
| Amer Alghabban Head of GCP Auditing Group Merck Serono |
Amer completed his M.Sc in Pharmacology at Bradford University, Postgraduate studies in Medical Sciences at University College Hospital, Diploma in Biological Sciences from Salford University and Postgraduate Certificate in Clinical Research from Surrey University. Amer has over 20 years track record in the pharmaceutical industry (spent within ... more › |
3.50pm Day two
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| Felix Arellano VP, BSCP Global Vaccine Development GlaxoSmithKline Vaccines |
Dr Arellano is a medical doctor who is currently working as Vice-President, Head of Safety and Pharmacovigilance at GSK Biologicals Belgium. He completed his M.D. degree from the University of Madrid, Spain, followed by training in Pharmacoepidemiology from Mc Gill University in Montreal and a diploma in Pharmaceutical Medicine from the... more › |
2.30pm Day one stream two
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| Celestina Arrigo Senior Director, Pharmacovigilance Data Quality Expert UCB |
Celestina Arrigo has a PhD in Public Health and Masters in Epidemiology and Management gained at the Free University in Brussels. Celestina has over 25 years experience in Clinical Research, Epidemiology, Pharmacoepidemiology and Health Economics with more than 10 years experience in Public Health institutions (US NCI, National Institute of Health ... more › |
3.30pm Day two
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| Dr Pavan Badale Group Leader and Subject Matter Expert ICSR Pharmacovigilance Tata Consultancy Services |
Pavan Badale has over 6 years of total work experience; in various areas of ICSR as a case processing training, Drug Safety physician, Lead PV Physician, Subject Matter Expert and currently working as a Group lead for a Pharmacovigilance project. He is currently working with Drug safety Physicians and dedicated to promote continuous improvement... more › |
11.40am Day two
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| Véronique Basch Executive Director, Global Pharmacovigilance United BioSource Corporation |
Véronique Basch, PharmD, is the Executive Director, Pharmacovigilance for United BioSource Corporation and is based in Geneva, Switzerland. She manages the development, implementation, and execution of UBC’s safety strategy, providing direction, oversight, and management of its global Pharmacovigilance Team. Dr. Basch first gained international... more › |
9.50am Day one
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| Thomas Binnen Medical Specialist, Clinical Data and Knowledge Management, Global Clinical Data Center Bayer Healthcare |
01.99-06.02 Medical Study Coordinator at the Institute of Health Economics and Clinical Epidemiology, University of Cologne Director Prof. Dr. med. Dr. sc. Karl W. Lauterbach 07.02-03.03 Drug Safety Officer, PAION GmbH Aachen Corporate Drug Safety, SCHWARZ BIOSCIENCES GmbH Monheim: 04.03-12.05 Drug Safety Officer 01.06-07.06 Associate Medical... more › |
2.30pm Day one stream one
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| Gloria Bustos Director Pharmacovigilance Southern Europe EMEA SDEA Coordinator Baxter |
Gloria Bustos is PhD in Pharmacy by the University of Valencia, Spain. Since 2006 she is Pharmacovigilance Director for Baxter HealthCare Corporation in charge of Southern Europe. She is responsible for direction of Pharmacovigilance function in the region including development, management and implementation of standards. In her role, she actively ... more › |
3.10pm Day two
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| Roland Chen Vice President, Medical Safety Assessment / Strategic Capabilities BMS |
Roland Chen, M.D. is Vice President, Medical Safety Assessment and Strategic Capabilities at Bristol-Myers Squibb. He currently leads medical safety assessment efforts for the Cardiovascular / Metabolics therapeutic areas and also oversees efforts to build and enhance signal detection and refinement capabilities at BMS. He has previously held... more › |
3pm Day one stream one
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| Barbara de Bernardi Deputy EU QPPV Pfizer |
more › |
12pm Day one
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| Omer De Mol VP Pharmacovigilance and Medical Information, Europe Genzyme |
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| Michael Derby DO, PhD Safety Science Leader, LEAD Early Clinical Safety, Global Safety Risk Management Genentech |
Dr. Derby is currently works in LEAD Safety Science with Genentech Research and Early Development, in South San Francisco, California. In this role, his responsibilities focus on ensuring the safety of human subjects in early clinical trials (from exploratory model systems, biomarker studies, and human studies up through a demonstration of... more › |
