7th Annual Pharmacovigilance Conference

Dr. Ashok Srivastava is Owner- Chief Executive Officer & Chief Safety Officer of Global Pharma Tek- a Pharma Drug Safety/Pharmacovigilance and IT, USA- Life Sciences; Chief Medical Officer and Co-Founder of Pharma Lynx- a CRO, USA, and also Chief Medical Officer of CareBeyond - A Radiation Oncology Services, USA. He has more than 15 years of experience in clinical drug development and drug safety in Oncology. He contributed to several INDs and NDAs. He received Clinical, Medical & Business educations and degrees from All India Institute of Medical Sciences, India; Czechoslovak Academy of Science, Czechoslovakia; School of Medicine Nagasaki University, Japan, and Pharmaceutical Business Rutgers University Business, New Jersey. Dr. Srivastava co-developed cancer drugs and vaccines- Sutent for GIST, Evoxac for head and neck cancer, liposomal doxorubicin (Myocet), herceptin, paclitaxel for HER2 positive metastatic breast cancer patients, and Japanese encephalitis vaccine.

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 steering group overseeing the implementation of the European Clinical Trial Directive.
Prior to that, 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 used to be Treasurer and member of the Executive Committee for the International Society of Pharmacovigilance (ISoP) and remains Director of ISoP Secretariat Ltd. Also, he chairs the panel, appointed by the UK Faculty in Pharmaceutical Medicine, overseeing the ‘Drug Safety Surveillance’ module as part of Pharmaceutical Medical Specialist 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.
At the moment, Dr Edwards is a Principal Consultant in Pharmacovigilance and Drug Safety with NDA Regulatory Science Ltd based in Leatherhead, Surrey, UK.

Carol Markwell has worked in Pharmacovigilance since 1988, being one of the first to gain the Postgraduate Diploma in Pharmacovigilance from the University of Hertfordshire. In industry, Carol managed a team responsible for international case management, UK/ Eire submissions and the preparation of up to 25 PSURs annually.
Now Carol is Director and owner of Drug Safety Solutions Ltd, a pharmacoviglance consultancy and small Contract Service Organisation, providing assistance and Pharmacovigilance solutions to pharmaceutical companies globally. She works with both large and small companies with generic, innovative and developing products, assisting with process review and optimisation; specification, implementation and validation of global safety databases; pharmacovigilance training, or even provision of a total pharmacovigilance service.

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 interfacing with major European organizations). She joined UCB in 1997 to drive implementation of Health Outcomes strategies in support of health economic dossiers, safety and efficacy claims and scientific communication.
In February 2009, Celestina was appointed Senior Director, Pharmacovigilance Data Quality Expert, Pharmacovigilance Quality Assurance, Corporate Quality Assurance in UCB.

Dr. Christina Ström Möller is Executive Director, Global Safety at Amgen Ltd. In this role, she is responsible for International TA Safety, proactively driving patient risk management strategies in the International region.
She has thirteen years of experience within the field of Safety Surveillance, including data-mining and patient risk management.
Dr. Ström Möller, who is Swedish, qualified as a physician in 1984 from the University Hospital in Lisbon, Portugal, after which she practiced at various hospitals in Sweden. She became a certified specialist in Anesthesiology and Intensive Care in Sweden 1993.
After some years as a senior consultant within the field of Anesthesia and Intensive Care, she joined the pharmaceutical industry, where she has worked as a Patient Safety Physician for drugs under development as well as marketed products. From 2007 to 2010, Dr. Ström Möller was Regional Director for Patient Safety in Asia for AstraZeneca, based first in Shanghai and later in Osaka.

Professional history in Roche:
Head of the French Drug Safety department from 1996 to 2002. In 1999, was nominated Qualified Person for Pharmacovigilance and expanded her role within Safety at a global level. From 2002 to March 2006, was appointed Global Head of Drug Safety Affiliates & QPPV. May 2006, back in the French Affiliate as the GM’s Executive Assistant for 6 months and became Head of Communication & Congresses in October 2006 as well as member of the French Executive Committee during this period. From October 2008 to February 2010, Deborah was the Head of Safety Risk Management Strategy developing relationships with the major Health Authorities (EMEA & FDA) and to represent Roche on advancing the science of Safety Risk Management (including Benefit/Risk qualitative and quantitative assessments. She is also the Coordinator of the Pharmacovigilance Teaching Program, one of the 18 streams of the Innovative Medicine Initiative (IMI), the European Technology Platform launched by the European Commission.
Since March 2010 Deborah is the Head of EU Regulatory Liaison supervising all European affiliates, Regulatory Intelligence as well as Networking and Policies in Europe.

She joined the Danish Medicines Agency and the EU Pharmacovigilance Working Party in 1998. In 2002 she became member of the European Risk Management Strategy Facilitation Group. Her regulatory experience comprises all aspects of pharmacovigilance, including scientific evaluation of drug safety issues, development of risk management strategies, policies and guidelines, provision of scientific advice to the pharmaceutical industry, cooperation with academia and communication to health care professionals and the public on drug safety concerns. She is strongly 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. In 2004 – 2008 she was a member of DIA Advisory Council for Europe.

