Speakers

Who’s who at Pharmacovigilance and Risk Management Strategies ?

,

• Dr. Monica Rusu, Director Pharmacovigilance EELA, Abbott Products GmbH
  
  • Pharmacist, Doctorate in Pharmacy
  • Entered in the pharma industry in 1995 as collaborator for an Indian generic company.
  • In 2000 started to be involved in Regulatory Affairs activities.
  • Joined Solvay Pharmaceuticals – local branch office Romania in 2002 as Regulatory Affairs & Drug Safety Manager.
  • Since 2007: Director Pharmacovigilance Eastern Europe & Latin America and Coordinator of Regional PV Management within Solvay Pharmaceuticals – Headquarters in Hannover, Germany
• Hans Joachim Gamperl, VP Global Drug Safety and Pharmacovigilance QPPV, Fresenius Biotech
  
  Dr. Hans-Joachim Gamperl, DVM, MDRA
  Born 07.01.1952
  
  Training/Education:
  Doctor of Veterinary Medicine
  Master of Drug Regulatory Affairs
  
  Professional Career:
  15 years international cooperation projects
  15 years in pharmaceutical industry (Transplantology, Oncology)
  
  • 11 years QPPV (German Stufenplanbeauftragter)
  • 6 years EU QPPV
  Current Position:
  Vice President Global Pharmacovigilance / Quality Management GCP
  EU and local QPPV
  Fresenius Biotech GmbH, Munich
• Ennis Lee, Vice President, QPPV Pharma, Johnson and Johnson
  
  Dr Ennis Lee is the EEA Qualified Person for Pharmacovigilance for Johnson and Johnson Pharma. Dr Lee trained as a physician in London at Westminster Medical School and, after a number of years in NHS practice, joined the pharmaceutical industry in the 1980s. She worked in a number of major pharmaceutical companies, latterly as Medical Director, before joining the Medicines Control Agency in 1995. Here Dr Lee became the Group Manager for Pharmacovigilance and the UK delegate to the Pharmacovigilance Working Party. Dr Lee joined Johnson and Johnson in 2001 in the area of early development of new medicinal products before joining the European regulatory group, and then becoming the QPPV for Pharma in May 2007.
• Philippe Van der Auwera, Global Head of Safety Risk Management and EU-QPPV, Roche
  
  Doctor Philippe Van der Auwera has received extensive academic training and has practical experience in clinical medicine, drug development, public health and risk management.
  
  He sits on the Drug Safety Committee and on the Development Leadership Team.
  
  His previous roles in the company include: Therapeutic Area Head/Group Leader of Infectious Diseases, Inflammation, Bone & Joint, Dermatology & Growth Factors in Clinical Development (7 years), Medical Affairs, Life Cycle Leadership (Boniva/Bonviva), Business Director Anemia Franchise (NeoRecormon/MIRCERA).
  
  He joined F. Hoffmann-La Roche Ltd in 1993 after a rich academic career at various institutions including the Tumour Center of the Free University Brussels, Jules Bordet Institute (Head of the Infectious Disease Clinic & Research Lab. as well as the Diagnostic Laboratories) , with numerous teaching assignments at the Free University Brussels, Liege State University, Mons State University, Tropical Institute of Antwerp and Superior Technical School of Charleroi. He has authored/co-authored 225 original papers , review articles and chapters in books as well as 213 abstracts of oral/poster communications to medical congresses. He has been the director of 50 theses (superior technical schools and universities).
  
  Background:
  MD: Free University Brussels, specialty in Laboratory Medicine & Nuclear Medicine in vitro; PhD: Free University Brussels
• Stephen Heaton, Head of Safety Risk Management Planning and Co-ordination, Global Pharmacovigilance, Bayer Schering Pharma
  
  Stephen Heaton was trained in pediatrics at Beth Israel Medical Center in New York, and in infectious diseases at the State University of New York at Downstate in Brooklyn. He practiced pediatric infectious diseases with a focus on pediatric HIV and AIDS at Beth Israel Medical Center for over a decade, and was an investigator with the Pediatric AIDS Clinical Trials Group (PACTG) sponsored by the NIH. He has been on faculty as assistant professor of pediatrics at the Mount Sinai School of Medicine and the Albert Einstein College of Medicine in New York. He entered the pharmaceutical industry and pharmacovigilance in 2001, and has headed operational and medical assessment groups within pharmacovigilance. His interest is focussed on pediatric drug safety and safety risk management. He is currently the Head of Safety Risk Management Planning and Coordination for Bayer Schering Pharma.
• Vicki Edwards, Senior Director, European Pharmacovigilance, Abbott
  
  
• Ute Hoeffner, EU Qualified Person for Pharmacovigilance, Novartis Consumer Health
  
