Stephenson, a medical doctor with a particular interest in epidemiology and risk management, works closely with patients, academics/government, pharmacists, physicians and the industry to advance drug safety
in the US.
Founded in 2000, Drug Safety
Alliance (DSA) provides pharmacovigilance expertise to large and small pharmaceutical and biotechnology companies to ensure and improve patient safety.
3 million is earmarked for drug safety
efforts over the life-time of a drug.
Review and discussion of current government and industry drug safety
We will keep the promise of the FDA brand by putting in place more rigorous oversight and collecting and sharing important and emerging information about drug safety
The interoperability of health records is an essential element to our efforts to improve drug safety
and create value in health care.
Sam brings top industry experience and an in-depth understanding of drug safety
to OVATION," said Jeffrey S.
The growth of the global pharmacovigilance and drug safety
software market is mainly driven by increasing incidence rates of adverse drug reactions (ADRs), growing adoption of pharmacovigilance software by outsourcing companies (such as CROs and BPOs), and huge pressure on pharma companies to develop novel and safe drugs.
This is an expansion of Drug Safety
Navigator, LLC current services.
Traditionally, drug safety
groups have operated as drug safety
factories, which incurred significant capital expenses in building infrastructure related to technology, processes, people and other operational investments.
The new China-US agreement on drug safety
specifies new requirements for both countries for the registration and certification of drug ingredient manufacturers, as well as new procedures for information sharing, notification of adverse events, determination of counterfeits and facility access.
In response to a 2006 Institute of Medicine drug safety
report and recommendations, the Food and Drug Administration in January outlined a "comprehensive commitment" to drug safety
that includes strengthening science, improving communication and improving agency management.
On the heels of this news the FDA has issued final guidance that describes its current approach to communicating drug safety
information, including emerging safety information, to the public.
Officials at the Food and Drug Administration are planning to reorganize its Center for Drug Evaluation and Research in an effort to improve the agency's approach to drug safety
and to help improve drug development.
The current organizational structure perpetuates the mis-perception that ensuring drug safety
is solely the responsibility of the current Office of Drug Safety