor the safety of authorised medicinal products and to detect and manage any change to their risk-benefit balance. The EU has the most advanced pharmacovigilance systems in the world and we share a responsibility to ensure that key pharmacovigilance activities and processes are effective and efficient. We also share a responsibility to continuously improve. In January 2016 PRAC adopted a strategy for measuring the impact of pharmacovigilance activities. This relies on the collaboration between stakeholders to assess whether pharmacovigilance systems are fully achieving their public health objectives, and to identify areas for improvement. We are committed to working with all our stakeholders to deliver on this strategy. This workshop is an excellent opportunity to bring together the available expertise from partners and stakeholders, including regulatory and public bodies, healthcare-professional and patient-consumer organisations, academia, learned societies and the pharmaceutical industry. The workshop's objective is to develop methods in impact research and to identify enablers and barriers to measuring the impact of pharmacovigilance. Particular focus will be on new methods for measuring the impact of product-specific pharmacovigilance activities on clinical practice and health outcomes, as well as the impact of individual pharmacovigilance processes. We believe that a focused dialogue between regulators and stakeholders is crucial to foster collaboration and to engage the scientific community in efforts to measure the impact of pharmacovigilance activities. Only by measuring the impact of what we do can we ensure we are effective and continuously get better. Working together I am certain we can develop better methods for measuring pharmacovigilance impact and therefore better contribute to promoting and protecting public health. I look forward to meeting you in London!

Guido Rasi Executive Director

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Scope This workshop will be of interest to all stakeholders involved in pharmacovigilance activities and the public health impact of pharmacovigilance systems: health authorities; healthcare professionals; patient associations; regulators; pharmaceutical industry; academics; civil-society organisations; corporate decision-makers.

Sessions Session 1 Importance of measuring the impact of pharmacovigilance. Session 2 Approaches for measuring impact of pharmacovigilance and regulatory decisions. Session 3 Parallel breakout sessions: 3.1 Enablers and barriers to measuring impact – patient and healthcare professional engagement. 3.2 From regulatory outputs to health outcomes. 3.3 Measures of impact of pharmacovigilance processes. Session 4 Reports from breakout sessions: gaps and observations. Session 5 Way forward and next steps.

Outputs A synopsis of the workshop will be made publicly available. In addition, the workshop will support the delivery of recommendations on methodologies for measuring the impact of pharmacovigilance activities in line with the PRAC strategy.

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Programme Committee June Raine

Medicines and Healthcare products Regulatory Agency, United Kingdom

Tomas Salmonson

Medical Products Agency, Sweden

Peter Bachmann

Federal Institute for Drugs and Medical Devices, Germany

Dirk Mentzer

Paul-Ehrlich-Institute, Germany

Marieke De Bruin

University of Copenhagen, Denmark

Almath Spooner

Health Products Regulatory Authority, Ireland

Dolores Montero

Spanish Agency of Medicines and Medical Devices, Spain

Agnes Kant

Netherlands Pharmacovigilance Centre Lareb, Netherlands

Isabelle Moulon

European Medicines Agency

Michael Berntgen

European Medicines Agency

Xavier Kurz

European Medicines Agency

Peter Arlett

European Medicines Agency

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Programme details Monday, 5 December 2016 – Room 3A 12.00

Registration Welcome and opening

13.00

Opening remarks Guido Rasi European Medicines Agency

13.10

Introduction and objectives of the workshop Xavier Kurz (conference chair) European Medicines Agency

Session 1: Importance of measuring the impact of pharmacovigilance Session co-chairs: Almath Spooner and Marco Greco 13.20

Why measuring the impact of regulatory actions? June Raine Medicines and Healthcare products Regulatory Agency, United Kingdom

14.00

Regulatory initiatives for measuring the impact of pharmacovigilance Dolores Montero Spanish Agency of Medicines and Medical Devices, Spain

14.20

The PRAC strategy for measuring impact of pharmacovigilance activities Thomas Goedecke European Medicines Agency

14.40

Panel discussion

15.00

Coffee break Session 2: Approaches for measuring impact of pharmacovigilance and regulatory decisions Session co-chairs: Agnes Kant and Julie Williams

15.20

FDA experience with measuring the impact of pharmacovigilance Gerald Dal Pan Food and Drug Administration, United States

15.40

PMDA experience with measuring the impact of pharmacovigilance Shinobu Uzu Pharmaceuticals and Medical Devices Agency, Japan

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16.00

Health Canada experience with measuring the impact of pharmacovigilance John Patrick Stewart Health Canada, Canada

16.20

How is industry approaching the impact of pharmacovigilance activities? Robert Reynolds Pfizer Inc., United States

16.40

Challenges and opportunities to measuring the impact of regulatory actions Sabine Straus Medicines Evaluation Board, Netherlands

17.00

Panel discussion

17.20

End of day 1

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Tuesday, 6 December 2016 – Room 2D, 2E, 3A Session 3: Parallel breakout session – Brainstorming & Discussion For Session 3 discussion topics please refer to the Annex (page 13) 9.00

