SPEAKERS

Dr. Herve Laurent , Senior VP SRS Europe , Quintiles

Simon Sparkes, Aris Global

Bernard Hart, Clinical Strategy Leader, AstraZeneca

Martin Fagan, VP Market Insight solutions, Infonetica

Nawab Qizilbash Director, Oxon Clinical Epidemiology Services and Consultant Geriatrician (Formerly, Director of Epidemiology and Evidence-Based Medicine, GSK)

John Parkinson, Director, GPRD

Dr Elliot Brown, Principal consultant and Managing Director, Elliot Brown Consulting

Dr Jenny Muller, Head of Affairs Clinical Research Drug Safety, German

Pharmaceutical Industry Association (BPI)

Dieter Konrad, Manager of Department Information Processing, Boehringer Ingelheim

Craig Hartford, Head of Safety and Risk Management Sandwich Site, Pfizer

Reinhard Fescharek

Chairman of the PtC Expert Working Group and Director Medical Global Drug Safety, Bayer Healthcare

Johann Prove, Global Head of Data Acquisition and Management, Bayer Healthcare

Dr. Lívia Stankovics Affiliate Head of Pharmacovigilance and Regulatory Medical Affairs , Sanofi-Aventis

Phil Berry, Head of Pharmacovigilance, Boots Healthcare

Phil Weatherill, Head of Pharmacovigilance, Ipsen

Yola Moride, Associate Professor, Faculty of Pharmacy University of Montreal

Barry Hardy InnovationWell Community of Practice Manager, Douglas Connect

Paula Marquez, Director of Clinical Safety, PharmaMar

Professor Saad Shakir MB ChB LRCP&S FRCP FFPM FISPE MRCGP, Director, Drug Safety Research Unit, Southampton , UK

Sidney Kahn, M.D. , President, Pharmacovigilance & Risk Management, Inc

Peter Elkin, M.D. , Professor of Medicine, Mayo Clinic

Jim Averback, President, Life Science Integration Partners

A Leander Fontaine , M.D., President, Pharmiceutics

Speaker Biographies

Below is a selection of speaker biographies

Dr Craig Hartford

Dr Craig Hartford graduated MB BCh, MSc Med and held full-time academic and research posts in the Faculty of Medicine in Johannesburg until 1998. Completing his PhD in respiratory medical devices, he was a clinical investigator for several Phase 2/3/4 cardiovascular studies 1990-1996, publishing many cardiovascular and respiratory research articles. Craig was awarded the IEEE Whitaker International Biomedical Engineering Prize in 1996 for his research into respiratory critical care medical devices and remains a University Honorary Research Associate. As a Pfizer Clinical Submissions Manager in April 1999, he applied  cardiovascular knowledge and expertise to supporting several successful European centralised and MRP approvals, and was a Sandwich Regulatory Project Leader. In November 1999 he took leadership of the combined Genito-Urinary and Sexual Health/Cardiovascular Therapeutic Areas in the Worldwide Regulatory Affairs Clinical Regulatory Submissions Group at Pfizer Sandwich. In 2001 he became Global CV Therapeutic Area Head in Clinical Regulatory Submissions, within the Clinical Safety and Risk Management organisation and held a dual-role as Sandwich Clinical Safety and Risk Management Site Head and Global Therapeutic Area Safety Head. In Pfizer Worldwide Development he currently manages the Risk Management Leaders for Pfizer Sandwich UK Development's Risk Management Strategy group, where he is also the Pfizer Safety and Risk Management Site Head.

Dieter Konrad

Dieter's background is Mathematics and Informatics. He started at Boehringer Ingelheim with Statistical Packages. First in the development of company specific software, later by supporting commercial available software used from laboratories to clinical trials. In 1996 he moved from efficacy to safety becoming responsible for research and development of one, but at most drug safety sites used, of Boehringer Ingelheim's home grown drug safety systems. Implementing ARISg as one global drug safety system (productive since November 2001) he took over the site liaison coordination in June 2000. He was actively involved as an expert in the various areas and   co-chair of the EudraVigilance Data Warehouse group established at the EMEA. He is involved in E2B and Signal Detection activities too.

