Since the year 2000 there has been an increasing trend of registered clinical studies from approximately 4,000 in 2000 to 160,000 in 2014. In 2014 Forbes Magazine reported that the FDA had approved 44 drugs the highest in 18 years.
As innovation and new technological approaches are applied to the discovery of novel molecules, the number of studies will continue to increase to meet the areas of unmet medical needs and especially rare diseases. Clinical Trial.gov currently list 193,510 studies in 50 states and in 190 countries. Given the enormity of studies, the many clinical sites and the number of clinical professionals involved in these studies, guidelines and regulations have to be in place to direct the daily monitoring of the studies, training of staff and data management. Therefore it is important to have Standard Operating Procedures (SOPs) in place to outline the administrative duties, principal responsibilities, regulatory requirements and data management.
Why should you Attend: In clinical research, Standard Operating Procedures (SOPs) assist in defining the clinical groups standard practices and daily processes conducted to assure execution of research task in accordance with institutional, state and federal guidelines.
Since the 1970s the regulations for conducting clinical trials has been under the directions of the Food and Drug Administration’s Good Clinical Practice (GCPs) and human subject protection (HSP) Guidelines. The International Conference on Harmonization (ICH) defines a SOP as “Detailed, written instructions to achieve uniformity of the performance of a specific function”. In simple terms a SOP is a written process and a way for the clinical site(s) to perform a task the same way each time it is completed.
Areas Covered in the Session:
Who Will Benefit:
Harold Thibodeaux is a medical research scientist with in vivo pharmacological experiences in both academia and biopharmaceutical industry. During his prestigious career the focus of Mr. Thibodeaux’s research efforts has been on the efficacy of cardiovascular drugs most notably Hypertension, Myocardial Infarction, Focal Ischemia (Stroke), Beyond Advair Pulmonary Research and topical antibiotics. Optimal therapeutic benefits were the goal in all of these projects but cardiovascular safety to provide safer medicines to patients was a priority. Mr. Thibodeaux transitioned into the pharmaceutical industry when he joined the Cardiovascular Department of Genentech in 1990, as a technical lead with the Second Generation TPA Project Team. Mr. Thibodeaux is a graduate from the College of Charleston with a Bachelor of Science Degree in biology and is a member of The Safety Pharmacology Society.
Compliance4All DBA NetZealous,
Event Link : http://bit.ly/Regulatory_Requirements
LinkedIn Like us
Twitter Follow us
Facebook Like us