Head of Pharmacoepidemiology
Head of Pharmacoepidemiology
Paul is Head of pharmacoepidemiology at Takeda, where he and his team have global responsibility for all Post Approval Safety Studies at Takeda. He holds a DPhil from Oxford in Epidemiology and has worked in the pharmaceutical industry for 20 years. He has been a member of several CIOMS working groups, and has wide experience in pharmacovigilance, including as a QPPV. more
Project Excellence Manager (Social Media)
Drug Safety & Epidemiology
Novartis Pharma GmbH
I am working in the pharmaceutical industry in positions of increasing responsibility for more than ten years. In my former position at Cephalon GmbH, Munich, Germany I acted as deputy of the German Qualified Person of Pharmacovigilance (Stufenplanbeauftrager) and as deputy of the European Qualified Person of Pharmacovigilance. I am with Novartis Pharma GmbH since August 2011 where I acted as Local RMP Manager for two years. In my current position as Drug Safety Project Excellence Manager I am responsible for implementation of Risk Management Plans, management of market research and patient support programs as well as coordination of Social Media activities. I am holding a degree in pharmacy from the university of Erlangen-Nuremberg, Germany and received a PhD for research on liver injury that was supported by a grant of the German Research Foundation. more
Head Global Drug Safety Regions
Heike is a registered physician, holds a specialist registration in internal medicine, diplomas in public health, epidemiology, tropical medicine and an MBA. After more than 10 years in university hospitals, she worked for 14 years in the pharmaceutical industry (Johnson & Johnson, Gruenenthal, Merck) in global leadership positions. more
Associate Safety Risk Lead(ASRL), Safety Surveillance & Risk Management
Karina is a Senior Manager, Associate Safety Risk Lead in Safety Surveillance and Risk Management in World Wide Safety Strategy at Pfizer. Karina has a strong background of research, project management, and process redesign as well as leadership in project teams. Her current role involves performing proactive Safety Surveillance and Risk Management to effect product safety signal detection, risk assessment and safety risk minimization. Within Safety, she works in the Generics group managing products across a diverse number of disease areas. Karina joined Pfizer as a Process Analyst supporting Oncology products and process improvements. Prior to joining the company, Karina worked at Imperial College London where she obtained her PhD in infectious diseases and immunology. Her post-doctoral work involved undertaking three clinical studies, two of which were based in Ethiopia investigating leishmaniasis in collaboration with the London School of Hygiene and Tropical Medicine. more
Director, Deputy EU QPPV Global Pharmacovigilance
Safety Medical Director, Oncology
Dr. György Zörényi has been with AstraZeneca for 19 years. As a Safety Medical Director he provides medical oversight for safety strategies of around 12 oncology projects. He is a Specialist of Pharmaceutical Medicine and a Fellow of the Faculty of Pharmaceutical Medicine. more
Global Pharmacovigilance Manager
Omega Pharma, Belgium
Over 18 years in Pharmaceuticals Industry (since 1996) and National Competent Authority. International expertise: EU and non-EU countries.
My responsibilities covered all aspects of the medicinal product, from sales and medical marketing up to Pharmacovigilance and Regulatory affairs.
The focus of my work has been full support and management on:
– Pharmacovigilance / Drug safety
– Quality and Regulatory compliance
– Cross-functional activities
– Medical data support
– Medical affairs, Medical information communication
– Advertising of medicinal products
Languages: English, Italian, Hungarian, German, French, Romanian. more
VP International GPV&E and EU QPPV
Veronica Fjellström has a Degree of Master of Medical Science from Uppsala University, Sweden. She is currently employed as a deputy EU‑QPPV at the generic pharmaceutical company, Bluefish Pharmaceuticals.
Veronica previous employment includes a position as a Head of Pharmacovigilance at a Clinical Research Organisation where she was responsible for the pre‑ and post- authorisation pharmacovigilance activities. During that period, she was also appointed deputy EU-QPPV for two pharmaceutical companies.