Dr Elliot Brown

Dr.Brown worked as a family physician, then spent 10 years in senior positions in various pharmaceutical companies working in medical services and pharmacovigilance. He was a senior medical assessor for 5 years at the UK MHRA and was UK representative on the EMEA's CPMP Pharmacovigilance Working Party, the principal European regulatory body on drug safety. He was also EU representative on the ICH M1 (MedDRA) Expert Working Group, and until recently a member of the WHO Uppsala Monitoring Centre signal review panel and a founding member of the CIOMS working group on Standardised MedDRA Queries. He has spoken at and chaired numerous international conferences and published extensively on drug safety topics.

Dr.Brown is Managing Director of Elliot Brown Consulting, an international firm of consultants specialising in pharmacovigilance and risk management. He is a Senior Lecturer at the University of London 's School of Hygiene and Tropical Medicine, associate editor of the International Journal of Pharmaceutical Medicine and a member of the Editorial Board of the journal Drug Safety.

Dr Herve Laurent

Based on a double background - technical and medical –Dr Hervé Laurent started his carrier in 1976 at La Pitié-Salpetrière Hospital in Paris . During 17 years he was an investigator in Phase III, IIIb and IV studies and has built strong relationships with Pharmaceutical companies. Progressively, his interest in using new technologies and innovative processes for data collection for clinical trial management increased.

Dr Laurent founded and chaired BIOSTAT, which focused on the use of technology to collect naturalistic data in Phase IV settings in a cost-effective manner. Within BIOSTAT he designed and managed large European-wide clinical and epidemiological studies in a range of therapeutic areas.

Dr Laurent served as Vice-President and General Manager of PAREXEL from 1999-2004, and joined Quintiles in March 2004.

Dr Johann Pröve

•  Johann's background is Biology and he started his business life in 1980 at Bayer in clinical data management.

•  Between 1990 and 1994 he was Head of Data Management at Miles Inc (now Bayer Corp) in West Haven , Connecticut , USA .

•  In 1997, he took over the position of Head of Remote Data Entry Europe and Overseas.

•  December 1 st , 2000 he was appointed Head, Global Data Acquisition and Data Management at Bayer, in charge of all data management activities, incl. e.g. CRF design, EDC, data cleaning and coding.

Dr Nawab Qizilbash

Nawab Qizilbash, MBChB MRCP BSc MSc DPhil(Oxon.) is an epidemiologist, practicing consultant geriatrician and founder of Oxon Outcomes Ltd. His consultancy and contract research company specializes in ‘real world' outcomes: epidemiology, product safety, patient-reported outcomes, health economics, registries and European phase IV studies and trials. Each area draws on people with an international research record in the field.

Dr Qizilbash was formerly Director of Epidemiology at GlaxoSmithKline,    1997-2005, and formerly Honorary Consultant Physician and Honorary Senior Research Fellow, Radcliffe Infirmary, Oxford

University, where he worked with Professor Sir Richard Peto in epidemiology, phase IV trials and meta-analysis.

Paula Marquez

Paula Marquez joined PharmaMar, a new biotech company specialized in Oncology therapy (with marine organisms as a source of new anticancer agents; http://www.pharmamar.com )   in March 2002 as the Director of Clinical Safety Group and responsible for International Pharmacovigilance Group.

She was previously working as the European & Canada Director of Pharmacovigilance Team in Pfizer Inc., coordinating Safety Activities for 46 countries; Safety Manger in Pfizer Spain building up Spanish Pharmacovigilance Regulation in cooperation with Regulatory Agency.

In her current position as Director of Clinical Safety & Intl PhV Group in PharmaMar she is responsible to coordinate Safety activities from Preclinical phase to marketing through clinical development, with special emphasis in adverse events emerging form clinical trials management and the development of a new data base management system   in cooperation with PhMar partner Johson & Johnson.

