News : Reports
BMA report about pharmacovigilance
Report : pdf file
http://www.bma.org/ap.nsf/Content/AdverseDrugReactions
ICPM Seoul 2006
Ken Hartigan-Go participated in the 14 th International Conference on Pharmaceutical Medicine in Seoul from 4-6 September 2006 on behalf of ISoP.
This conference had a theme on Beyond the Horizon and was jointly organized by the International Federation of Associations of Pharmaceutical Physicians and the Korean society of Pharmaceutical Medicine. There are some initiatives to position pharmaceutical medicine as a distinct discipline and at the moment some institutional curriculum for education and training is developing this science further. The following were focused areas of the conference: clinical trials, importance of proactive pharmacovigilance, ethics in biomedical research and pharmaceutical business practices, improving access to medicines, new initiatives in training, new drug development such as nanoprobe technology, and pharmacogenomics and their regulatory perspectives.
With Brian Edwards as co-aut ho r, Ken Hartigan Go spoke on pharmacovigilance planning in risk management and the need to ensure proper use of medicines. The session examined ho w approaches to integrate safety into corporate social responsibility can help improve patient safety. There are worrying concerns here in Asia that pharmaceutical risk management planning might be regarded as solely a western concept and a compliance requirement based on territorial regulations. One must think of managing the risk of medicines more ho listically in a way. It is necessary to consider that in Asia , for instance, resource is scarce, ethical interpretation differs and certain risks are disproportionately higher compared to the West, such as realities of counterfeit and sub-quality products, controversies surrounding patient consent. Because undertaking pharmacovigilance planning goes beyond the traditional business approach to product stewardship, one needs an approach centered on the patients and on health professionals. PV is all about helping ensure the right patient gets the right dose of medicine in a proper manner, moving away from simply searching for evidence of harm to actively demonstrating safety, so as to create an acceptable balance of benefit and risks for medicines.
Report on joint ISoP / ISPE meeting 2004
A short report is downloadable here (Adobe pdf) on a joint workshop at the ISPE meeting in Bordeaux, August 2004, entitled 'Breaking out of the Bubble: what have we learnt about risk communication?'
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