WORKSHOPS LIST

 

1. Advanced Clinical Trial Training – Improving Efficiency and Quality in Clinical Trials
Duration: 2-days
Preferably undergone basic GCP training or GCP certification course
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This program is suitable for clinical research professionals with at least two years of experience in conducting clinical trials as Investigators, Sub-Investigators and Study Coordinators. This workshop will provide an advanced, in-depth understanding of the structural elements of Good Clinical Practice (GCP). Through problem-centric exercises and scenarios, participants will understand the practical application of GCP guidelines and local regulations for critical components of the clinical research process. Participants will be able to apply knowledge acquired from discussion of current quality issues to improve future clinical trial conduct.

 

2. Being an Investigator – Taking the Lead: Roles and Responsibilities within Clinical Trials
Duration: 1-day
Preferably undergone basic GCP training or GCP certification course
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This workshop is specifically designed for Sub-Investigators taking on an Investigator role, newly appointed Investigators or Sub Investigators being developed to take on the role of an Investigator. The expectations of the role of an Investigator as per ICH GCP will clearly be defined and importantly, how to demonstrate these via documentation will be discussed. Through a series of practical exercises, participants will understand the investigators roles and responsibilities, how to effectively and appropriately delegate tasks, thereby ensuring the rights, safety, well-being of clinical trial subjects is protected and data produced from the clinical trial is complete accurate and unbiased.

 

3. Creating a Clinical Trial Study Budget
Duration: 1-day
Preferably undergone basic GCP training or GCP certification course
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This workshop provides the practical skills needed to construct and negotiate study budgets that appropriately compensate investigative sites for resource needs required as a result of clinical research protocols. Participants will be taken through a detailed five-step process on how to create a clinical study budget. Factors impacting study budget will be discussed as well as budget templates will be provided with tips and tactics on budget negotiation also being discussed. A study budget will be created during the workshop.

 

4. Protection of Human Subject: Informed Consent and the Patient
Duration: 1-day
Preferably undergone basic GCP training or GCP certification course
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Protection of human rights is one of the fundamental principles of Good Clinical Practice. This workshop will discuss the history of informed consent, the development of the informed consent form and the informed consent process. The key issues in informed consent will be discussed and the roles of the Legally Acceptable Representative and Impartial Witness will be addressed. The dilemmas and issues in consenting vulnerable subjects will be discussed in detail. Current inspection findings will be presented. This is a very practical workshop incorporating role-play, problem scenarios and videos. The documentation expected to demonstrate compliance to the informed consent process will also be described in detail.

 

5. Preparing for a Regulatory Inspection
Duration: 1-day
Preferably undergone basic GCP training or GCP certification course
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The Inspector is coming! The key to effective management of regulatory inspections is preparation. This workshop will give an insight into what regulatory inspectors look for during an inspection and how the investigator should prepare for a regulatory inspection. This workshop will help participants determine how to build a robust system for handling regulatory inspections and ensuring that all employees follow the process.

Recent key Inspection findings will be presented and measures to proactively prevent them from occurring at sites will be discussed in detail.

 

6. Preparing for a Site Selection Visit
Duration: 1-day
Preferably undergone basic GCP training or GCP certification course
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For a clinical trial site to be selected for a clinical study, it must undergo a rigorous site selection process conducted by the sponsor. This workshop will provide an insight into what the sponsors expect from a clinical trial site and how this can be demonstrated. This practical workshop will provide guidance on how to prepare for a site selection visit, understand the rationale behind the key questions that are asked by the sponsor. Checklist and tools will be provided to guide the site for an upcoming site selection visit that will prepare and ensure that a site is successfully selected for a clinical trial.

 

7. Running Studies under the US IND
Duration: 1-day
Preferably undergone basic GCP training or GCP certification course
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In this workshop, the US FDA IND regulations relating to the conduct of clinical trials are discussed and what impact do they have on clinical investigators undertaking US IND studies outside the US. This workshop will focus on the FDA Code of Federal Regulations (CFR) surrounding the conduct of a clinical study under an IND, including CFR Part 50 (protection of Human Subjects), 54 (Financial Disclosure by Clinical Investigators), 56 (Institutional Review Boards (IRBs)), 312 (Investigational new Drug Application). The definitions, scope, inclusions and exclusions contained within the each of the CFR required of Investigators conducting clinical trials under an IND will be detailed. The differences between ICH GCP and US IND regulations will be highlighted. Practical exercise will include completion of the FDA 1572 form and problem solving scenarios.

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QUOTE OF THE WEEK

'A theory is something nobody believes, except the person who made it. An experiment is something everybody believes, except the person who made it.'


Albert Einstein
Nobel Prize Laureate (Physics)