Webinar on SOPs for Clinical Trials: Regulatory Requirements
Overview:
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.
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:
- ICH guidelines and Good Clinical Practice (GCP)
- Standard Operating Procedures (SOPs)
- Benefits of SOPs
- Writing SOPs
- Highlight Different SOP Topics
- Regulatory Requirement of SOPs
- Importance of SOPs in Data Management
- Study Participant Recruitment Plans
- Healthcare Providers in Clinical Research
- New Clinical Research Coordinators (1-2 years)
- New Principal Investigators
- Administrative Managers in charge of Clinical Research
- Regulatory Compliance Associates and Managers
- Medical Writers
- Nursing and/or Clinical Monitoring Staff
- Marketing Team Members
Speaker and Presenter Information
Harold Thibodeaux
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.
Relevant Government Agencies
Regulatory Requirements
Event Type
Webcast
This event has no exhibitor/sponsor opportunities
When
Thu, Jun 2, 2016, 1:00pm - 2:30pm
ET
Website
Click here to visit event website
Organizer
Compliance4All
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