Vivianne Arencibia is the Vice President and Global Head for Novartis Global Compliance and Audit for Novartis Group Quality Operations. Her responsibilities include oversight and management of quality audit and compliance initiatives globally across the Novartis group companies (Pharma, OTC, Generics, Vaccines and Diagnostics and Animal Health) across the GxPs. In her role, she is responsible for quality and compliance policy, inspection management, risk based audit management, auditor training, certification and standards. She has been with Novartis since 1997 in key leadership positions where she successfully implemented global quality systems across GMP, GCP and Pharmacovigilance areas and working with regulatory authorities worldwide.

Dr. Balian joined BMS in late 2005 to head the Global Pharmacovigilance and Epidemiology (GPV&E) organization at Bristol-Myers Squibb. During this period, in view of the serious challenges, scrutiny, and new regulations facing drug safety globally, GPV&E at BMS accomplished a complete transformation of its structure, procedures, practices, and strategies to ensure focus on patient safety. One key feature of the new strategy is accessing global talent and expanding operations to India as an industry first of its kind. Dr. Balian was promoted to Senior Vice President in August of 2007. In 1998 Dr. Balian joined Pfizer as an Associate Director in Drug Safety. He became a Director in 2000 and in 2001 promoted to VP, Worldwide Head of Clinical Safety & Risk Management, where he led the clinical safety organization, including regulatory safety compliance, epidemiology, risk management, and summary strategic documentation. In 2003 Dr. Balian was appointed VP, Worldwide Head of Project Planning and Performance at Pfizer, leading a multi-functional organization responsible for sourcing strategies, capacity planning, trial allocation, performance measures, and business/operational support for all clinical trials.

Dr. Beasley’s internship was in the Department of Psychiatry, Yale University and he completed his training in psychiatry at the University of Cincinnati in 1987. He immediately joined Eli Lilly and Company in the area of clinical development of psychiatric medications. He was responsible for Prozac from the time of its US launch through 1991 working extensively on the topic of the potential for SSRI medications to induce suicidality. During this period of time he was also responsible for the development program for atomxetine as an antidepressant (program terminated) during which he developed a particular interest in placebo response and trial design. From 1991 through 2001 he was responsible for the development of Zyprexa as a treatment for schizophrenia. From 2001 through 2002 he served as Medical Director for Cialis. Since 2003 he has served as a consultant across all therapeutic areas in both experimental design and safety, initially from a position in the Neuroscience area and since 2004 in Global Patient Safety. He has particular interest in three areas of safety: suicide; hepatic dysfunction; and delay in cardiac ventricular repolarization and the design of “Thorough QT Studies”. His interest in ventricular repolarization derives from work with academic collaborators on the characterization of multiple cardiac ion channel blockade by antipsychotics beginning in 1995 and the design of one of the first “Thorough QT Studies” required for regulatory approval of Cialis in 2000.

Phil Berry qualified in Medicine through the University of Sheffield in 1989 and held a variety of NHS positions, latterly in Accident & Emergency medicine, before entering the Pharmaceutical industry as a Regional Medical Advisor for Novartis Pharmaceuticals in Surrey in August 2001. In May 2003, Phil then moved to head the Medical Affairs and Pharmacovigilance departments at Boots Healthcare International’s Headquarters in Nottingham. In this role he managed a team of eight Head Office based staff and forty staff in offices around the globe. Since February 2006 he has been the Global Medical Director for Reckitt Benckiser Healthcare International where he holds the position of European Qualified person and has organisational accountability for Global Pharmacovigilance, Global Clinical and Global Medical He led his organisation through one of the first mandatory MHRA Pharmacovigilance Inspections during November 2003 and a return routine inspection in March 2007. He has spoke at numerous conferences on how to prepare and manage a pharmacovigilance inspection.

