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E ^ G I Z M G I W I Z M F P I M G M H I H S M Y a K G M S K i W R M � ] S W Z M G M i c S M Y a K G M W P L c Z W P W ^ G I Z K I ] S W P W I Z K R M K P c _ ^ G I Z M G F P I M G M H I H W G_ K Y I H I Z K I H Z W ^ a S i M L K S M j ^ i a F Y F P G M a K I F W P I W I Z M Y W P S ^ Y I W _ I Z M H I ^ S c ~b Z W ^ a S I Z M G M i M K P c Y Z K P V M W _ I Z M K i W R M S ^ M I W I Z M _ K Y I I Z K I ] K Y � ^ F G M K S S F I F W P K a F P I M G M H I H � ] H Z K a a j G W L j I a c P W I F _ c I Z Mn J [ M ` ` b M Y G M I K G F K I K P S Y W L j a M I M K P M k m M Y a K G K I F W P W _ ] P I M G M H I H S M I K F a F P V I Z M Y Z K P V M H ~] Y W P _ F G L I Z M F P _ W G L K I F W P S M Y a K G M S W P I Z F H _ W G L F H K Y Y ^ G K I M I W I Z M i M H I W _ L c g P W k a M S V M K P S ] Y W P H M P I I W L cF P _ W G L K I F W P i M F P V H I W G M S M a M Y I G W P F Y K a a c K P S j ^ i a F H Z M S W P I Z M n \ ` f b O M V F H I M G ~E \ Q Q J f ¼ n N O F K P P M R K P S M P T K Lb ] ½ J f d \ O n N4

Date: 04/11/2016

of 3 Version-number 1.5

Declaration of Interests for ENCePP SEAL Studies

INTRODUCTION

This document includes your personal details and your declaration of interests to be made public in line with the provisions of the ENCePP Code of Conduct. All parts must be duly completed. Your declaration will not be accepted if any fields are left empty. You are responsible for the accuracy and completeness of the submitted information. The form is designed to be filled in electronically and to be transmitted to the ENCePP Secretariat by email; in parallel, a copy of the form should be uploaded to the EU PAS Register.

SECTION 1: PERSONAL DETAILS

First Name: Luz M

Last Name: León-Muñoz

Organisation / Research Centre :

División de Farmacoepidemiología y Farmacovigilancia Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) Spanish Agency for Medicines and Medical Devices (AEMPS)

Country: Spain

Contact e-mail Address: [email protected]

Characterising the risk of major bleeding in patients with Non-Valvular Atrial Fibrillation: non-interventional study of patients taking Direct Oral Anticoagulants in the EU

Study Reference Number: EUPAS 1 6 0 1 4

Are you the (Primary) Lead Investigator of the above study? YesNo ✔

Are you an investigator/researcher contributing to the above study Yes ✔No


SECTION 2: DECLARATION OF INTERESTS RELATED TO PHARMACEUTICAL INDUSTRY

In this section you must declare any interests in the pharmaceutical industry that you currently have or had within the past 3 years. If you have interests to declare please tick 'Yes' to the relevant questions. All questions in this part must be answered.

2.1 Employment No ✔ Yes

Employment in a pharmaceutical company during past 3 years of study application? Pharmaceutical company includes supply or service companies which contribute to research, development, production and maintenance of a medicinal product. Employment relates to salaries currently being directly paid to you by a pharmaceutical company.

2.2 Financial Interest No ✔ Yes

Financial interests in the capital of a pharmaceutical company? Financial interests relate to current holding of shares of a pharmaceutical company with the exclusion of independently managed investment funds/pensions schemes that are not exclusively based on the pharmaceutical sector.

2.3 Patent No ✔ Yes

Patent for a medicinal product? Relates to a patent for a medicinal product currently owned by either you as individual or your organisation/ research centre, and you as individual are the beneficiary.

2.4 Consultancy No ✔ Yes

Consultancy for a pharmaceutical company during the past 3 years of study application? Consultancy refers to provision of advice or services to a pharmaceutical company excluding the concerned study and including but not limited to reviewing activities, data monitoring, statistical analysis, end point committees, regardless of contractual arrangements or any form of remuneration such as consulting fees or honoraria. Note that conference/seminar attendance is not considered a consultancy but should be indicated if subject to fee or honorarium.

2.5 Strategic Advisory Role No ✔ Yes

Strategic Advisory role on activities of a pharmaceutical company during the past 3 years of study application? Participation with the right to vote on/influence the output in a (scientific) advisory board/steering committee with the role of providing advice/expressing opinions on the future strategy, direction or development activities of a pharmaceutical company either in terms of general or product-related strategy, regardless of contractual arrangements or any form of remuneration.

2.6 Grant / Funding No ✔ Yes

Grant/funding from a pharmaceutical company other than funds contemplated in the concerned study contract? Refers to a grant or funding from a pharmaceutical company which is currently being received by your research group, irrespective of whether you are employed or a volunteer, and you receive no personal gain.

In this section you should declare any other interests to be made known to the public.

SECTION 3: ANY OTHER INTERESTS No ✔ Yes

Any other relationships/conditions/circumstances that present a potential conflict of interest, including matters relating to members of your family?

Further to the interests declared above, I do hereby declare on my honour that I do not have any further interests or facts that should be made public in relation to the conduct of the study. Should there be any change of the above due to the fact that I acquire additional interests, I shall promptly notify the ENCePP Secretariat and complete a new Declaration of Interests detailing the changes. I confirm the information declared on this form is accurate to the best of my knowledge and I consent to my information being stored electronically and published on the EU PAS Register.

FULL NAME: Luz M León-Muñoz

✔

Date: 19/01/2017


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