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ECTR Expert

Master the new ECTR regulation efficiently.

  • 7,5 hours
  • 4 modules 
  • online certificate
€ 95
excl. VAT
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Online ICH-GCP training

The ICH/GCP course is the perfect online training for research professionals working on international trials. 

  • case based
  • active learning
  • recognized GCP certificate
€ 175
excl. VAT
more information choose
Light PLUS ICH/GCP

The right choice for people contributing to some activities in global clinical research  but don't need to know every detail of GCP (yet)

  • 3 Modules
  • Interactive course
  • GCP light PLUS certificate
€ 99
excl. VAT
more information choose
Light ICH/GCP - Design

The light ICH/GCP course is ideal for research staff who contribute to international clinical trials, but do not need to know every detail of GCP.

  • 2 Modules
  • Short introduction course
  • GCP light certificate
€ 65
excl. VAT
more information choose
Blended GCP training

Learn all about GCP online and exchange knowledge with our trainer and your fellow students.

  • Incl. classroom training
  • GCP Addendum R2
  • recognized GCP certficate
€ 349
excl. VAT
more information choose
ECTR Foundation

The ECTR Foundation course gives you the fundamentals of the new ECTR regulation.

  • 1,5 hours 
  • 1 Module 
  • online certificate
€ 50
excl. VAT
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ECTR Conduct

Get ECTR fundamentals and learn about its requirements for the conduct of a drug trial.

  • 3,5 hours 
  • 2 modules 
  • online certificate
€ 65
excl. VAT
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ECTR Submission 

Get ECTR fundamentals and master preparing, and submitting dossiers.

  • 5,5 hours 
  • 3 modules 
  • online certificate
€ 80
excl. VAT
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ECTR Reviewers

Get ECTR fundamentals and master reviewing dossiers according to the new ECTR procedures.

  • 3 hours 
  • 2 modules 
  • online certificate
€ 65
excl. VAT
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Online EU/GCP Training

The interactive  EU-GCP course is ideal for CRAs, investigators and nurses, allowing you to conduct EU clinical trials in a GCP compliant way.

  • 7 Modules
  • TransCelerate acknowledged
  • recognized GCP certificate
€ 175
excl. VAT
more information choose
Blended EU/GCP training

Learn all about GCP and EU laws online and exchange knowledge with our trainer and your fellow students.

  • Incl. classroom training
  • EU legislation
  • recognized GCP certficate
€ 349
excl. VAT
more information choose
Light ICH/GCP - Preparation

The light ICH/GCP course is ideal for research staff who contribute to international clinical trials, but do not need to know every detail of GCP.

  • 2 Modules
  • Short introduction course
  • GCP light certificate
€ 65
excl. VAT
more information choose
Light ICH/GCP – Submission

The light ICH/GCP course is ideal for research staff who contribute to international clinical trials, but do not need to know every detail of GCP.

  • 2 Modules
  • Short introduction course
  • GCP light certificate
€ 65
excl. VAT
more information choose
Light ICH/GCP – Start

The light ICH/GCP course is ideal for research staff who contribute to international clinical trials, but do not need to know every detail of GCP.

  • 2 Modules
  • Short introduction course
  • GCP light certificate
€ 65
excl. VAT
more information choose
Light ICH/GCP – Conduct

The light ICH/GCP course is ideal for research staff who contribute to international clinical trials, but do not need to know every detail of GCP.

  • 2 Modules
  • Short introduction course
  • GCP light certificate
€ 65
excl. VAT
more information choose
Light ICH/GCP – Close-out

The light ICH/GCP course is ideal for research staff who contribute to international clinical trials, but do not need to know every detail of GCP.

  • 2 Modules
  • Short introduction course
  • GCP light certificate
€ 65
excl. VAT
more information choose
Light PLUS EU/GCP

The right choice for people contributing to some activities in EU clinical research  but don't need to know every detail of GCP (yet)

  • 3 Modules
  • Interactive course
  • GCP light PLUS certificate
€ 99
excl. VAT
more information choose
Light EU/GCP - Design

The light EU/GCP course is ideal for research staff who contribute to EU clinical trials, but do not need to know every detail of GCP.

  • 2 Modules
  • Short introduction course
  • GCP light certificate
€ 65
excl. VAT
more information choose
Light EU/GCP - Preparation

The light EU/GCP course is ideal for research staff who contribute to EU clinical trials, but do not need to know every detail of GCP.