9am Pre-conference seminar
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| Vicki Edwards QPPV/Senior Director, Affiliate Vigilance Excellence Abbott |
Vicki Edwards qualified as a pharmacist in 1981 and started her career in hospital pharmacy. In 1983 she specialised in Drug Information Services and moved to Kuwait to set up and run the first National Drug Information Centre. The Centre became a showpiece for the Ministry of Public Health and every visiting health related dignitary was taken... more › |
9.20am Day one
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| Michael Forstner Process Development Leader; Chair Risk Management WG f.Hoffmann La Roche |
Dr. Michael Forstner is “Integrated Safety Risk Manager” at F. Hoffmann-La Roche in Basel. In this role his main duties are to develop and implement processes for the coherent and consistent global management of drug safety risks together with his colleagues at other Roche drug development sites. These processes include data driven, integrated... more › |
9.40am Day two
10.50am Day two
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| Alastair G Fowkes Associate Director AstraZeneca |
Alastair Fowkes has over 20 years experience in pharmacovigilance and has worked extensively in the area of safety systems for the last 10. He has worked on or led three safety system implementation projects and two ICH E2B implementation projects. He has been working with the ICH E2B standard since 2000 and is currently the EFPIA Topic Leader... more › |
2.20pm Day two
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| Stewart Geary Vice President, Global Safety Officer Eisai |
E. Stewart Geary, M.D, has worked at Eisai since 1996 in pharmacovigilance, clinical safety and regulatory science. He is currently a member of the CIOMS IX Working Group on Medicinal Product Risk Management, the Executive Committees of the Japanese Association of Pharmaceutical Medicine and the International Federation of Associations of... more › |
1.50pm Day two
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| Apurva Goswamy CEO Quantum Solutions India |
Dr. Apurva Goswamy is the founder and CEO of Quantum Solutions India. He has over 26 years of experience in international research and Drug Safety, including nine years in international Quality Management. Having pursued higher education in Switzerland at the Universities of Zurich and Basel, he graduated with a Ph.D. in Cell Biology from... more › |
4.50pm Day one afternoon
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| Philippe Guillet Senior Director, Worldwide Head HealthCare Technologies for Aging Sanofi |
Following his medical studies at the Pitié-Salpétrière Hospital, Dr Philippe Guillet specialized in Geriatrics and Gerontology and practiced for about 10 years at the Charles-Foix Hospital, the largest Geriatric Hospital in France. He then joined the Pharmaceutical Industry and spent his carrier in the Clinical Development field, participating... more › |
3pm Day one stream two
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| Dr Craig Hartford VP, Head of product Safety Surveillance and Risk Management function in Pfizer's New York HQ Worldwide Safety function, involved with safety signal management and risk management Pfizer |
Dr Craig Hartford (MD, PhD) has extensive experience in major pharmaceutical company Pharmacovigilance, Benefit-Risk Management, Strategic Leadership, and prior external experience as a Clinical Investigator for several major Pharmaceutical Companies, plus direct clinical experience within underprivileged communities. Dr Hartford joined Pfizer... more › |
2pm Day one stream one
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| Jean-Marie Heim Director of Safety Assessment Bristol-Myers Squibb |
Jean-Marie Heim, MD is currently Medical Director, Safety Assessment, responsible for the global cardio-vascular and metabolic mature BMS portfolio, handling over 20 drugs. He is a trained physician from the Brussels University specialized in Clinical Toxicology (thesis on organophosphate neurotoxic agents). He was involved during 2 years in... more › |
11.40am Day one
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| Simon Henderson Senior Toxicologist Biologics Safety Assessment MedImmune |
Simon obtained his PhD from the University of Liverpool and gained 17 years experience in drug development within the contract research industry (Huntingdon Life Sciences). Originally with a background in Drug Metabolism and Pharmacokinetics, Simon spent many years managing non-clinical safety programmes for small molecules and biopharmaceuticals... more › |
9.45am Pre-conference seminar
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| Astrid Herpers Head of EU-QPPV office, EU-QPPV Boehringer Ingelheim |
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| Ute Hoeffner EU QPPV Novartis |
