Drug & Patient Safety Workshop on Risk Management, Labeling Decision-Making, Personalized Medicine,

Venue: Oxford University

Location: Oxford, United Kingdom

Event Date/Time: Jul 03, 2006 End Date/Time: Jul 05, 2006
Early Registration Date: Mar 31, 2006
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Risk & Knowledge Management in Drug Safety

We are holding a 3 Day InnovationWell Drug & Patient Safety 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

Monday 3 July 2006

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.

More Information at …. http://innovationwell.net/COMTY_shakiroxford/

Tuesday 4 July 2006

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.

More Information at …. http://innovationwell.net/COMTY_fontaineoxford/

Wednesday 5 July 2006

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.

More Information at …. http://innovationwell.net/COMTY_elkinoxford/


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!


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 community of practice group and access to InnovationWell meeting proceedings.


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: enquiries [at] douglasconnect.com, Tel: +41 61 851 0170


Mansfield Road
United Kingdom

Additional Information

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!