Date: 18th – 19th November 2014 | Location: Hilton London Euston Hotel London | Category: Pharma
"Effectively managing and identify potential risks regarding drug safety"
Recunnect’s Pharmacovigilance 2014 Conference: This conference will address some major issues regarding drug safety, including identifying and effectively managing potential risks. There are current and key challenges and complexities in Pharmacovigilance and risk management throughout the product lifecycle. Companies still have to learn about how to tackle these.
The conference will also have a discussion on the experience of the new European Union regulations and if harmonisation is a vision of the future. Taking a look at the digital communication nowadays, the use of social media for Pharmacovigilance will also be highlighted. What has changed? What are the current and upcoming trends within the Pharma sector and target audiences? With the use of internet, smartphones, tablets and other non-classic means of data collection and communication, innovative ways of creating new possibilities for real-time and rapid analysis of drug-use.
Pharmacovigilance will be able to look at effectiveness, safety issues, adverse events and create some new perspectives as well as gaining lots of other useful information about Risk Management and analysis on drug safety.
- Design risk-benefit analysis tools to enhance internal risk evaluation and mitigation strategies.
- Review the current European Union regulations.
- Examine global drug safety; Pharmacovigilance strategies.
- Understand the use of social media in Pharmacovigilance
- Learn about effective signal detection strategies
- Get insight into safety of Medical Devices
Why should you attend?
There are still major issues to be addressed regarding drug safety, including identifying and effectively managing potential risks and ensuring a balanced benefit and risk ratio. There are current and key challenges and complexities in Pharmacovigilance and risk management throughout the product lifecycle which companies still have to learn about.
Who should attend?
VPs, Directors, Heads, Managers, Scientific, Advisors, Consultants of:
- Pharmacogenomics, Drug/Product Safety
- Drug Development, Information and Clinical Data Management
- Clinical Pharmacology
- Clinical Safety
- Periodical safety update Reports
- Risk Management, Research & Development
- Quality Assurance
- Patient Safety
- Signal Detection
- Safety Surveillance
- Outcomes Research
- Data Analysis
- Medical Affairs
- Regulatory Affairs and Compliance
- Information technology
- Sales and Marketing
- Software Providers
Pharmacovigilance Manager and Head of Chugai Pharma Marketing
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
Senior Director and Clinical Safety and Risk Management
Sandip qualified in Medicine from the University of Calcutta, India in 1987 and underwent post-graduate training in General Surgery in India, Ireland and the UK. After obtaining the FRCS (Fellowship of the Royal College of Surgeons) he specialised in Cardiothoracic Surgery in Dublin, Ireland and worked as a Consultant Cardiothoracic Surgeon in India and Sri Lanka and as a Senior Registrar in Oxford, UK. Immediately prior to joining Pfizer, Sandip worked as part of the Medical Affairs team at PPD (a Contract Research Organisation), where his responsibilities included Medical monitoring for clinical trials and provision of Medical support to the business development team.
Sandip joined Pfizer Clinical Safety and Risk Management in June 2004 and has provided Safety and Risk Management support to numerous compounds in development and post-approval. Sandip is currently the Disease Area Cluster Lead for Cardiovascular, Metabolic and Haematology products in Safety Surveillance and Risk Management at Pfizer.
In his spare time, Sandip enjoys books and movies (particularly literary novels and world cinema) and he is also an avid follower of sports. more
Director of Regulatory, PHV and Medical
Actavis UK Ltd
Jackie Roberts is Director of Regulatory, Pharmacovigilance and Medical at Actavis UK Ltd. Jackie has a PhD from Imperial College and an MBA from Warwick. Previous work includes the MHRA, NHS, industry and consultancy. Currently Jackie is responsible for a diverse local portfolio and also belongs to the Global Medical Communications Board and Global Ethics and Compliance function. more
Director & QPPV
Deputy EU QPPV, Senior Safety Scientist Global Safety & Epidemiology
Rachel has worked in the pharmaceutical industry of over 22 years and in Pharmacovigilance for 17. She obtained a Post Graduate Diploma in Pharmacovigilance from the University of Hatfield in 2000.