Mr. Blackwell has over 25 years experience in the delivery of computer systems solutions for pharmaceutical development. He is a director within Phase Forward's Lincoln Safety Group. Over the past several years Mr. Blackwell has worked along with other colleagues from the Lincoln Safety Group with innovative pharmacovigilance teams to integrate quantitative signal detection into routine safety monitoring operations. These engagements include projects for the UK MHRA, the US FDA, GSK and AstraZeneca. Mr. Blackwell also oversees projects to leverage the CDISC SDTM clinical data standards to facilitate safety review of clinical trials and projects to implement the ICH E2b/M2 standards. Prior to his work with the Lincoln Safety Group, Mr. Blackwell held a series of similar positions with other pioneering organizations in software tools for clinical research including Belmont Research, BBN Software Products and Bolt Beranek and Newman Inc. (BBN). Mr. Blackwell was first introduced to this area in the course of a project to develop a time oriented database for use in the General Clinical Research Centers funded by the US NIH. Mr. Blackwell pursued undergraduate studies in computer science at the Massachusetts Institute of Technology.

Carmen Bozic MD is Vice President and Global Head of Drug Safety and Risk Management at Biogen Idec. She joined Biogen Idec as Associate Director, Medical Research in 1998, where she managed clinical trial programs in multiple therapeutic areas for several years. Carmen led the development of the risk management plan for TYSABRI (natalizumab) and presented on this topic at a recent FDA Advisory Committee. Carmen received an MD degree and did her residency in internal medicine at McGill University in Montreal, Canada, completed a fellowhip in Pulmonary and Critical Care Medicine at Brigham and Women’s Hospital in Boston, and was an attending physician at Beth Israel Deaconess Medical Center and Harvard Medical School before joining Biogen Idec.

Andrew started work as a Pharmacologist at the University of Leeds conducting research on genetic cancer therapies. In 1997, he conducted early analysis on results from the Human Genome Project (HGP). Through his work with the HGP genetic databases, Andrew moved to Oracle Corporation in 1998 where he worked as a Consultant advising a wide variety of Life Sciences companies during their implementation of Oracle's Clinical Data Management and Dictionary Management systems. Following Oracle's acquisition of EventNet (now the Oracle Adverse Event Reporting System) in 2002, Andrew moved to a Solution Architecture position with a specific focus on Oracle's Drug Safety solutions. As a Solution Architect, Andrew worked across Europe discussing with Heads of Drug Safety on how IT solutions can assist with business issues and regulatory requirements. Today, Andrew manages a specialised team of Solution Architects within Oracle's Health Sciences Global Business Unit.

Scott Cunningham is a member of Covington's Food and Drug practice group. He represents pharmaceutical, biotechnology, and medical device companies as well as trade associations in matters before the United States Food and Drug Administration, Congress, state and federal courts, and other U.S. regulatory and enforcement agencies. Mr. Cunningham has significant experience in areas including new product development and clinical trials; new product approvals; Hatch-Waxman exclusivities and product life-cycle management; post-approval drug safety; advertising and promotion; compliance issues and pharmaceutical investigations; Orphan Drug; paediatric exclusivity; manufacturing and cGMPs; import/export; controlled substances; SEC disclosure; and other aspects of federal and state regulation of pharmaceuticals, biologics, and medical devices. Mr. Cunningham also has an active pro bono practice where he regularly serves as a Guardian ad Litem representing children in child custody cases.

Dr Sarah Daniels is an Independent Pharmacovigilance Consultant. Between October 2006 and June 2008 she was the European Union Qualified Person for Pharmacovigilance (EU QPPV) for Roche Products Limited, based in Welwyn Garden City in the UK. During this period she led the implementation of the Volume 9a guidelines and participated in several PV Inspections. Prior to joining Roche in 2005 as the Head of UK Drug Safety Centre and Deputy EU QPPV, she was the UK Medical Director for ConvaTec (a division of Bristol-Myers Squibb) based in Ickenham. Dr Daniels joined the Pharmaceutical Industry, initially as a clinical pharmacologist with SmithKline Beecham (now Glaxo SmithKline). Subsequently, during her 10 year stint with SmithKline Beecham, she held a variety of other positions, including latterly, Director of Medical Affairs. Her experience spans pharmacovigilance, drug development and medical affairs. She is a registered physician who qualified in medicine at the University of Ghana in 1982. Thereafter she trained as an anaesthetist and intensive care physician in the UK’s National Health Service (NHS). Her last NHS appointment was with the University College Hospital, London,