3.1 Enablers and barriers to measuring impact – patient and healthcare professional engagement (Room 2D) Martin Huber (chair) Federal Institute for Drugs and Medical Devices, Germany Patrick Brown (co-chair) University of Amsterdam, Netherlands

9.00

3.2 From regulatory outputs to health outcomes (Room 2E) Margarida Guimarães (chair) National Authority of Medicines and Health Products, Portugal Saad Shakir (co-chair) Drug Safety Research Unit, United Kingdom

9.00

3.3 Measures of impact of pharmacovigilance processes (Room 3A) Marieke De Bruin (chair) University of Copenhagen, Denmark Agnes Kant (co-chair) Netherlands Pharmacovigilance Centre Lareb, Netherlands

10.30

Coffee break

10.50

Session 3: Parallel breakout session – Wrap-up Parallel breakout sessions 3.1, 3.2 and 3.3 continue with discussions and preparation of break-out session reports in rooms 2D, 2E and 3A.

12.00

Lunch break Session 4: Reports from breakout sessions: gaps and observations Session co-chairs: Dolores Montero and Nawab Qizilbash

13.00

Report on ‘Enablers and barriers to measuring impact – patient and healthcare professional engagement’ Martin Huber Federal Institute for Drugs and Medical Devices, Germany Thomas Goedecke European Medicines Agency

13.20

Report on ‘From regulatory outputs to health outcomes’ Margarida Guimarães National Authority of Medicines and Health Products, Portugal Daniel Morales European Medicines Agency

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13.40

Report on ‘Measures of impact of pharmacovigilance processes’ Marieke De Bruin University of Copenhagen, Denmark Xavier Kurz European Medicines Agency

14.00

Panel discussion

14.30

Coffee break Session 5: Way forward and next steps Session co-chairs: June Raine and Marieke De Bruin

14.50

How can researchers contribute to measuring impact? Agnes Kant Netherlands Pharmacovigilance Centre Lareb, Netherlands

15.10

How can patients and caregivers contribute to generate data on behavioural changes? Elisa Ferrer European Organisation for Rare Diseases (EURORDIS), France

15.30

How can healthcare professionals contribute to generate data on behavioural changes? Jamie Wilkinson Pharmaceutical Group of the European Union, Belgium

15.50

How can pharmaceutical industry contribute to measuring impact? Vicki Edwards AbbVie Ltd., United Kingdom, on behalf of European Federation of Pharmaceutical Industries and Associations (EFPIA)

16.10

Pharmacovigilance system impact – EU regulatory network collaboration and initiatives Julie Williams Medicines and Healthcare products Regulatory Agency, United Kingdom

16.30

Panel discussion

Closing remarks 16.50

Closing remarks and next steps Xavier Kurz European Medicines Agency

17.00

End of conference

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List of speakers, chairs and panellists Marin Banovac

European Medicines Agency

Patrick Brown

University of Amsterdam, Netherlands

Gerald Dal Pan

Food and Drug Administration, United States

Marieke De Bruin

University of Copenhagen, Denmark

Vicki Edwards

AbbVie Ltd., United Kingdom

Stephen Evans

London School of Hygiene and Tropical Medicine, United Kingdom

Elisa Ferrer

European Organisation for Rare Diseases (EURORDIS), France

Thomas Goedecke

European Medicines Agency

Amie Goulbourne

Biogen, United Kingdom

Marco Greco

European Patients’ Forum, Belgium

Margarida Guimarães

National Authority of Medicines and Health Products, Portugal

Martin Huber

Federal Institute for Drugs and Medical Devices, Germany

Agnes Kant

Netherlands Pharmacovigilance Centre Lareb, Netherlands

Xavier Kurz

European Medicines Agency

Terri Madison

Mapi Group, United States

Dolores Montero

Spanish Agency of Medicines and Medical Devices, Spain

Daniel Morales

European Medicines Agency

Nawab Qizilbash

Oxon Epidemiology, United Kingdom

Guido Rasi

European Medicines Agency

June Raine

Medicines and Healthcare Products Regulatory Agency, United Kingdom

Robert Reynolds

Pfizer Inc., United States

Judith Sanabria

Biomedical Research Institute, University Hospital of Malaga, Spain

Rachel Sobel

Pfizer Inc., United States

Saad Shakir

Drug Safety Research Unit, United Kingdom

Almath Spooner

Health Products Regulatory Authority, Ireland

John Patrick Stewart

Health Canada, Canada

Sabine Straus

Medicines Evaluation Board, Netherlands

Maia Uusküla

State Agency of Medicines, Estonia

Shinobu Uzu

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Eric van Ganse

Red Cross Hospital Lyon Cedex, France

Jamie Wilkinson

Pharmaceutical Group of the European Union (PGEU), Belgium

Julie Williams

Medicines and Healthcare products Regulatory Agency, United Kingdom

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Practical information Venue The European Medicines Agency can be reached: •

By Docklands Light Railway (DLR) The European Medicines Agency is a short walk from Canary Wharf station on the DLR. Services run from Bank, Tower Gateway, Lewisham, Stratford, King George V and Beckton.



By Underground The nearest stop for the European Medicines Agency is Canary Wharf station on the Jubilee Line.



