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Effective Site Management
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on request | 2 dagen | Er komt heel wat bij kijken om als CRA een site goed te monitoren. Een CRA moet daarom - naast 'technische kennis’ - beschikken over een aantal bijzondere vaardigheden, die hem helpen het onderzoeksteam te laten doen wat er gedaan dient te worden.
Deze training is opgezet om deze vaardigheden te ontwikkelen en duurt twee dagen.
Meer info
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Regulatory Affairs, basic |
on request | 1 dagen | The aim of the course is to provide some basic understanding of regulatory affairs and the processes involved when applying for marketing authorization of a medicinal product.
Description
* Laws / Directives / Rules
* Role of authority
* Development of a drug
* Approval procedure
* Application documentation
* CTD module 1-5
* Life cycle of a product
* Product Information
Target group:
People needing a basic knowledge of the regulatory process, such as regulatory affairs assistants, clinical research managers and monitors.
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Application to Ethics Committee |
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On request | 1 dagen | The EU directive 2001/20/EC has resulted in a harmonised and simplier application process within the EU. To clarify and facilitate the interpretation of the requirements the EU commission has published a guidance document. The course will look at the guidance document together with national requirements to give participants a better understanding of how to apply to Ethics Committees.
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Monitoring, advanced |
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On request | 1 dagen | Het doel van deze training is het vergroten van de kennis over monitoring en de gebruikelijke zaken waar je mee te maken krijgt tijdens monitoring (teamwork, site management, investigator meeting, data quality & fraud, tracking tool, time management).
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Medical Devices |
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on request | 1 dagen | The aim of this course is to give participants a basic knowledge of the rules and laws regulating the development of Medical Devicse focusing on how and when to do Clinical Investigation.
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Data Management for non-DMs |
On request | 1 dagen | The aim of the course is to provide participants with a basic understanding of how to design CRFs and how data are processed.
Description:
CRF-design
* the aim of the CRF
* CRF vs protocol
* CRF vs Medical Record
* Instructions to investigators
* ICH GCP
* Monitoring of CRFs
* Source Document
* Paper vs electronic CRFs
Data Management
* Planning
* Database
* Verification and validation
* Queries
* Clean File/Database lock
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Monitoring, Basic |
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18 - 19 April 2012 | 2 dagen | The aim of this course is to provide training on how to monitor in compliance with the principles of GCP. Each type of monitoring visit will be discussed in detail so that participants can learn how to manage sites and deal with issues that may arise during monitoring.
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Good Clinical Practice |
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17 April 2012 | 1 dagen | The aim of this course is to provide a practical introduction to GCP as described in the ICH E6 guideline and EU Directives. Participants for subject safety and the roles and responsibilities of those working in clinical research.
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Introduction to Clinical Research |
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On request | 1 dagen | The aim of the course is to provide participants with an overall picture of the clinical study process so that they are better prepared for working in the clinical research environment.
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Clincal Study Protocol writing |
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On request | 1 dagen | The aim of the course is to introduce participants in how to write a clinical study protocol including study synopsis.
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Patient Information |
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On request | 1 dagen | The aim of the course is to provide participants with a better understanding of how to produce "Patient Information and Informed Consent Form" that comply with ethical and regulatory requirements.
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Biostatistics for non-statisticians |
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On request | 1 dagen | The aim of the course is to give participants a better understanding of the statistical issues in the design and analysis of clinical trials with the purpose of making their interaction with study statisticians more effective.
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Audits and Inspections |
On request | 1 dagen | The EU Directive requires that each member country has its own inspection programme with its own inspectors.
ICH GCP guidelines require that Sponsors/CROs have their own quality system with audit programmes. Thus, audits and inspections are an integrated part of work with clinical trials.
The aim of the training course is to provide participants with an increased understanding of what it means to be audited and inspected. Furthermore, the course will provide an increased understanding of what can be done to prepare for an audit or inspection and how one should respond to an audit report.
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Project Management for Clinical Research |
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On request | 2 dagen dagen | This course provides participants with an understanding of the principles of project management. Participants will learn how to apply project management principles to clinical research projects and will receive training in the use of project management tools designed for clinical research.
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Contracts and Agreements |
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On request | 1 dagen | The aim of the course is to provide participants with knowledge about the agreements in clinical trials and EU directives.
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Clinical Study Report writing |
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On request | 1 dagen | The aim of the course is to teach participants how to write clinical study reports including synopses and appendices in such a way that they fulfil the regulatory requirements.
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Pharmacovigilance, basic |
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On request | 1 dagen | The aim of the course is to provide participants with a basic understanding of pharmacovigilance and the rules and guidelines regulating safety reporting.
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CRF-design and Data Management |
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On request | 1 dagen | The aim of the course is to provide participants with a basic understanding of how to design CRFs and how to handle data.
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Biostatistics, advanced |
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On request | 1 dagen | The aim of the course is to provide participants with an in-depth understanding of biostatistics.
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EU Directives |
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On request | 1 dagen | Clinical Research conducted in the European member states is now regulated by a number of Directives and guidance documents. The aim of this course is to provide participants with a clear understanding of the contents and implications of these documents.
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Medical and Scientific writing |
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On request | 1 dagen | The aim of this course is to provide tools for effective and clear scientific writing.
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Non-Interventional Studies |
On request | 1/2 dag dagen | The aim of this course is to provide participants with an overview of the conduct of non-interventional studies.
Description:
Topics covered include
* Non-interventional vs interventional studies
* Need for Ethics Committee approval and Informed Consent
* Post-authorisation safety studies (PASS) ans Risk Management Plans (RMPs)
* Quality Assurance
* Good Epidemiological Practice (GEP)
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