Reporting Drug Safety Research
Research, delivery and publication strategies for drug safety reporting
July 11 – 12, 2005 Arlington, VA
Visit the conference website for more information and to register.
The pharmaceutical industry is on the brink of a tremendous change.
Recent announcements of drugs being removed from the market due to the unexpected, long term effects of the drug are causing a re-emphasis on the way that the FDA, the industry, and consumers view clinical trials and drug safety research.
It is well recognized that the FDA drug review system is a gold standard and that the FDA maintains the highest worldwide standards for drug approval. However, experience has shown that the full magnitude of some potential risks do not always emerge during the mandatory clinical trials conducted before approval to evaluate these products for safety and effectiveness.
Occasionally, serious adverse effects are identified after approval either in post-marketing clinical trials or through spontaneous reporting of adverse events. Pharmaceutical executives are aware of the delicate nature by which this data must be delivered, and are continually seeking the best way to deliver what can at times be less than positive outcomes.
Through a clear understanding of drug safety outcomes, based on reliable data and a clear strategy for how to best deliver this data, pharmaceutical companies will empower themselves with the ability to manage the risks in publishing and disclosing safety outcomes data to the public.
There are several key areas that will be discussed and debated during this program, including Safety Data Analysis, a risk management framework for drug safety research, the FDAs guidance document on Post-Marketing Risk Assessment, Good Pharmacovigilancve Practices & Pharmacoepidemiologic Assessment, strategies for effective data transparency and corporate image management, emerging technologies to streamline risk management in drug safety reporting and post-marketing surveillance and best practices in the analysis of this data as well as optimal methods of information delivery.
For more information or to register, please visit the conference website.