By bus Canary Wharf is serviced by local bus numbers D3, D7, D8, 135 and 277.



By boat River services run between Embankment, London Bridge and Canary Wharf throughout the day.



From London City Airport The European Medicines Agency is a 10-minute walk from Blackwall or Poplar station on the DLR. Alternatively, change at Canning Town to the Jubilee Line to Canary Wharf station.

Getting to the Agency A map showing travel connections to the Agency can be found here.

Entering the building The Agency operates a stringent security policy. Upon arrival at the ground-floor reception, you will be given a security pass that will allow you to make your way to meeting room 3A on the 3rd floor. Please show your ID or a credit card in your name. Tea and coffee will be available on your arrival in the 3rd floor foyer.

Physical disability Let us know if you would like any specific help or information that would make your stay more comfortable. We will be very happy to help.

Registration We would advise you to arrive up to one hour before the start of the workshop (i.e. at 12:00) to allow sufficient time for registration and settling down. Registration will take place in the foyer on the 3rd floor.

Meeting room This workshop will benefit from a full house and a seating plan with your name will be available for room 3A. For the parallel breakout session 3 on 6th December you will be assisted by EMA staff and a list with your name and parallel breakout session will be available.

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Presentations We will not circulate printouts of speakers' presentations. However, you will be able to download the presentations from the Agency's website approximately two weeks after the end of the workshop.

Catering The Agency has a restaurant and a deli bar that offer a variety of food and drinks during the day. They both operate a cashless payment system. No cash or credit/debit cards are accepted. You will be able to purchase a visitor card at the registration desk. In addition, visitor card terminals are available in the 4th floor restaurant. At the end of your visit, simply reinsert the card in one of the visitor card terminals and the deposit plus any account balance will be refunded. If visiting the Agency frequently, visitors may wish to retain the card for future use. Please note that the machine refunds in GBP coins only. For this reason, we encourage you to retain the card for future use or not to load it with more than £20. Please note the industry representatives do not have access to the EMA restaurant.

Media disclaimer The Agency records or broadcasts a number of its meetings, including some virtual meetings. This is part of the Agency's commitment to the principle of transparency as enshrined in the Treaty on European Union. The Agency herewith informs attendees that this particular meeting will be live broadcast and recorded. By attending this meeting you consent to any broadcast and recording.

Conference venue and secretariat European Medicines Agency 30 Churchill Place, Canary Wharf London E14 5EU, United Kingdom Telephone +44 (0)20 3660 6000 E-mail [email protected] Website www.ema.europa.eu

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Annex – Parallel session 3 topic list Tuesday, 6 December 2016, 9.00 – 12.00 Session 3.1

Enablers and barriers to measuring impact – patient and healthcare professional engagement (Room 2D) Session co-chairs: Martin Huber and Patrick Brown

09.00

Defining engagement – awareness and perception of public health measures Patrick Brown University of Amsterdam, Netherlands

09.20

ISPE paper “Evaluating the Effectiveness of Additional Risk Minimisation Measures via Surveys in Europe: Challenges and Recommendations” Rachel Sobel Pfizer Inc., United States Terri Madison Mapi Group, United States

09.40

Patient reporting in EudraVigilance – a measure of patient engagement? Marin Banovac European Medicines Agency, EU

10.00

Discussion and recommendations (continued after coffee break) All participants

Session 3.2

From regulatory outputs to health outcomes (Room 2E) Session co-chairs: Margarida Guimarães and Saad Shakir

09.00

Methods to go from process outcomes to health outcomes (e.g. use of surrogate measures and interrupted time series) Stephen Evans London School of Hygiene and Tropical Medicine, United Kingdom

09.20

Study of liver function monitoring in patients receiving agomelatine in the Estonian Health Insurance (EHI) database Maia Uusküla State Agency of Medicines, Estonia

09.40

Modelling methods to estimate the public health impact of regulatory decisions Saad Shakir Drug Safety Research Unit, United Kingdom

10.00

Discussion and recommendations (continued after coffee break) All participants

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Session 3.3

Measures of impact of pharmacovigilance processes (Room 3A) Session co-chairs: Marieke De Bruin and Agnes Kant

09.00

Challenges of measuring impact of new pharmacovigilance processes Judith Sanabria Biomedical Research Institute, University Hospital of Malaga, Spain

09.20

Measuring impact: a review of survey studies to evaluate the effectiveness of additional risk minimisation measures in Europe Nawab Qizilbash Oxon Epidemiology, United Kingdom

09.40

Measuring time from identification of a new risk to regulatory action with focus on signalling tools and processes Amie Goulbourne Biogen, United Kingdom

10.00

The risks of asthma therapy as assessed from real-life data: ASTRO-LAB & SNIIRAM Eric van Ganse Red Cross Hospital Lyon Cedex, France

10.20

Discussion and recommendations (continued after coffee break) All participants

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Workshop on measuring the impact of pharmacovigilance activities

Nov 25, 2016 - Page 3/14. Welcome to participants ... advanced pharmacovigilance systems in the world and we share a responsibility to ensure that key.

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