  Dr. Ute Hoeffner M.D. with several years of training in basic pharmacological research at the Mayo Clinic, Rochester, MN followed by clinical training as Anaesthesiologist at the University Hospital, Munich. Experience as Scientific Advisor at the Bavarian Academy for Addiction Affairs in Research and Practice. Joining Pharmacovigilance within the Pharmaceutical Industry in January 2001, taking on increasing responsibilities in Drug Safety (Scientific Advisor, Associate Director Medical Safety assessment, Deputy Graduated Plan officer and EU-QPPV) With Novartis Consumer Health since August 2007, EU QPPV since Jan. 2008, located in Munich Germany, which is a special situation as the Novartis Headquarters are in Nyon, Switzerland and New York, USA.
• Peter De Veene, Deputy European Qualified Person for Pharmacovigilance, Roche
  
  Peter De Veene, Deputy EU Qualified Person for Pharmacovigilance
  
  Role: Deputy EU Qualified Person for Pharmacovigilance and head of the Office of the QPPV, managing an extended office with cross-functional representation to support the organisation in meeting the requirements as per Volume 9A.
  
  Background: I received my medical degree from the University of Leuven (Belgium) and spent some time in clinical practice in the UK. I joined Roche UK in 2004 in the local drug safety department. Following a move to Basel and supporting a major oncology product, I have currently been in this position since June 2008.
• Doris Stenver, Chief Medical Officer, Consumer Safety Division, Danish Medicines Agency
  
  Doris I. Stenver joined the Danish Medicines Agency in 1998. Her present position is Chief Medical Officer in the Consumer Safety Division. Throughout 11 years she has been the Danish delegate in the Pharmacovigilance Working Party.
  
  Doris I. Stenver graduated from Copenhagen University, the Faculty of Medicine, in 1986. During the following 12 years she worked at university hospitals in the Copenhagen area, and in 1995 she became specialist in internal medicine. Her clinical experience covers a wide range of medical specialties, e.g. nephrology, endocrinology, haematology, cardiology and infectious diseases. Her research activities were primarily within the areas of haematology, immunology, nephrology and endocrinology. After having joined the Danish Medicines Agency in 1998 and as member of the Pharmacovigilance Working Party she has been engaged in the following activities:
  
  
  • Assessment and evaluation of drug safety issues, including Risk Management Plans
  • Handling of safety issues in cooperation with the pharmaceutical industry, regulatory authorities, health care professionals and academia
  • Development of risk management strategies
  • Development of legislation, policies and guidelines in relation to pharmacovigilance
  • Scientific advice to pharmaceutical industry
  • Expert advice, seminars, workshops and training programmes for regulatory authorities in East- and Central Europe prior to enlargement
  • Communication to health care professionals and the public on drug safety concerns and recommendations
  
  
  Since 2002 she has been a member of the European Risk Management Strategy Facilitation Group. In 2007 she obtained a master degree in Public Administration from Copenhagen Business School. In recent years she has been engaged in the establishment of an international Pharmacovigilance Diploma education in cooperation with the Danish Association of Pharmaceutical Industry / Medicademy, both as member of the education steering committee, as course leader and speaker.
  
  Contact details : Address (office):
  Danish Medicines Agency
  1 Axel Heides Gade
  DK-2300 Copenhagen S
  DENMARK
  Phone +45 44 88 92 47
  Cell phone +45 22 46 09 79
  e-mail dis@dkma.dk
• Rannveig Gunnarsdóttir, Executive Director, Icelandic Medicines Control Agency
  
  Mrs. Rannveig Gunnarsdóttir Executive Director of the Icelandic Medicines Agency was previously the Pharmaceutical Officer at the Ministry of Health and Social Securities and subsequently director for the State Committee on Pharmaceuticals when the Committee was merged with the State Drug Inspectorate to form the Medicines Control Agency in 2000. Mrs. Gunnarsdottir graduated from the University of Iceland in pharmacy and holds a M.Sc.degree in Biopharmacy from London University. Prior to her public appointments she worked at the Hospital Pharmacy at the University Hospital in Iceland and as its director from 1990-1995. Mrs. Gunnarsdóttir has participated in many committees and has given numerous lectures during her professional life. She is has been a member of a committee establishing Pharmaceutical Policy for Iceland. She is an observer at the EMEA Management Board and a member of the Head of Regulatory Agencies Group. She was lecturer at the University of Iceland 1986-92, member of the Board of the Pharmacy Union 1985-1989, Deputy Chairman 1988 and Chairman 1989 and Chairman for the Committee for further Education for Pharmacists in1983-88. She is a founding member of Rotary Club Reykjavik Midborg since 1994. Mrs Gunnarsdottir is married with two children and two grandchildren.
• Enrica Alteri, Head Risk Management & Epidemiology, Global Drug Safety, Merck Serono
  
  Dr. Enrica Alteri received her Medical Doctorate from the University La Sapienza in Rome, Italy. Dr. Alteri completed a post-doctoral Fellowship in the Department of Immunopathology of the National Cancer Institute (USA). A Diploma in Pharmaceutical Medicine completed Enrica’s academic education.
  
  In 1986 Dr. Alteri joined Oncology/Infectious Diseases Research at Ciba and was involved in drug discovery projects on AIDS. Later, Dr. Alteri moved to the Safety & Epidemiology Department of Ciba (later to merge into Novartis) where she gained extensive Pharmacovigilance experience, as Safety Medical Expert responsible for products in various therapeutic areas. Among them is worth mentioning Coartem/Riamet, the current WHO first-line treatment against malaria, the safety profile of which was established by Enrica’s Team.
  
