Inspections, Human Medicines Pharmacovigilance and Committees

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The European Medicines Agency's Inspections, Human Medicines Pharmacovigilance and Committees Division is responsible for pharmacovigilance, including signal detection and management and monitoring of products on the market, and provides leadership for the Agency’s pharmacovigilance system.

It ensures the coordination of inspections and good-practice standards. It deals with incident management in the area of safety and quality of human medicines, in liaison with the European medicines regulatory network. The Division maintains close contact with international partners in the areas of inspection and pharmacovigilance in conjunction with the Agency’s international-affairs function.

It provides organisation support for the operation of the Agency's scientific committees

An organisation chart shows the full structure of the Inspections, Human Medicines Pharmacovigilance and Committees Division.

Table of contents


Head of Inspections, Human Medicines Pharmacovigilance and Committees

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Head of Inspections, Human Medicines Pharmacovigilance and Committees

Fergus SweeneyFergus Sweeney

Nationality: Irish

Career to date:

  • Head of Inspections, Human Medicines Pharmacovigilance and Committees, European Medicines Agency (2016-present)
  • Head of Inspections and Human Medicines Pharmacovigilance, European Medicines Agency (2013-2016)
  • Head of Compliance and Inspections, European Medicines Agency (2009-2013)
  • Scientific Administrator, European Medicines Agency (1999-2009)
  • Director of Quality Assurance, Covance, Brussels, Belgium (1991-1999)
  • Manager of Quality Assurance, Institute of Clinical Pharmacology, Dublin, Ireland (1990)
  • Deputy Manager and Director of Quality Assurance, Institute of Clinical Pharmacology, Dublin, Ireland (1986-1990)
  • Laboratory Researcher, Institute of Clinical Pharmacology, Dublin, Ireland (1982-1986)

Education:

  • Doctor of Philosophy in Pharmacology, University College Dublin, Ireland (1986)
  • Doctorat de Troisième Cycle in endocrinology and development (cancer biology), University of Paris XI Orsay Centre, France (1982)
  • Bachelor of Arts in natural sciences (physiology), Trinity College Dublin, Ireland (1979)

Declaration of interests

Committees and Inspections

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Head of Committees and Inspections

Anabela Luis de Lima MarcalAnabela Luis De Lima Marçal

Nationality: Portuguese

Career to date:

  • Head of Committees and Inspections, European Medicines Agency (2016-present)
  • Head of Compliance and Inspections, European Medicines Agency (2013-2016)
  • Head of Community Procedures, European Medicines Agency (2009-2013)
  • Specialised Group Leader for Post-Authorisation Safety and Efficacy Central Nervous System / Endocrinology, European Medicines Agency (2001-2009)
  • Scientific Administrator, European Medicines Agency (1999-2001)
  • Scientific Administrator, Infarmed, Lisbon, Portugal (1995-1999)
  • Hospital Pharmacist, Dona Estefânia Hospital, Lisbon, Portugal (1991-1995)
  • Pharmacist, Community Pharmacy, Lisbon, Portugal (1991)

Education:

  • Professional certification in hospital pharmacy, Portugal (1994)
  • Degree in pharmacy, Portugal (1991)

Declaration of interests

Head of Scientific Committees Secretariat

Thorsten Olski

Nationality: German

Career to date:

  • Head of Scientific Committees Secretariat, European Medicines Agency (2017-present)
  • Scientific Administrator, European Medicines Agency (2008-2017)
  • Dermatology resident, University Medical Centre Cologne, Germany (2004-2008)

Education:

Declaration of interests (to be published)

Head of Manufacturing and Quality Compliance

Brendan CuddyBrendan Cuddy

Nationality: Irish

Career to date:

  • Head of Manufacturing and Quality Compliance, European Medicines Agency (2014-present)
  • Principal Scientific Administrator, European Medicines Agency (2010-2014)
  • Scientific Administrator, European Medicines Agency (2002-2010)

  • Compliance Specialist, Elan Pharma Ltd., Ireland (1997 - 2002)
  • Analytical Chemist, Malinckrodt Veterinary, Ireland (1993 – 1997)

Education:

Declaration of interests

Head of Clinical and Non-clinical Compliance

Ana Rodriguez Sanchez-BeatoAna Rodriguez Sanchez Beato

Nationality: Spanish

Career to date:

  • Head of Clinical and Non-clinical Compliance, European Medicines Agency (2009-present)
  • Scientific Administrator, European Medicines Agency (2003-2009)
  • Senior Clinical Research Associate, Covance, Madrid, Spain (2000-2003)
  • Clinical Research Associate, Pfizer, Madrid, Spain (1997-2000)
  • Post-doctoral Basic Researcher, Spanish National Research Council, Madrid, Spain (1995-1997)
  • Pre-doctoral Basic Researcher, Spanish National Research Council, Madrid, Spain (1991-1995)

Education:

Declaration of interests

Head of Parallel Distribution and Certificates

To be decided

Pharmacovigilance and Epidemiology

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Head of Pharmacovigilance and Epidemiology

Peter Arlett

Nationality: British

Career to date:

Education:

Declaration of interests

Head of Signal and Incident Management

Georgy GenovGeorgy Genov

Nationality: Bulgarian

Career to date:

  • Head of Signal and Incident Management, European Medicines Agency (2016-present)
  • Head of Signal Management, European Medicines Agency (2013-2016)
  • Head of Signal Detection and Data Analysis, European Medicines Agency (2012-2013)
  • Head of Signal Detection and Data Analysis (ad interim), European Medicines Agency (2011-2012)
  • Scientific Administrator, European Medicines Agency (2010-2011)
  • Associate Director Global Medical Affairs Immunology, UCB Pharma S.A., Brussels, Belgium (2006-2010)
  • Project Manager, Cardiovascular, Johnson & Johnson Medical, Waterloo, Belgium (2002-2005)
  • Medical Reviewer, Quintiles / Janssen Pharmaceutica N.V., Beerse, Belgium (2000-2002)
  • Clinical Research Associate, Quintiles, Sofia, Bulgaria (1998-2000)
  • Physician, Military Service, Bulgaria (1997-1998)

Education:

Declaration of interests

Head of Surveillance and Epidemiology

Xavier KurzXavier Kurz

Nationality: Belgian

Career to date:

  • Head of Surveillance and Epidemiology, European Medicines Agency (2016-present)
  • Head of Monitoring and Incident Management, European Medicines Agency (2014-2016)
  • Head of Monitoring and Incident Management (ad interim), European Medicines Agency (2013-2014)
  • Principal Scientific Administrator, European Medicines Agency (2005-2013)
  • Scientific Expert, Post-marketing and Pharmacovigilance, Belgian Centre for Pharmacovigilance, Ministry of Public Health, Brussels, Belgium (1994-2005)
  • Research Assistant and Adjunct Professor in Pharmacoepidemiology and Pharmacoeconomics, Department of Pharmacology, University of Liege, Belgium (1994-2000)
  • Research Fellow, Centre for Clinical Epidemiology and Community Studies, McGill University, Montreal, Canada (1993-1994)
  • Research Assistant, Scientific Institute of Public Health and Epidemiology, Brussels, Belgium (1992-1993)
  • Research Assistant (coordinator of projects in Mali, India and Bangladesh), Centre for Research on the Epidemiology of Disasters, Department of Epidemiology, School of Public Health, Catholic University of Louvain, Belgium (1987-1989)
  • Coordinator of tuberculosis and leprosy control programmes, Damian Foundation, South-Equateur Province, Congo (1983-1986)

Education:

Declaration of interests

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