Rachel is currently Deputy EU QPPV at Allergan where she has responsibility, amongst other things, for the PSMF. more
Dr Sumit Munjal
MD Global Pharmacovigilance
Dr Sumit Munjal, worked as a medical doctor in India and gained Neurosciences clinical experience in the National Health Service (NHS), UK. In 2007, he completed his research Masters’ degree in Epidemiology from London School of Hygiene & Tropical Medicine (LSHTM).
Subsequently, he worked in the field of pharmacoepidemiology as a Clinical Research Fellow at the Drug Safety Research Unit (DSRU), Southampton. He further worked as a Medical Assessor in Pharmacovigilance at the Medicines & Healthcare products Regulatory Agency (MHRA), UK and was involved in the decision-making of some important EU and international regulatory drug safety issues.
Since 2010, he has worked as a Consultant in the area of Oncology unmet medical need and has worked within Global Medical Safety department of pharmaceutical companies such as Janssen Cilag Ltd, Johnson & Johnson and Takeda: Millennium, The Oncology Company. He is currently working as a Medical Director, Global Pharmacovigilance with Takeda: Nycomed and is based in Central London, UK. more
Alistair J. Coates
Eudra Vigilance Consultants Ltd
Alistair J. Coates his career within the pharmaceutical industry spans over two decades, where he has been involved with pre-marketing Clinical Drug Safety and post-marketing Pharmacovigilance.
With a first degree in pharmacology and a subsequent qualification in Pharmacovigilance, his consultancy currently has clients from smaller start-ups to large pharmaceutical companies. more
Statistician, Epidemiologist Clinical Practice Research Datalink
Arlene Gallagher is an Epidemiologist with postgraduate training in Statistics. Arlene joined the CPRD (formally GPRD) Research Team at the MHRA in 2004. She has considerable experience in analysing large healthcare databases including the CPRD GOLD, Hospital Episode Statistics (HES) and the ONS mortality data, and has been the principal investigator for a wide range of epidemiological and safety studies. Arlene has presented at various large scientific conferences as well as being an invited speaker at various meetings in the field of pharmacoepidemiological research using observational databases. She has an MSc in Medical Statistics and is currently working on her PhD in pharmacoepidemiology. more
Doris Irene Stenver
Chief Medical Officer
Danish Health and Medicines Authority
She joined the Danish regulatory authorities 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 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. She is external lecturer at Copenhagen University, covering pharmacovigilance and pharmaceutical policy and decision-making. In 2004 – 2008 she was a member of DIA Advisory Council for Europe. more
Strategic Global Consultant
Life Sciences Solutions, SDL
Chris McCourt is a Global Consultant in SDL’s Life Sciences Solutions division. SDL is a top three provider of language, technology and business intelligence solutions to international pharmaceutical and medical device companies and contract research organisations. more
Robert L. Bencher
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
Clinical Epidemiologist & Head, OXON Epidemiology & Honorary Senior Lecturer in Pharmacoepidemiology, London School of Hygiene & Tropical Medicine
Nawab is a clinical epidemiologist (still sees patients), co-author of 5 Lancet articles and Head of OXON, a CRO with ‘real world’ centres for secondary data in London and field studies in Madrid, conducting pan-European PASS and risk minimisation studies.
As a member of the ENCePP Steering Group he has links with EMA and national regulators and leading EU Pharmacoepidemiologists. more
Sidley Austin LLP
Professor Salvatore is a senior counsel in Sidley’s Brussels office and a member of the firm’s EU Life Sciences Regulatory team. His practice focuses on a broad array of regulatory and compliance matters. He provides strategic legal counselling on the EU’s legal process regulating all aspects of the pharmaceutical industry, including enforcement and data protection issues. He has extensive experience on all aspects of EU policies, particularly pharmaceutical regulation, public procurement and public utilities. He is an experienced litigator and has represented public authorities, companies and individuals before the European Court of Justice in Luxembourg in landmark EU law disputes. more
Mark Drinkwater is director and co-founder of Pi2 Solutions, which was recently acquired by ProQuest. Pi2 Solutions provides cutting-edge product literature databases and workflow solutions to the pharmaceutical industry, and Mark has led Pi2’s initiatives in the drug safety discipline. A chemist by training, Mark has worked for several pharmaceutical information companies, and has advised global organizations through to small biotechs. Mark obtained his BSc (Hons) in Applied Chemistry from De Montford University in Leicester, UK. more
Prof Saad Shakir
Drug Safety Research Unit
Saad Shakir MB ChB LRCP&S FRCP FFPM FISPE MRCGP qualified in Medicine in 1976 and worked in hospital medicine for eleven years before moving to general practice. He has been working in pharmacovigilance & pharmacoepidemiology for more than a decade, initially at the Medicines Control Agency (MCA) in the UK then in the international pharmaceutical industry.
He was appointed as the Director of the Drug Safety Research Unit (DSRU) in Southampton in 1999. The DSRU is an academic Unit associated with the University of Portsmouth. At the DSRU he leads a research team with an active programme for monitoring and studying the safety of medicines. Saad Shakir is a Fellow of the Royal Colleges of Physicians in Glasgow, Edinburgh and London, a Fellow of the Faculty of Pharmaceutical Medicine and a Member of the Royal College of General Practitioners in the UK. He continues to practice clinical medicine part-time.
He has worked and advised on many drug safety issues including product withdrawals and major safety hazards. He is an author of many publications in scientific journals on pharmacovigilance and pharmacoepidemiology and is a member of the editorial board of the journals of Pharmacoepidemiology and Drug Safety. Saad Shakir has led, co-ordinated and participated in many postgraduate educational and training programmes. He supervises postgraduate students for higher degrees and has been involved with a number of international initiatives to promote and develop pharmacovigilance and pharmacoepidemiology. more
Application Support Specialist
Benjamin Beier, Application Support Specialist, background in customer relationship management, troubleshooting, project management and technical consulting. more
Principal Consultant in risk management strategy and implementation. 15 years pharmaceutical industry consulting experience. SafetyGauge™ Product Manager. Designed and implemented many risk minimisation programmes. Leads deployment of complex informatics tool for patient access schemes, real-time effectiveness evaluations and PASS studies more
Medical News Today is the largest independent medical and health news site on the web – with over 8,000,000 monthly unique users it is ranked number one for medical news on all major search engines. Medical News Today is used by pharmaceutical, biotech and health organizations, advertising agencies, PR companies and vertical ad networks to deliver targeted disease/ condition and general health campaigns. For more information contact email@example.com or visit www.medicalnewstoday.com. more
Bentham Science Publishers is a major STM journal publisher of 116 titles and 200 plus open access journals and print/online book series (Bentham eBooks). Bentham Science answers the information needs of the pharmaceutical and biomedical research community. Leading journals include Current Drug Metabolism (Impact Factor 5.113) and Current Medicinal Chemistry (Impact Factor 4.859): • FREE online journals and information: www.benthamscience.com • Subscribe, Consortia, discounted global licenses and trials: firstname.lastname@example.org • To know more about our publications please visit www.benthamscience.com. more
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ProQuest Dialog and Pi2 offer a market-leading combination of pharmaceutical and biomedical databases, advanced alerting systems, and literature screening tools. With decades of experience in research and development, pharmacovigilance, competitive intelligence, and other biopharmaceutical functions, you can trust ProQuest Dialog and Pi2 to meet your information needs. more
Eudravigilance Consultants Ltd is an independent consultancy service to the pharmaceutical and biotechnology industries for Pharmacovigilance, run on “virtual” lines. With over twenty one year’s experience in pre-clinical pharmacology, pre-marketing clinical safety & clinical data management, post-marketing pharmacovigilance & medical device vigilance, we provide expertise for companies to develop measurable improvements in performance. more
PVmonitoring.net focus on searching adverse drug reaction (ADR) mentions in specialized medical and pharmaceutical printed media. PVmonitoring.net clients are provided with strong instruments of monitoring, collecting and analyzing information. Reports are stored in the personal clients account where they’re able to quickly access them to view adverse drug reaction (ADR) case reports, drug safety studies and regulatory news affecting the market. more
Accounts House is a proactive firm of Chartered Certified Accountants specialise in helping businesses with all their tax and accounting needs. We have a team of qualified and part-qualified Accountants with extensive experience in tax and accountancy. we can offer an outstanding value service by using the latest technology to communicate with you. more