  Dr. Alteri has been Director of Pharmacovigilance at Serono from 2001 until 2007. Currently, Enrica is Head of the Risk Management & Epidemiology Group in Merck-Serono. The Group directed by Enrica is the global responsible for the managing the risk of all Merck-Serono’s marketed and investigational products.
  
  Dr. Alteri has been a member of the European Course of Pharmaceutical Medicine faculty (ECPM in Basel) and of the CIOMS Working Group on Pharmacovigilance in Resource-poor Countries.
• Ola Caster, Drug Safety Analyst, Uppsala Monitoring Centre
  
  Ola Caster works as Drug Safety Analyst at the research department of the Uppsala Monitoring Centre. He has a strong applied as well as methodological background in pharmacovigilance, with MSc degrees in pharmacy and mathematical statistics. His main research interests are quantitative methods to aid signal detection in pharmacovigilance, and quantitative approaches to risk-benefit assessments.
• David Turner, Patient Safety Scientist, AstraZeneca
  
  David John Turner – Patient Safety Scientist AstraZeneca (UK), experience with safety surveillance of drugs in most phases of life-cycle
  B.Sc.(Hons) Pharmacology - 1999
  Commenced work at AstraZeneca Clinical Data Management – 2000
  Transferred internally to AstraZeneca Patient Safety – 2001
  Commenced part-time post-graduate studies (Pharmacovigilance) at The University of Hertfordshire – 2005
  Commenced M.Sc. research project– 2007
  Submitted thesis – 2009
  Graduated M.Sc. – 2010
• Daniel O. Koralek, PhD, Associate Director, Epidemiology,Worldwide Safety Strategy, Pfizer
  
  Daniel Koralek is an associate director in Epidemiology in the Worldwide Safety Strategy division of Pfizer, Inc. He earned his PhD in Epidemiology at the University of North Carolina at Chapel Hill where he continued his collaborations with the National Cancer Institute for his doctoral dissertation. While completing his PhD, Daniel worked as a research assistant for GlaxoSmithKline (Musculoskeletal TA) in Research Triangle Park, NC. He has extensive experience in conducting observational studies in academic, government, and industry settings and currently leads a large observational safety study across more than 20 countries.
• Erica Velthuis, Senior Pharmacovigilance Scientist, Genzyme
  
  Erica Velthuis (PhD,MSc) is since March 2008 assigned as Sr. Pharmacovigilance Scientist at Genzyme Europe in the Netherlands and has a ten-year experience of pharmaco-epidemiology at N.V. Organon’s Drug Safety Surveillance Department. She has experience in providing epidemiological support for PSUR’s, Risk Management Plans, and questions from health authorities by writing literature reviews and position papers; in setting up an automated signal detection and evaluation program by using disproportionallity analyses; and in designing epidemiological studies. Before that she worked 2½ years at N.V. Organon’s Regulatory Affairs. Erica got her PhD at the TNO Food and Nutrition Institute in collaboration with the University of Maastricht at the faculty of Health Sciences, and did a Masters program on clinical epidemiology at the University of Rotterdam, the Netherlands.
• Petra Heyen, VP Regulatory Affairs and PV, Therabel Pharma
  
  
• Dr Brian Edwards, Scientific Advisor, Pharmacovigilance & Drug Safety, NDA Regulatory Science
  
  Until July 2007, Dr. Edwards was one of the deputy qualified persons for pharmacovigilance for Johnson & Johnson. Up until November 2005, he was Senior Director in PAREXEL International’s Scientific and Medical Services. His responsibilities included medical input into clinical trials and post-marketing pharmacovigilance He sat on the internal PAREXEL steering group overseeing the implementation of the European Clinical Trial Directive. Before joining PAREXEL, Dr. Edwards was a Senior Medical Assessor in the Pharmacovigilance Assessment Group, Medicines Control Agency (MCA), in the UK where he was responsible for the assessment of major drug/vaccine safety issues. Dr. Edwards holds a Doctor of Medicine degree from the University of London, Guy's Hospital Medical School. He is Treasurer and member of the Executive Committee for the International Society of Pharmacovigilance (ISoP) and Co-chair of the clinical safety and pharmacovigilance SIAC for DIA. Also, he chairs the panel, appointed by the UK Faculty in Pharmaceutical Medicine, overseeing the ‘Drug Safety Surveillance’ module as part of Higher Medical Training for pharmaceutical medicine in the UK. Currently he is leading a Pharmaceutical Human Factors group within ISoP and has also joined the UK Clinical Human Factors group. Currently Dr Edwards is Scientific Adviser in Pharmacovigilance and Drug Safety with NDA Regulatory Science Ltd based in Leatherhead, Surrey, UK.
• Upasana Prabakhar, Senior Pharmacovigilance Manager, NDA Regulatory Science Ltd
  
  

[ Register Now ]