Magda is Head of PV Inspectorate Unit at Afssaps since Jan 2007 . She has performed a number of Pharmacovigilance inspections on behalf of Afssaps and EMEA since September 2005 . Magda was a GMP inspector from Nov 2002 - Mar 2007 (Biological Medicinal Product division), and worked in R&D from 1997 - 2002: (biotechnology and tissue engineering).

Dr. Doi is Chief Executive of the Society of Japanese Pharmacopoeia(SJP). Before this he was the Senior Executive Director of the Pharmaceuticals and Medical Devices Agency(PMDA), the Councilor for Pharmaceutical and Medical Safety of the Ministry of Health and Welfare(MHW), the Director of the Narcotics Division, Safety Division, New Drugs Division, First Evaluation and Registration Division of the Pharmaceutical Affairs Bureau. He was one of founders of ICH and promoted global harmonization process.

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 to see the activities of the new project. After a slow start the centre began to provide a valuable information service to healthcare professionals in Kuwait. Unfortunately the project came to an abrupt end in 1991 with the advent of the first Gulf War. On her return to the UK Vicki spent the next four years in community pharmacy. Working for the large chain of retail chemist she worked closely with general practitioners, local nursing homes and a cancer hospice to provide pharmaceutical services to the local patient population. In 1996 Vicki joined GlaxoWellcome and started her career in pharmacovigilance. In 2000 Vicki joined AstraZeneca where she was Head of Drug Safety and Medical Information. Vicki is currently Senior Director, European Pharmacovigilance at Abbott Laboratories.

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 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 Dr Edwards is based with NDA regulatory Science Ltd based in Leatherhead, UK

Dr. Zhao has a strong medical education and research background. I have more than 20 year medical research and more than 10 years pharmaceutical industry experiences. In the last 12 years, he worked in health outcome, pharmacoepidemiology, pharmacovigilance, drug safety areas in three large pharmaceutical companies. During this period, he published more than 150 abstracts and manuscripts. Currently, he is executive direction in Amgen Global Safety organization. His main responsibilities are: Head of PV-Epi group and Process Owner of safety surveillance leading safety surveillance process development and improvement.

Georg Ferber studied Mathematics in Stuttgart and Bochum (Germany). Before joining Sandoz Basle in 1984 he spent 10 years at the Medical School in Hannover with research in the analysis of the clinical electroencephalogram. At the same time he finished a doctoral thesis in Pattern Recognition at the Faculty of Electrical Engineering of Hannover Technical University. Since 1990 he has been working as a Statistician with Sandoz, Innovex and later Novartis. He is currently Head of the Basle Cardiovascular Biostatistics Group at Novartis. Since 2002 he has also been involved in cardiac safety and has been a member of the PhaRMA QT Statistical Experts Team and the QT ICH statistics discussion group.

Dr. Ferguson is Vice President and Global Head of Pharmacovigilance and Medical Safety at Novartis Vaccines and Diagnostics. He is a board certified Cardiologist who received his training in Cardiology and Clinical Epidemiology at McGill University, McMaster University and Cedars-Sinai Medical Center. Prior to entering the pharmaceutical industry, his research focused on expert systems, risk prediction in coronary artery disease and catheter-based interventions for prevention and treatment of ischemic stroke. He is an active participant in industry organizations, having served on clinical trial, safety, risk management and benefit-risk management committees at PhRMA and BIO.

