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This interactive course with workshops is designed to provide an educational and reference tool for anyone interested in clinical research. This course provides the necessary background and insights into the European GCP requirements.
Audience
Clinical Researchers, Clinicians, Scientists, Clinical trial monitors; any person involved in Clinical Research; Management
Time Schedule
08:30 - 09:00
Registration & coffee
09:00 - 17:00
Course (lunch included)
Price
€ 2420
per participant (excl. VAT)
✓ Exclusive learning approach
✓ Personal course documentation
✓ Lunch, water, coffee & tea
✓ Networking
✓ Course certificate after completion
Location
Quastion Learning Center (Qplus consult BVBA)
Leuvensesteenweg 643 bus 7, 1930 Zaventem, Belgium
Your Trainer
Kristina Bindus
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Founder & CEO of Qplus consult that focuses on leverage of pharmaceutical expertise across Pharmacovigilance, Medical, Quality, Auditing & Regulatory Affairs.
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Co-founder of Webcaststudio.be and Belgian internet radio Singjaal.
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Strategic Advisor & Trainer specialized on interpretation & implementation of EU pharmaceutical law who cares about Quality, Safety and Efficacy of Medicines.
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Kristina is specialized in online medical communication: webcast, webinar and e-learning.
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She has developed a universal auditing techniques and coaches auditors to use auditing methodology for an effective assessment result.
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Kristina has an extensive experience in Quality & Pharmacovigilance.
Program
Introduction to ICH-GCP
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Historical background
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Definition and scope
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13 Core principles
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Guidelines content
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Legislation
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Clinical development programme
Responsibilities of Sponsor
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Definition
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Main responsibilities
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Trial design, management and reporting
o Clinical trial protocol:
- Definition and remit
- Content
- Transparency
o Trial management, data handling, record keeping
o Trial Master File (Essential documents)
o Record access
o Safety review and reporting
o Premature termination or suspension of trial
o Notification/submission to regulatory authorities
o Reporting of results
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Resources
o Investigator selection
o Medical expertise
o Delegation to a CRO
o Allocation of responsibilities
o Appoint monitors
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Quality assurance and quality control
o IRB/IEC review confirmation
o Audit
o Non-compliance actions
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Financing
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Investigational product
Responsibilities of Investigator
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Qualifications
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Key roles & responsibilities of a clinical research investigator
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Definition and details about investigator`s brochure
Responsibilities of Ethics Committee
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Definition
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Difference between IRB and IEC
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Main responsibilities
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Membership
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Procedures
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Functions and operations
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In relation with investigator and sponsor
Patient Recruitment
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Informed consent:
o Definition of Informed consent
o Critical points and content
o Process
o Who
Conduct and Monitoring
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Trial monitoring purpose and qualifications
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Responsibilities
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Monitoring report
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Audit
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Source data and source documents
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Case Report Form
o Definition
o Content
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Safety data
o Adverse Event
o Adverse Drug Reaction
o Unexpected Adverse Drug Reaction
o Serious Adverse Event
Essential Documents during the Trial Conduct
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Overview documents necessary during the trial conduct
Closure
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Criteria
Result Analysis and Interpretation
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Clinical Study Report
o Definition and purpose
o Content
Essential Documents after Completion of the Trial
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Overview documents after completion of the trial
Communication of Trial Results
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Clinical Study Report communication
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Publication
Data Filed and Registration Obtained
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According ICH-GCP
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World Health Organization