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12.20pm Day one
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| David Kallend Global Clinical Leader and PD Group Medical Director Roche |
Dr David Kallend trained in medicine at King’s College London and King’s College Hospital, qualifying with an MBBS from the University of London in 1988. Following this he trained in surgery, predominantly at the Royal Postgraduate Medical School in London where his final post was as a Research Fellow in the Department of Surgery. During this... more › |
2pm Day one stream two
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| Rachna Kasliwal Director Pharmacovigilance, Endocrinology Ipsen |
Rachna Kasliwal is currently working as Director Pharmacovigilance, Endocrinology at Ipsen BioPharma. Her background is in Medicine and Public Health. She has worked in Pharmacoepidemiology/Pharmacovigilance since 2004 and has a number of publications in this field. Before joining Ipsen she has worked at GlaxoSmithKline and at the Drug Safety... more › |
5.40pm Day one afternoon
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| Gro Laier Deputy QPPV, International Product Safety Novo Nordisk |
• Medical doctor 1987 • 7 years of experience within toxicology • 16 years of experience within Pharmacovigilance • 2½ years at the Danish Medical Agency • 1½ years at H. Lundbeck • 12 years at Novo Nordisk • 11 years in HQ Global Safety • 1 year in NNI (NN USA) Product Safety • Deputy QPPV since June 2005 • Also manager 2006-8 (1½ year) more › |
5.40pm Day one afternoon
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| Genevieve Lapeyre Head of Drug Safety NoVimmune |
Dr Geneviève Lapeyre is a former associate professor anesthesiologist and intensive care specialist from Paris and has more than 20 years experience working in Clinical Development, Medical Affairs and Pharmacovigilance/Risk Management for international big pharma companies including Pharmacia-Pfizer, Roche and Alcon (part of the Novartis... more › |
11am Pre-conference seminar
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| Ennis Lee Vice President, QPPV Pharma, Johnson and Johnson |
Dr Ennis Lee qualified from Westminster Medical School and practised in the NHS in general medicine and medical oncology. Dr Lee joined the pharmaceutical industry over 25 years ago and has worked for several major pharmaceutical companies, in all phases of drug development. Her work included 5 years working for the UK regulatory authority, then ... more › |
9am Day one
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| Anngret Mallick Group Head TAG Cardiovascular/Hematology, Global Development - Global Pharmacovigilance RM Bayer Healthcare |
Anngret Mallick is a physician with 17 years of clinical experience and certifications in inner medicine and nephrology and her last position has head of dialysis before switching to industry in 2008. She is heading the Cardiovascular/hematology risk management group at Global Pharmacovigilance, Bayer Helathcare Pharmaceuticals since 2011 and is a ... more › |
3pm Pre-conference seminar
5.40pm Day one afternoon
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| Zsuzsanna Mueller Senior Manager Pharmacovigilance, Clinical & Medical Affairs Intercell |
Zsuzsanna studied Nutritional Sciences at the University of Vienna. She worked at Abbott for 5 years as Scientific Manager Nutrition and Quality Assurance Manager, before changing to Intercell, where she supported the development of the Pharmacovigilance and Medical Information System before the first product was approved. She is now responsible... more › |
3.10pm Day two
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| Sumit Munjal Consultant Physician J&J |
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| Ralph Nies Vice President Drug Safety & Pharmacovigilance Astellas Pharma Europe R&D |
Ralph is 49y old and is a physician by training . He has worked for 6 years in hospital, before he joined the Pharmaceutical Industry in 1998 as a Pharmacovigilance Physician for Chiron-Behring (now Novartis Vaccines) in Marburg (Germany). From 2001 on he was the head of the PV department for Eli Lilly in Germany and acted also as local QP for... more › |
11.20am Day one
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| Dr. Mirza I Rahman Senior Director, Pharmacovigilance Merck |
Dr. Rahman is currently a Senior Director & Clinical Risk Management Group Leader in the Global Safety Department at Merck & Co., Inc. He is also a practicing physician at the Concentra Occupational Medicine & Urgent Care Medical Centers, and is a volunteer attending physician at the Bryn Mawr Family Practice Residency... more › |
12.10pm Day two
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| Sue Rees Head of Pharmacovigilance and Medical Information and EU QPPV Eisai |