Arnold I. Friede is counsel to the law firm of McDermott Will & Emery LLP based in its Washington, D.C. office. Arnie is a member of the Firm’s Health Law Department. Arnold I. Friede is a widely respected food and drug law counselor and advocate with significant advertising law, health care law, First Amendment, environmental, and commercial and transactional experience. He has a long history of direct involvement in successfully representing clients in FDA-regulated matters beginning as an Associate Chief Counsel in the FDA Chief Counsel’s Office, as well as a broad spectrum of senior in-house legal experience across multiple FDA-regulated industries. Arnie has had a distinguished career of highly responsible, diverse, and complex positions. He served in government as a law clerk in Federal District Court in Los Angeles, and then with the Federal Judicial Panel on Multidistrict Litigation in Washington, DC, and as an Associate Chief Counsel in the FDA Chief Counsel's Office in Rockville, Maryland. Afterwards with Richardson-Vicks in Wilton, Connecticut, and then with several divisions of Unilever United States, including as General Counsel of Unilever’s U .S. food business in New Jersey, and then as senior corporate counsel with Pfizer in New York, Mr. Friede has been involved for nearly 35 years in a broad range of FDA and other agency-regulated businesses, including the life sciences, such as pharmaceutical and biotech, medical device, medical information, disease management, and over-the-counter drugs, as well as in the food, cosmetic, chemical and other industries. He has a breadth and depth of experience across an array of substantive legal areas and business operations.

Dr. Janet Hormbrey has been the EUQPPV for Merck Sharp and Dohme since December 2006. She has 20 years experience with the Pharmaceutical industry, 14 years based in the US, and through her Industry career has been involved in management of many aspects of Clinical Research and Medical Affairs, with extensive experience in the practical aspects of implementing new clinical research and PV directives . She has managed subsidiary medical departments, including PV, regulatory and clinical research personnel across the European region, and other Ex EU countries for her company. She is a Physician , a member of the Royal College of Physicians and fellow of the Royal College of Pharmaceutical Physicians. She has participated in expert working groups for EFPIA, including Risk Management Planning. She has authored an EFPIA position paper on Post Authorisation Safety Studies.

Professor Juhana E. Idänpään-Heikkilä holds an MD and PhD (in pharmacology) from the University of Helsinki in Finland. He practiced medicine as a health center and hospital physician before moving to teach pharmacology at various universities. After a Visiting Professorship at the University of Baylor in Houston, Texas, in 1968-1969 and a post of Assistant Professor post at the University of Oulu, Finland, he worked from 1971 to 1990 as a Chief Medical Officer at the national medicines control agency in Finland. In 1982-1983, he was an adviser in drug regulation at the US Food and Drug Administration (FDA) in Rockville, Maryland, USA and in 1988-1989 worked as an adviser at the United Nations Office in Vienna, Austria. In 1990, he was appointed Deputy Director and subsequently in 1995 Director of the Division of Drug Management and Policies of WHO in Geneva, Switzerland. He also acted as Secretary of the WHO research ethics committee. In 2000, he received the honorary title of Professor from the President of Finland. He is the author of more that 200 scientific and other publications.

Stewart was born, raised and educated in Scotland and graduated from Glasgow University in 1981. Following emigration to New Zealand, he worked as a rural GP for 6 years before joining Medsafe in 1993. Medsafe is the medicines regulatory authority for New Zealand. Stewart is the Interim Manager and Principal Technical Specialist in Medicines Regulation and Pharmacovigilance at Medsafe and has a unique insight into the process of therapeutic products regulation. He has been involved in several projects to develop regulatory frameworks for New Zealand. Stewart advises several Ministerial expert committees, including the Medicines Adverse Reactions Committee. Stewart has an integral role in the pharmacovigilance activities conducted by Medsafe.

Dr Gary Lacey is the Head of the Adverse Drug Reactions Unit at the Therapeutic Goods Administration (TGA). Dr Lacey has worked at the TGA for 12 years in various roles, having joined as a preclinical toxicology evaluator in 1996. Dr Lacey obtained a PhD in neuropharmacology from the University of London and immediately prior to joining the TGA was employed as a Research Fellow at the John Curtin School of Medical Research at the Australian National University. This followed several years working in academic research in the UK and for the pharmaceutical industry in Switzerland.

