Training Institute For Clinical Research | Pharmacovigilance
Best Clinical Research Course by Fusion Technology Solutions
Being one of the best institute for training and placements Fusion technology solutions ha designed an outstanding Clinical Research Institute In Pune for investigators and managers involved in preparation of various documents used in clinical trials such as protocols, new drug application, study reports, papers for publication and submission to the regulatory authorities etc.
Medical professionals need training in clinical research, as this is not covered in medical curriculum. We are providing training to such candidates to supply qualified professionals to pharmaceutical industry and to increase the quality products. Clinical Trial is a way to test new methods of diagnosing, treating, or preventing health conditions. The aim is to determine whether something is both safe and effective.At Fusion Technology solutions, we believe that in today’s world of knowledge, it is critical to know what, when, and how to study. We assign mentors to all candidates, who help students untangle the challenges faced in creating a rewarding career in the Clinical Research Courses In Pune.
· The objective of the course is to train students to identify undesirable Clinical trials, Pharmacodynamics properties of a substance that may have relevance to human safety.
· To evaluate adverse pharmacodynamics, clinical research and/or pathophysiological effects of a substance observed in toxicology and/or clinical studies.
· To investigate the mechanism of adverse clinical research, Pharmacovigilance, pharmacodynamics effects observed/ or suspected.
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Prerequisite for the Clinical Research Course
The Course is designed for graduates in science, medical, dental, nursing, veterinary sciences, pharmaceutical sciences and postgraduates in biology, biotechnology, and bioinformatics etc.
Detailed Syllabus of Clinical Research Training
1. Clinical Research Basic & Drug Development Process.
Review FDA approved process for development and approval of a drug, role of key player in drug development.
2. Informed consent process and human subject protection.
Key events in history that have impacted human subject rights, review informed consent process and describe regulatory requirements.
3. GCP Regulation and Guidelines.
Key concept in regulatory application such as GCP, regulation guidance and ICH guide lines. Review mandatory regulations of FDA that apply to sponsor investigator and IRB.
4. Collection of Regulatory Documents, Review and Submission Review the regulatory documents which must be collected and maintained, discuss the role of these regulatory documents, identify strategies to ensure their accurate completion, review management of study files.
5. Adverse events (AE) and Serious adverse events (SAE) Introduction of AE and SAE to the management that occur during the conduct of a clinical study, outline regulatory expectations for the identification, documentation and reporting of these events to the sponsor and FDA. , review process and the system involved in safety management and Pharmacovigilance in both domestic and global trials.
6. The Protocol and Data Management
Review the purpose of the protocol and key factors both from CRA and site prospective, and their role in handling protocol departures, types of data collection and regulatory requirement and industry standards for collecting retrieving and analyzing subject data.
7. Site interactions
Review communication skills and concepts for interacting with site personnel; indicate key principles for establishing productive work relationship and strategies for handling site problems.
8. Managing clinical supply/ laboratories
Review CRAs role and regulatory responsibilities for managing clinical supply laboratories and test articles accountability during the conduct of a trial. Address issues of test, noncompliance and the policy to prevent or address noncompliance.
9. FDA inspections
Review the purpose of FDA inspections, preparation for an FDA inspection, activity during an inspection, and outcome of an inspection activity following FDA inspections
10. Source Document Verification
A brief review of basic data management concepts, discuss actual process of source documentation verification, addressing CRAs responsibilities, strategies and helpful hints for attacking data and problem resolution.
11. Training Orientation
Review role of monitor trainee including site objectives, pre-approval Requirements for site visits, site visit planning, site visit expenses and expense forms, site visits SOPs and documentation and sign of for training to perform independent site visits.
12. Interim visits
Review the activities that take place during interim site visits and discuss the methodology for solving the most common problem that occur at investigative sites.
13. Site close out audit and inspections
Familiarize new CRAs with activities that occur at the end of a trial and their responsibilities for completion of these activities.
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