Paula Marquez is also Pharmaceutical Medicine Professor in University Complutense in Madrid , and lectures extensively in drug safety matters in Academia, Regulatory and Pharmaceutical Industry Forums.

Dr Philip Weatherill

Dr Philip Weatherill is the Director, Global Pharmacovigilance, for the Ipsen Group, a role he has held since mid-2004.

Phil joined Porton Developments Limited in November 1987 as a Senior Scientist working on the assessment of viability of the new projects.   In 1999 he became Manager of Drug Safety with responsibility for the pre-clinical development projects for the Company.   The role expanded into the area of Pharmacovigilance.

In the mid 1990's Porton Developments Limited became Ipsen Limited and part of the Beaufour Ipsen Group.   This led to increased opportunities and, following a restructuring of the central pharmacovigilance department, he became responsible for pharmacovigilance activities in the English speaking world ( UK , North America, Australia , New Zealand , South Africa etc) and Japan .

Phil graduated in 1977 from Dundee University with an honours degree in Biochemistry and in 1980 with a PhD in the area of biochemical pharmacology.

Dr Reinhard Fescharek

Dr. Fescharek started his medical career as hospital physician in France 1981. From 1985-1987 he served as senior consultant in development projects in Sub-Sahelian Africa before he joined the pharmacovigilance department of Behring Werke, Germany, later Chiron-Behring Vaccines. He specialized in drug safety of vaccines and immunoglobulins and other blood derivatives and cytokines. In 1998 he joined Sankyo Pharma in Munich and reorganized the European Drug Safety structure. As Head of Medical and Regulatory Affairs Europe he expanded his responsibilities including pharmacovigilance, clinical development and Drug Regulatory Affairs. In 2001 he became Head of Global Drug Safety for Sankyo Co. Since November 2003 he is Head of Medicine in Global Drug Safety at Bayer HealthCare AG, Wuppertal .

Dr. Fescharek was involved in the MedDRA project since the beginning and has later on participated in both ICH expert working groups developing the Points to Consider documents. Since June 2003 he is chairing the Point to Consider Group at ICH.

Dr. Fescharek is author of many publications on vaccine safety, drug safety and MedDRA with special emphasis on methodological aspects.

Professor Saad Shakir

Saad Shakir qualified in Medicine in 1976 and has worked as a physician ever since.   He has been working in pharmacovigilance & pharmacoepidemiology for more than a decade, initially at the Medicines Control Agency (MCA) in the UK then in international pharmaceutical industry. He was appointed as the Director of the Drug Safety Research Unit in Southampton in 1999.   He there leads a research team with an active programme for monitoring and studying the safety of medicines.   Throughout his career, he has been involved in initiatives to promote and develop pharmacovigilance and pharmacoepidemiology, published extensively on this and is a member of the editorial boards of journals of Pharmacoepidemiology and Drug Safety.

Dr Yola Moride

Dr. Yola Moride has received an MSc degree in genetics, and a PhD in epidemiology and biostatistics from McGill University in Montreal , Canada . She has also trained as a post-doctorate fellow at the Bordeaux Pharmacovigilance Centre. Yola has over 15 years of experience in the conduct of post-marketing drug safety and utilization studies. From 1994 to 2001, she held full-time academic appointments at McGill University and Université de Montréal.   Since 2001, she has been an independent consultant working with the pharmaceutical industry and regulatory authorities both in Europe and North America, while maintaining academic appointments at McGill University , Université de Montréal, and University of Bordeaux .    In 2002, she was also Visiting Professor in the Dept of Pharmacoepidemiology at Utrecht University in the Netherlands . Throughout her career, Yola has obtained numerous grants and personal research career awards. She has served on the Board of Directors of the International Society for Pharmacoepidemiology and of the Canadian Association for Population Therapeutics. In addition to conducting her own studies, she serves on numerous scientific committees of industry-sponsored Phase IV and post-marketing risk management studies.

High quality speakers include: