We are holding a 3 Day InnovationWell Workshop on the 3-5 July 2006 at Oxford University, Oxford, UK. These interactive pragmatic workshops will be led by leading medical faculty instructors: Saad Shakir, Director, Drug Safety Research Unit, UK, A. Leander Fontaine, President, pharmiceutics and Peter Elkin, Professor of Medicine, Mayo Clinic who will work through and discuss issues and complex case-studies.
Topics to be covered include: Risk Management Planning, Integrating Clinical Development & Pharmacovigilance Planning, Communication of Drug Safety Issues, Safety Evaluation and Outcomes, Managing Spontaneous Reporting, Responding to new US and EU Labeling Regulations & Guidelines, Proactive Drug Safety Knowledge Management, Decision Support for Research and Practice of Medicine, and Latest Advances in Pharmacogenomics & Personalised Medicine.
These workshops are aimed to bring leading best practice and issue discussion to practitioners in the healthcare industry working in the increasingly integrated cross-functional area of proactive drug and patient safety management. Workshop groups will work through and discuss complex issues highlighted by detailed case studies presented by instructors.
Healthcare providers, program managers, clinical development management, safety & pharmacovigilance experts, product managers, clinical and regulatory affairs, and post-marketing support will all take-away key nuggets of understanding in this fast-evolving field and will have ample opportunity to share and discuss their different perspectives.
More details on the workshops can be found on the InnovationWell website at http://innovationwell.net/COMTY_dstraining
Further information on the Program, Accommodation and Registration follow here...
Program
Monday July 3
Practical Strategies for Risk Characterisation, Assessment and Management of Medicinal Products
Led by Professor Saad Shakir, Director, Drug Safety Research Unit, UK
No effective medicine is without risk. Most of these risks are known (though not always fully defined) when a product is launched; however, some of the risks are unknown and are discovered during clinical use.
Effective use of medicines requires balancing the benefits and risks. Obviously, risks which are incompletely defined at the time of the launch need to be better characterised and quantified. This requires conducting appropriate studies (observational and experimental).
All the information about the risk/benefit balance is of no benefit to patients unless it results in practical actions at prescriber and patient levels to optimise the risk/benefit balance. In the last few years immense interest from regulatory authorities, the pharmaceutical industry and academia has focused on improving the risk/benefit balance. Various strategies have been adopted to optimise the risk/benefit of these medicines.
This workshop will provide awareness of the methods to characterise risk, assess risk/benefit balance and implement practical strategies for risk management. Case studies will be used.
About Saad Shakir
Professor 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 and 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 was elected recently as a Fellow of the International Society of Pharmacoepidemiology. He is a Member of the Royal College of General Practitioners in the UK and 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 boards 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.
Tuesday July 4
Safety Labeling Decision-Making and Regulatory Implementation
Led by A Leander Fontaine, President, Pharmiceutics
Based on the outcome of the case study presented by Saad Shakir on day one, participants will form “labeling committees” and decide which information to provide in product labeling (prescribing information), design a global regulatory implementation strategy and a global publication strategy. The case study will also include negotiation scenarios with regulatory authorities. It will be accompanied by a series of lectures by Leander Fontaine, who will discuss the principles of safety labeling decision making and a provide a comparative review of safety labeling regulations, guidelines and regulatory expectations.
About A Leander Fontaine
A Leander Fontaine is President of Pharmiceutics LLC, a Pennsylvania-based company which offers labeling and regulatory consulting, expert services and training.
Before founding Pharmiceutics in March 2005, he was Vice President and Head of Global Labeling Division and Vice President, International Labeling Liaison, Wyeth, USA. He started his career in global labeling in 1991 and has served as head of global labeling functions for Hoechst Marion Roussel (USA) and Hoechst (Germany). He has also held positions in clinical development with Behringwerke (Germany).
Before joining the pharmaceutical industry, he worked in internal medicine (German Army Hospital Ulm, Germany) as well as in anesthesiology, intensive care and emergency medicine (University Hospital Ulm, Germany). He received his medical degree in 1979 from Saarland University, Germany, and received his doctoral degree in 1985 from University of Ulm, Germany.
Wednesday July 5
Latest Advances in Pharmacogenomics, Personalised Medicine and Decision Support for Research and Practice of Medicine
Led by Professor Peter Elkin, Mayo Clinic
This workshop will define the imperative toward personalized medicine and show how our current methods of practice are transitioning toward a new more specific and more knowledge based practice methodology. Specifically we will discuss: What is Personalized Medicine? How is it different from how we practice today? What are the implications for drug safety and monitoring? How can participants begin to incorporate personalized diagnosis and treatment into their practices or their organization’s method of practice? We will define methods for knowledge based practice of medicine and learners will be taught how to use clinical decision support in their practice setting. Further they will see how to use logic to build computable rules to drive clinical decision support. Lastly participants will get a hands on demonstration of clinical decision support for patient safety (drug safety), quality reporting, point-of-care just-in-time case-based education. Users will have direct interaction with faculty and will be able to present their own organizational challenges and engage the faculty and participants to see if suggested solutions can be brought to light.
About Peter Elkin
Dr. Peter L. Elkin is a Professor of Medicine at the Mayo Clinic College of Medicine. He received his Bachelor of Science from Union College and his M.D. from New York Medical College. He did his Internal Medicine residency at the Lahey Clinic and his NIH/NLM sponsored fellowship in Medical Informatics at Harvard Medical School and the Massachusetts General Hospital. Dr. Elkin has been working in Biomedical Informatics since 1981 and has been actively researching health data representation since 1987. Dr. Elkin directs a laboratory of Biomedical Informatics within the Department of Medicine at Mayo. Dr. Elkin currently is the Chair of ASTM E31.01, the subcommittee focused on Controlled Health Vocabularies. Dr. Elkin is the Chair of the OASIS International Healthcare Continuum (IHC) that focuses on creating and promoting standards for global health information.
Dr. Peter L. Elkin is the primary author of the American National Standards Institute's (ANSI) national standard on Quality Indicators for Controlled Health Vocabularies ASTM E2087, which has also been approved by ISO TC 215 as a Technical Specification (TS17117). Dr. Elkin is the principal author on the draft ISO TC 215 Technical Specification on Health Indicators: Definitions, Relationships and Attributes. Dr. Elkin chairs ASTM E31.29, which is currently developing national standards for Bioinformatics and E31.01 on Controlled Health Terminologies. Dr. Elkin is a co-chair of the HL7 Clinical Genomics Special Interest Group. Dr. Elkin is the index recipient of the Homer R. Warner award for outstanding contribution to the field of Medical Informatics. He is the 2005 recipient of the Mayo Clinic's Department of Medicine's Laureate Award in recognition and appreciation of his dedication to patient care, educational excellence and high standards of personal integrity.
Accomodation:
We have available a limited number of rooms in college in Oxford and will offer these rooms at no additional cost on a first-come first-served basis to registrants registering during the early registration period. Early Registration period runs through 31 March 2006 and includes 3 nights bed & breakfast accommodation in college. Please book early as places are limited!
Registration:
The registration fee of £1500 includes attendance at the three day workshop and provision of all supporting materials to use and take-home from the workshop. The fee also includes a lunch each day in addition to drinks and snacks for 2 breaks per day.
Registration at the workshop also includes a one year annual membership to InnovationWell (value £220) including membership of the drug safety community of practice group and access to InnovationWell drug safety meeting proceedings.
Location:
The workshops will take place at the Chemistry Research Laboratory, Oxford University, Oxford, UK.
This new state of the art facility provides 17,000 sq meters of research space to 400 researchers and at a cost of more than £60M is the largest capital project undertaken by Oxford University to date.
A virtual tour of the facility is available at: http://www.chem.ox.ac.uk/oxfordtour/crl/
For further information and questions on these workshops & training program and registration, please contact: Barry Hardy, eMail: barry.hardy [at] douglasconnect.com, Tel: +41 61 851 0170
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