During her years in the consultancy business she has gained valuable knowledge of different pharmacovigilance systems at Headquarter level among various pharmaceutical companies. She has valuable insights from audits and inspections by national competent authority. more
Senior Pharmaceutical Assessor
Kurdistan Regional Government-Iraq
I’m a trained pharmacist and pharmaceutical scientist. I’m a trained pharmacist and pharmaceutical scientist. I started my career as a clinical pharmacist for a couple of years and then as pharmaceutical assessor for the Kurdistan Regional Government-Iraq. My particular area of interest is investigating the influence of temperature & humidity on stability and quality of pharmaceuticals when stored outside guidelines and specifications. In addition, designing, developing and validating novel techniques for detection of counterfeit and fake medicines. Our work has been instrumental in developing an anti-counterfeit medicines programme in Iraq, which at the end of 2012 had successfully seized 400 tonnes of counterfeit medicines of major therapeutic classes that were previously rife in Iraq’s markets. As a result of my work I received a number of internationally recognised awards; most recently The Leadership in Pharmacy Award from The Royal Pharmaceutical Society. more
Senior Pharmacovigilance Manager and
Head of Chugai Pharma Europe Pharmacovigilance Office
Chugai Pharma UK Ltd
Dr. Dammika Peiris is a Pharmacovigilance scientist and manager. She is currently the head of the European Pharmacovigilance team in Chugai Pharma Marketing Office. She is passionate about individual safety case report (ISCR) quality and compliance. Before she gained her Pharmacovigilance experience from the Global top Pharma companies, she worked as a leading research scientist in atherosclerosis/metabolic diseases and reproductive biochemistry research group, involved with biologic drug development. more
Vice President GxP Quality Assurance, Compliance and Training
He has over 25 years’ track record in the pharmaceutical industry. For some time, he was the Assistant Editor for 11 Medical journals. He contributed further to these disciplines by writing “The Pharmaceutical Medicine Dictionary” and “The Dictionary of Pharmacovigilance”. He is currently writing his 3rd book, Dictionary of Clinical & Pharmaceutical Development.
Amer is a frequently invited speaker at international congresses: has both presented & chaired at over 82 international congresses, universities, as well as the WHO.
Amer is currently the Vice President GxP Quality Assurance, Compliance and Training at Karyopharm. Concurrently, he is also the Managing Director of GxP Compliance & Training Partners (GCTP) consulting to Pharma companies.
His previous positions include: Director, Global Head of Quality Assurance at Merck Serono, Global Head of GxP QA at Arpida, Senior International Clinical Quality Assurance Audit Manager at Novartis and he was the first Pharmacovigilance Compliance Officer of the MHRA. more
Director – Regulatory, PHV and Medical
Jackie Roberts is Executive Director for Regulatory, Pharmacovigilance and Medical at Actavis for the UK, Ireland and South East Europe. By background she is a PhD pharmacologist with an MBA from Warwick Business School and has previous experience as a QPPV and as a scientific assessor at the MHRA. more
Robert Bencher, a Director for Myriad RBM, began his career as a scientist at Abbott Laboratories in 1983 and was involved in the development and ultimate FDA approval of the first commercially available HIV blood test. He has since held a number of sales, marketing, and business development roles with several companies including Johnson & Johnson, Pall Life Sciences, Chiron, and MetriGenix. Most recently, Rob was involved with the commercialisation of the bDNA gene expression platform and a flow-thru chip technology developed at the Oakridge National Laboratories. Rob holds a Chemistry degree from Michigan State University (1983) and a MBA in Marketing & Finance from Loyola University of Chicago (1987). more
Healthcare Data (Former Director CPRD, MHRA)
John Parkinson is an independent consultant having retired as Director of the Clinical Practice Research Datalink (CPRD). Between 2011 and 2014 he was the Director of the CPRD and also sat on the MHRA Executive Committee. He has a wide knowledge of Pharmacovigilance and Pharmacopeidemiology.
