| Courses + Workshops |
Course code |
Short description |
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A001
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The purpose of this course and workshop is to provide an all-inclusive background in Good Clinical Practices (GCPs) for clinical trials conducted in worldwide. This course emphasizes GCP requirements and quality assurance functions for clinical trials for the sponsor-monitor and their QA groups, Institutional Review Boards (IRBs), the clinical investigators, and regulatory authorities.
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A002
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The purpose of this workshop is to introduce clinical and regulatory personnel to the audit process and how to handle their outcome.
The pharmaceutical, biotech and medical device industry is highly regulated and clinical investigation has to comply with strict guidelines to ensure the protection of human subjects and the integrity of data. Clinical trials gather valuable data about the safety and efficacy of new compounds or devices. Audits focus on the processes concerning data acquisition, collection, transfer and analysis.
Regulatory authorities (FDA) conduct audits or inspections at investigator sites, IRB’s/ERB’s, and at the sponsor’s site. Those audits or inspections have the purpose to verify compliance with GCP and country specific regulations. The FDA also conducts inspections outside the US (e.g. Canada, EU) to verify that data generated in the audited country complies with FDA regulations for US submissions.
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A003
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The main objective of this course is to provide the participant with a clear picture of clinical research. Regulatory requirements and Good Clinical Practices are going to be reviewed in a summarized manner to allow easy comprehension and learning. It’s a MUST attend course for the recent graduate who is planning to start a career in the pharmaceutical industry
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A004
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The Clinical Trials Coordinator is an active very critical position where responsibility, management and accountability are a prime factor. Regulatory requirements and international studies increased the level of complexity of clinical trials where extremely organized and knowledgeable coordination is essential for the successful completion of the study.
The Clinical Trials Coordinator program includes every activity the coordinator will be involved in during a clinical trial at an investigator site. The program includes the compete process of clinical trials and drug/medical device development in the industry and academia. The course will be based of ICH/GCP (Good Clinical Practices) for Clinical Research, and FDA/Health Canada Requirements.
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A005
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This course is customized to introduce Principal Investigators of the academia and those working for industry-sponsored clinical trials on how to successfully conduct clinical trials at the investigators site. All requirements are reviewed and real cases scenarios are presented to allow the participant understand compliance to regulatory requirements, communication to ethics boards and their responsibilities.
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A006
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The purpose of this course and workshop is to provide and strengthen expertise to the process of monitoring clinical trials from phases I to IV. Any changes in regulatory requirements for monitoring clinical trials will be analyzed in detail as per Good Clinical Practices. Also novel monitoring strategies will be discussed (e-monitoring and real time monitoring). The participant will be able to monitor clinical trial documents during the course and workshop to allow consolidation of new acquired information with previous experience.
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A007
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The Clinical Trials Nurse Coordinator is an active very critical position where responsibility, management and accountability are a prime factor. The Clinical Trials Nurse assists the investigator on specific activities where the nursing expertise is necessary.
Since regulatory requirements and international studies increased the level of complexity of clinical trials where extremely organized and knowledgeable coordination is essential for the successful completion of the study.
The Clinical Trials Nurse Coordinator program includes every activity the RN coordinator will be involved in during a clinical trial at an investigator site. The curriculum includes the compete process of clinical trials and drug/medical device development in the industry and academia. The course will be based of ICH/GCP (Good Clinical Practices) for Clinical Research, and FDA/Health Canada Requirements.
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MASTER Certificate in Pharmaceutical R&D Buisiness Management
Please contact us for more information...
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A008
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Coming up soon...
Please contact us for more information...
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DMR01
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This is a 2 day course and workshop where the candidate will walk through the process of clinical trial data capture, transfer and verification as well as resolution and regulatory compliance.
Source documentation and electronic systems as well as 21 CFR 11 and its impact in clinical research will be discussed. This is a hands on course designed with real examples where the participant will learn about all the issues regarding clinical trial data handling. The concept of numeric and aphfanumeric data capture and transfer as well as out of field clinical trial data will be presented to allow the participant understand the complexity of clinical trial data.
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PIC01
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The Patient Information and Consent Process is the cornerstone for patient protection. This course was designed to provide the most in depth information of the consent process for studies under an IND and any other GCP compliant study. Every investigator site must ensure that proper compliant informed consent was obtained and that all reasonable risks were disclosed to the subject.
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GCLP01 |
“GCP (Good Clinical Practices) /GLP (Good Laboratory Practices) an intersection in Clinical Research- (GCLP01)” a 2 day intensive program that will present the issues on clinical trials that are unconventional and every day more common”. This program will prepare the principal investigator to also assume the role of the sponsor, and to understand the very essence on running clinical trials with FDA regulated products.
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IRB01 |
The objective if this course is to provide participants from different professional backgrounds the necessary knowledge to perform as an IRB member in a compliant and well-informed manner. This course also involves a workshop where warning letters issued by the FDA are analyzed and violations are identified as well a possible action to avoid non compliance is discussed.
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Programs