Clinical Trials: The Role of Regulatory Agencies, Pharmacovigilance Laws, Guidelines, Risk Management, Patenting, and Publicizing Results The research carried out to find a better treatment, improve healthcare, and benefit the current medical practice is termed clinical research. Clinical tri... V Kan...
We are asked to look not just at the cold words of our public health statutes, but also at theCooper, Richard MFood Drug Cosm.l.jCooper, R.M. “The Role of Regulatory Agencies in Risk-Benefit Decision Making.” Food, Drug, and Cosmetic Law Journal 33 (December 1978):755–773....
Regulatory authorities, the pharmaceutical industry, professional societies, and other interested parties have responded by developing robust guidelines for interactions between the pharmaceutical industry and healthcare professionals. This, in turn, is driving change in the way that healthcare communications ...
The medical and scientific staff of a pharmaceutical company is dedicated to clinical research, product development, and interactions with regulatory agencies. The medical service also works with clinical colleagues in protocol design, grant and educational funding associated with research programs, and the...
Healthcare systems are complex and challenging for all stakeholders, but artificial intelligence (AI) has transformed various fields, including healthcare, with the potential to improve patient care and quality of life. Rapid AI advancements can revoluti
Phase 3 randomized controlled trials (RCTs), while the gold standard for treatment efficacy and safety, are not always feasible, are expensive, can be prolonged and can be limited in generalizability. Other under-recognized sources of evidence can also h
rulemaking regulators are often the agencies responsible for implementing policy mandates. these mandates can vary from being highly prescriptive to giving regulators great freedom to determine how to implement a policy. in some cases, regulatory agencies have been granted authority by congress to ...
On November 17, 2016, the second annual Patient-Reported Outcomes in Healthcare Conference brought together international stakeholders of medicine: regulatory bodies, funding agencies, payers/insurers, patient advocacy groups, quality-of-life researchers, clinicians, and physician specialty associations. This...
6 we’re not the only ones who agree. regulatory bodies see the importance too. last year, the fda passed new legislation asking for all study sponsors to submit a diversity action plan for phase 3 or pivotal studies of new potential treatments. 7 closing the healthcare gap it’s no...
advertise subscribe contact publications pme pme supplements communique t40 follow follow follow follow news research sales regulatory healthcare marketing intelligence intelligence webinars podcasts digital handbook orphan drugs & rare diseases glossary healthcare advertising gallery thought leadership appointme...