Sue is currently the Head of Pharmacovigilance & Medical Information and acts as EU QPPV for Eisai Europe Ltd. In this role Sue heads up a team of scientists and physicians responsible for all aspects of global safety for Eisai’s oncology and GI portfolio. Sue is also accountable for safety across the Europe region through a network of Local... more › |
9.20am Day two
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| Michael Richardson Vice President, International Pharmacovigilance and EU QPPV BMS |
Michael Richardson has over 25 years of global management experience in research based life Sciences companies. He has worked in major multinational companies’ across the globe both at a Regional management level and heading up Research and Development in Asia. Currently International Head of Bristol Myers Squibb’s Pharmacovigilance Function and... more › |
9am Day two
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| Rudi Scheerlinck Executive Director, Integrated Medical Safety, Oncology Novartis |
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12.40pm Day one
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| Dr. Eleanor S. Segal Biopharmaceutical consultant Consultant |
Dr. Eleanor Segal (“Ellie”) is a family physician and geriatrician who was a clinician/teacher for over 20 years before joining the pharmaceutical industry (Syntex) in 1991. A graduate of the University of Michigan Medical School, she is board-certified in family medicine, a Fellow of the American Academy of Family Practice, holds a Certificate... more › |
8.50am Pre-conference seminar
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| Dr Henry Seto Vice President Global Patient Safety Vertex Pharmaceuticals Inc. |
Dr. Shui Ki Henry Seto graduated from Tufts University and received his medical degree from Tufts University School of Medicine in Boston, Massachusetts. He completed his internship and residency in Internal Medicine from New England Deaconess Hospital, Harvard Medical School. After completing his fellowship in Cardiovascular Medicine at... more › |
4.50pm Day one afternoon
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| Dr Shirish Sherlekar Global head life sciences practice Tata Consultancy Services |
Dr Shirish D Sherlekar is a trained doctor by profession. He has worked for five years at the P.D. Hinduja Hospital and Research centre as a resident surgeon and the Hospital of the Kaiga atomic power plant as a Medical director before shifting to the pharmaceutical industry in 1991. Since joining the industry in 1991 he has worked in both... more › |
8.55am Day two
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| Doris Stenver Chief Medical Officer; Member Danish Health and Medicines Authority; Pharmacovigilance Risk Assessment Committee (PRAC) |
Education- 1986 Medical Degree from Copenhagen University, the Faculty of Medicine 2007 Master Degree in Public Administration, Copenhagen Business School. Clinical Experience- During 12 years (1986-1998) she worked at university hospitals in the Copenhagen area, and in 1995 she became specialist in internal medicine. Her clinical experience... more › |
4.10pm Day two
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| Christina Stroem-Moeller Head of GMD Late Development & Marketed Products EU AstraZeneca |
Dr. Christina Ström Möller is currently Head, Patient Safety Late Development and Marketed Products, Europe, AstraZeneca. In this role, she is responsible for ensuring the delivery of high quality medical and scientific patient safety expertise to assigned products. She has twelve years of experience within the field of Safety... more › |
5.40pm Day one afternoon
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| Fernanda Tavares Da Silva Therapeutic Area Safety Head, Adjuvants in Vaccines & Immunotherapeutics GSK Biologics |
Dr Tavares obtained her MD degree and has a specialty in Obstetrics and Gynaecology from the Central University of Venezuela (1992). She has over 19 years of clinical/medical and pharmaceutical experience. Dr. Tavares has held various roles at GlaxoSmithKline Biologicals including Clinical Development and Pharmacovigilance , since 2005. She is... more › |
1.30pm Pre-conference seminar
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| Pentti Timonen Senior Director Pharmacovigilance Crucell B.V. |
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| Phil Tregunno Unit Manager MHRA |
Phil studied Biological & Medicinal Chemistry at the University of Exeter and joined the MHRA (Medicines and Healthcare products Regulatory Agency) in 2003. For the past 5 years he has been responsible for leading and developing the Signal Management function, including both systems and processes, and more recently relevant aspects of the new... more › |
5.20pm Day one afternoon
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