William C Maier MPH, PhD, is Director/CEO of MAPI-EPI (www.mapi-epi.com), an organisation providing epidemiology and risk management services to the global pharmaceutical, biotechnology, medical device and consumer products industries. In a partnership with ProSanos, MAPI-EPI is able to provide the drug safety community with a new software tool to analyse spontaneous events and observational data together to better understand drug safety signals. Dr Maier has over 20 years of experience in the pharmceutical industry and academic appointments in the UK and USA. He has expertise in the development of pharmacovigilance and risk management plans, the design and execution of observational studies, and negotiation with international regulatory authorities. Last year he presented the Tysabri Risk Management Plan for Crohn’s Disease at an FDA advisory committee. This product was approved for use in CD by the FDA in early January, 2008

Formerly a practicing veterinarian in New Jersey and Maryland, Dr. Milne later attended Johns Hopkins University where he earned a master’s degree in public health with a concentration in epidemiology and health statistics. For six years, he worked for the New Jersey Department of Health, initially as a researcher in health risk assessment, later in legislative and regulatory review as Manager of the Public Response Program, and finally as Emergency Response Coordinator. In 1997, Dr. Milne graduated from law school, became a licensed attorney, and soon after, joined Tufts University’s Center for the Study of Drug Development (Tufts CSDD) as a Senior Research Fellow. His current research interests include: challenges to the R&D of new medicines; the role of outsourcing in drug development; and, trends in FDA and EMEA regulatory and policy initiatives. He is currently Associate Director of the Tufts CSDD.

Guy Pawson received his doctorate in Human Biology at the Pennsylvania State University and taught for several years in the Departments of Pediatrics, Epidemiology & International Health at the University of California School of Medicine in San Francisco. He is now manager of electronic regulatory submissions at Genentech Inc. and works with various project teams in the design, creation and delivery of BLA and NDA submissions. He has been directly involved in all Genentech’s previous electronic filings and now has primary responsibility for preparing the clinical and non-clinical data and CRF components and overseeing their integration into the final BLA package.

Following completion of Medical School and subsequent postgraduate training at Harvard University in Boston MA, and Mount Sinai Medical School, New York, Dr. Petchel worked in the pharmaceutical industry at varied positions, including late Phase III research activities, Medical Affairs and Safety. With Pfizer she was responsible for global strategic direction and coordination of safety operations in all worldwide countries. Immediately prior to this position she served as Pfizer ‘Qualified Person’ for Pharmacovigilance in the EU and directed the EU team who managed expedited and PSUR safety reporting, postmarketing safety studies, and various risk management initiatives in assessment activities. Dr Petchel also led efforts for Pfizer in global safety harmonization and was a regular participant with ICH activities in Pharmacovigilance Planning. In 2006, Dr. Petchel assumed the responsibility of Vice President, Global Head of Drug Safety Risk Management at Roche Pharmaceuticals in Nutley, New Jersey. She is responsible for all of Drug Safety globally and leads global staff of more than 550 .

Dr. Sabine Richter has more than 18 years experience in clinical research in the pharmaceutical and CRO industries. As the current Vice President, Safety and Risk Management and as a former Project Director for pharmacovigilance projects at PRA International, she developed contract language and quality control measures to ensure consistent high performance and regulatory compliance.

Raymond Schlienger, PhD, MPH is a senior epidemiologist at Global Clinical Epidemiology of Novartis Pharma. He received his diploma in pharmacy in 1989 and a PhD degree in pharmaceutical sciences from the University of Basel, Switzerland in 1995. After a two-year postdoctoral training in clinical pharmacology and drug safety in Toronto, Canada, he became the head of the drug information service and the regional pharmacovigilance center of the University Hospital Basel. Additionally, he was a research associate at the Basel Pharmacoepidemiology Unit. During that time he also finished his training as a clinical pharmacologist and pursued a postgraduate training in public health at the Universities of Basel, Berne and Zurich. In 2005 he was habilitated as private lecturer (associate professor) at the Medical Faculty of the University of Basel. End of 2005 he joined Global Clinical Epidemiology of Novartis. He currently holds the position of the lead epidemiologist within the cardiovascular & metabolism business franchise. He has published more than 50 articles mostly dealing with different aspects of drug safety and pharmacoepidemiology.