He is acting as a Consultant to NICOR, the cardiovascular audit datasets, to maximise the use of such data for purposes other than clinical audit- for instance drug and device safety. He is also acting to help ensure that hospital drug data, as available from IMSHealth, can also be used in drug safety work. more
IPM Private Sector – Senior Manager
World Customs Organization
Since 2015, Bob Peeters joined the World Customs Organisation (WCO) IPM Private Sector team as the Senior Manager. The WCO is the only intergovernmental organization exclusively focused on customs issues and is composed of 180 countries, representing 98% of the world trade.
Bob is responsible for the promotion of the IPM Tool amongst the Private Sector with his global team. He is also involved in the expansion of the IPM Connected programme, which mainly focuses on collaborating with authentication and track & trace technologies.
Prior to the WCO, Bob was working in the EMEA and APAC IT and telecom industry, focusing amongst others on security and integrity aspects of national and global networks more
Drug Safety Research Unit
Saad Shakir is Director of the Drug Safety Research Unit (DSRU) in Southampton. The DSRU is an academic Unit associated with the University of Portsmouth. Here he leads a research team with an active programme for monitoring and studying the safety of medicines. more
Bird & Bird
Sally is is a Partner in the IP and Life Sciecnes groups at Bird & bird in Loondon. She provides a full range of intellectual property commercial advice and support to her clients, including licensing, partnering and exploitation agreements, research, development and marketing collaborations. She also frequently advises clients on regulatory and ‘freedom to operate’ matters, and manages significant due diligence matters. As a transactional intellectual property lawyer, she provides advice in relation to the protection and exploitation of a full range of IP rights, both in stand alone transactions and as part of an acquisition, divestment or investment activity.
Before joining us in 2006, Sally was head of IP and Life Sciences at Eversheds, and prior to that she spent 11 years working in-house firstly as senior legal advisor at ICI/Zeneca and latterly as Legal Director of Novartis UK. This in-house experience gave her significant insight into the need to give pragmatic and commercial advice. more
Oleksandr is a medical doctor with a license to practice in the UK, holds a General MBA diploma from KMBS. After specialization and practicing Orthopaedics and Trauma, he joined the industry more than 12 years ago. Since then, he gained experience in clinical, safety and people management with innovative pharmaceutical companies and CROs (Roche, AstraZeneca, Takeda, Servier, PRA etc.) and contributed to various cross-functional initiatives, including innovation management, continuous improvement and organisational restructuring. more
Director & QPPV
Dr. Pipasha Biswas qualified in Internal Medicine/Cardiology and spent 5 years in clinical practice. She then moved to Pharmacovigilance working in increasing roles for the last 20 years at various organisations including Drug Safety Research Unit, Wyeth Europe, GSK and Amgen. Currently she is Executive Director & QPPV at Symogen, which is an internal service provider to pharmaceutical companies in the field of pharmacovigilance, pharmacoepidemiology, medical writing and regulatory affairs. She is the Chairperson for SIN for Pharmacovigilance and Director of CPD at The Faculty of Pharmaceutical Medicine. more
As a qualified doctor, Ennis worked in hospital medicine before joining the pharmaceutical industry, working in clinical development and the MCA in pharmacovigilance. She specialised in early development at J&J Pharma before becoming VP and EU QPPV. Ennis joined TranScrip in 2015 as a Senior Partner. more
Suzanna Gamwell is part of Creation Healthcare, a research consultancy that specialises in understanding online conversations between healthcare professionals. In her role as Client Advocate she works closely with client teams to understand their vision, priorities and needs, and inspires the team at Creation Healthcare to deliver the best possible customer experience and research outputs.
Before joining Creation Healthcare, Suzanna spent seven years in communications and engagement roles in the public sector, overseeing campaigns and behaviour change initiatives in the UK and Europe. more