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.
Enrica gained extensive Pharmacovigilance experience in Ciba and Novartis, 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.
Enrica has been Head of the Risk Management & Epidemiology Department in Merck-Serono since 2010.
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.

Dr. György Zörényi, MD, MFPM, is currently a senior safety physician in AstraZeneca UK. He qualified from the Medical School in Budapest, and has worked in Anaesthesia and Intensive Care for 8 years, including 5 years in a Heart Surgery Unit. As an assistant professor he taught anaesthesia, intensive care, cardiology and pharmacology at the Medical College of Health in Budapest and co-edited textbooks of anaesthesia, intensive care and pharmacology for health’s care professional students. He has been in pharmaceutical industry for 14 years in various roles, last 6 years in patient safety as global safety physician across oncology and anaesthesia. He has worked and advised on many drug safety issues including major safety hazards, due diligence and termination of clinical development. He also advised on the development of early phase and post marketing authorisation safety studies including pharmacoepidemiology studies. He has contributed to numerous PSURs, Risk Management Plans, regulatory submissions and label changes.
dr. György Zörényi is a Specialist of Anaesthesiology and Pharmaceutical Medicine, Member of the Faculty of Pharmaceutical Medicine. He is an Educational Supervisor and works in the Professional Standards Committee of the Faculty of Pharmaceutical Medicine.

Julia has over 10 years of experience in Pharmacovigilance and 8 years of experience in biomedical research. Since 2010 Julia is working as Nordic Drug Safety Manager at Johnson & Johnson Consumer Nordic and dedicating her efforts to implementing new legislation related to human and veterinary medical products, medical devices and cosmetic products.
Currently she is a member of PV Force Group at AESGP (Association of the European Self-Medication Industry) and taking an active role in Pharmacovigilance Committee at the Research-Based Pharmaceutical Industry Association in Sweden by proactively working with member of the committee to shape the regulatory environment and managing Nordic Pharmacovigilance issues.

Liam Smeeth is professor of clinical epidemiology at the London School of Hygiene and Tropical Medicine and a general practitioner in north London. Much of his research is based on making use of computerized clinical data both to investigate drug effects and disease etiology. His work is largely in cardiovascular disease, with one area of particular interest being the causal role of infections and inflammation. Other areas of interest are genetic epidemiology and non-communicable diseases in low income settings. He is involved in a range of activities for NICE and the NHS more widely.

Philippa has worked in the Pharmaceutical Industry for over 20 years, 19 of these being within Patient Safety at AstraZeneca. An experienced manager, Philippa has extensive experience across all aspects of safety for both marketed products and those in clinical development. In addition she has experience of leading the UK Case Handling Group, providing training and day to day support for all the local Drug Safety Officers worldwide, developing and implementing global processes and systems as well as leading the support for audits and regulatory inspections across all countries. Philippa joined 2Health later re-named Pure Drug Safety Ltd in June last year as Director of Drug Safety and providing EEA QPPV services to clients as required.

Dr Phillip Eichorn did his undergraduate work in Linguistics and anthropology at Harvard College and his medical studies at the University of Massachusetts Medical School. After ten years in an adult medicine practice in the Boston, Massachusetts, area, he joined Pfizer Labs, Ltd, at their United Kingdom site, and since then he has held a variety of positions in both the pre-approval and post-approval safety and benefit-risk management arenas. Currently he heads up the group that produces clinical documentation for regulatory authorities relating to Pfizer’s large portfolio of older, off-patent medications.

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 Drug Safety Research Unit.

Dr Jones worked as a hospital doctor in the UK National Health Service for five years in a number of specialties before joining the pharma industry in 2001. Since then she has worked in medical affairs, clinical research and pharmacovigilance in large pharma global R&D headquarters and local country offices, biopharma companies and academic institutions. Dr Jones maintains clinical sessions and has a special interest in education. She has experience of numerous therapy areas and product types and her expertise spans the entire product life cycle.
Dr Jones now provides medical services to the pharmaceutical industry through www.medicorum.co.uk

Dr Sumit Munjal graduated as a medical doctor from India. He gained clinical experience In India and worked as a clinical specialist in the field of Neurosciences in National Health Service (NHS), UK. He then went onto complete a Masters degree in Epidemiology from London School of Hygiene & Tropical Medicine (LSHTM). Following this, he worked as a Clinical Research Fellow at the Drug Safety Research Unit (DSRU), Southampton where he was involved with Pharmacoepidemiology studies. He then joined Medicines & Healthcare products Regulatory Agency (MHRA), UK as a Medical Assessor in the department of Vigilance and Risk Management of Medicines (VRMM) where he was involved in some important UK and international pharmacovigilance issues. He is currently working as a Consultant to Janssen Cilag Ltd, Johnson & Johnson, UK in their Global Medical Safety department for oncology products.