Hugo Stephenson, MD, is President of iGuard.ORG a new service offered by Quintiles Transnational Corp. Prior to his appointment as president of iGuard, Stephenson had been Senior Vice President of Quintiles' Strategic Research and Safety services, a position he held since joining the company in 2003. Stephenson was the founder of Health Research Solutions, an Australian strategic research service provider acquired by Quintiles in 2002. He has a particular interest in strategic epidemiology and risk management, and he works closely with senior industry strategists to promote the use of strategic research activities to support advances in pharmaceutical research.

Dr John Talbot is Director Patient Safety, Processes & Standards based at AstraZeneca R&D Charnwood in Loughborough UK. John has been with AstraZeneca (and formerly Astra) since 1996 initially leading the Drug Safety function at one of its R&D sites and now having a global role encompassing Patient Safety processes and standards across the organisation. Before joining Astra, John was Head of the Spontaneous Reports Group, International Product Safety and Pharmacovigilance at GlaxoWellcome having worked with both investigational and marketed products over the past 15 years at Glaxo.

Mr. Shigeki TSUDA, received his Master degree of pharmacy from Hokkaido University in 1983. Then he joined the (then) Ministry of Health and Welfare, and experienced a number of posts including those related to quality and safety of medicines and international affairs. He spent 3 years in PMDA as Director of International Affairs/ Human Resources Development Division. In 2007, he left the government to join the Society of Japanese Pharmacopoeia.

Studied medicine and received his degree in 1987 at the Erasmus University of Rotterdam, the Netherlands. After several years of working as a practising physician, he joined the pharmaceutical industry with Ciba-Geigy in Basel, Switzerland. He worked as an epidemiologist in the unit for drug safety monitoring. During this period he completed a Master of Science degree (Pharmacoepidemiology) at McGill University, Canada. In 1992, van Staa started to work for Procter & Gamble Pharmaceuticals. He was the Qualified Person for Drug Safety in Europe for Procter&Gamble Pharmaceuticals and executive member of the worldwide labelling committee. He was involved in several safety issues and his organisation successfully underwent regulatory inspections. Van Staa was also responsible for the conduct of epidemiological and pharmacoeconomic studies and involved in NICE submissions. In 1999, a PhD in Pharmacoepidemiology was awarded at Utrecht University. In 2006, he joined the Medicines and Health products Regulatory Agency as head of research of the General Practice Research Database. He has published over 50 peer-reviewed articles and is a well-recognised speaker in the field of osteoporosis, pharmacoepidemiology and pharmacovigilance.

Ms. Yamasaki is qualified in Pharmacy and Biochemistry from the University of Sao Paulo in Brazil (USP). She had an internship at a Hematology laboratory for 2 years. Initially, this internship was voluntary, but after a year, it became a project sponsored by The State of Sao Paulo Research Foundation (FAPESP). During this period, time was dedicated to the study of red blood cells, which resulted in a co-authored publication at the British Journal of Obstetrics & Gynecology (BJOG) in 2002. After this academic experience, she joined the pharmaceutical industry where she has been working for more than 6 years with pharmacovigilance. She started at Novartis Brazil, handling the safety of oncology, CNS and transplantation drugs and now she works for Stiefel Laboratories Inc., a dermatology-focused specialty pharmaceutical company. Based in Brazil, R&D Latin America, as the region representative of the Stiefel Global Pharmacovigilance Team, Katia oversees the pharmacovigilance in Latin America, coordinates the reporting of safety information to regulatory agencies and ensures that all the company subsidiaries are provided with appropriate support and guidance. She is also responsible for training strategies for the area to deliver continuous high quality drug safety operations.