  • 2 Modules
  • Short introduction course
  • GCP light certificate
€ 65
excl. VAT
more information choose
Light EU/GCP – Submission

The light EU/GCP course is ideal for research staff who contribute to EU trials, but do not need to know every detail of GCP.

  • 2 Modules
  • Short introduction course
  • GCP light certificate
€ 65
excl. VAT
more information choose
Light EU/GCP – Start

The light EU/GCP course is ideal for research staff who contribute to EU clinical trials, but do not need to know every detail of GCP.

  • 2 Modules
  • Short introduction course
  • GCP light certificate
€ 65
excl. VAT
more information choose
Light EU/GCP – Conduct

The light EU/GCP course is ideal for research staff who contribute to EU clinical trials, but do not need to know every detail of GCP.

  • 2 Modules
  • Short introduction course
  • GCP light certificate
€ 65
excl. VAT
more information choose
Light EU/GCP – Close-out

The light EU/GCP course is ideal for research staff who contribute to EU clinical trials, but do not need to know every detail of GCP.

  • 2 Modules
  • Short introduction course
  • GCP light certificate
€ 65
excl. VAT
more information choose
ECTR Expert

Our all inclusive ECTR Expert course helps you understand all the vital aspects of the ECTR regulation. You’ll learn all strategic elements, from study design, to submission, to clinical conduct in our course, making you the ECTR expert. This course teaches you everything you need to know about this new regulation, and you’ll walk away with a complete deep dive into ECTR regulation.

 

  • 7,5 hours
  • 4 modules 
  • Online ECTR certificate
  • Knowledge Test 
  • Available on desktop, smartphone or tablet

 

The e-learning ECTR Expert is intended for everyone who is responsible for product development and management, drug research design and / or strategic decisions. The e-learning offers a comprehensive insight into working according to the requirements of the new European legislation for clinical drug research, the ECTR. The e-learning is perfect for research and science coordinators, principal investigators (Investigator initiated research), Sponsors, Medical Directors, Head of ClinOps, Study Directors, Project Managers, CRAs, Monitors and people responsible for submitting dossiers.

€ 95
excl. VAT
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Online ICH-GCP training

The online ICH/GCP course is the online training solution for researchers, pharma professionals and research staff who conduct clinical trials in an ICH region, and need to be aware of the regulations applicable for clinical research with human subjects.

  • Transcelerate acknowledged GCP certificate
  • Efficient and interactive learning
  • Modular and easy accessible

 

The training consists of seven online training modules and represents a total workload of 6 hours. The modules are divided into chapters of 10 minutes and consist of all laws and regulations which apply to international clinical trials, including the Declaration of Helsinki, ICH-GCP E6 Addendum R2, Code of Federal Regulations (US), EU Directives & Regulation, and Privacy laws (GDPR).

Make sure to buy the right training for your situation: Are you involved in clinical research in the Netherlands? Choose the online WMO/GCP training. Is your focus on European clinical trials? The EU/GCP training in the webshop is the training that suits you. 

€ 175
excl. VAT
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Light PLUS ICH/GCP

Ideal entry course for students and clinical staff involved in global clinical trials. In 3 modules you’ll learn about the basic principles of GCP and get detailed knowledge required for two specific steps in a clinical trial: trial start and conduct.

  • 3 Hours
  • Efficient and interactive learning
  • Modular and easy accessible

More Tasks? Easily add more modules to complete your online ICH/GCP Training.

€ 99
excl. VAT
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Light ICH/GCP - Design

The light ICH/GCP training is your online introduction in clinical research. An entry level course, applicable for students and site staff that conduct some tasks in GCP regulated research. The light training with module Design provides knowledge of the basic principles of Good Clinical Practice (GCP), protocol development, design of essential documents and the selection of researchers and research sites.

  • 2 hours
  • Focussed on clinical research in ICH regions

More Tasks? Easily add more modules to complete your online ICH-GCP training

€ 65
excl. VAT
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Blended GCP training

The blended GCP training is the optimal mix: learn about Good Clinical Practice guidelines online, at your own pace, and attend the additional classroom training in Amsterdam. During the classroom session, you will be challenged to use your knowledge to solve case studies, you can ask questions to the trainer and exchange knowledge and experiences with fellow students.

16 hours total (8 online, 8 classroom)

  • in Dutch and English
  • exchange knowledge in the classroom session
  • acknowledged ICH/GCP certificate

Would you like to learn about the legislation applicable in Europe? Choose the blended EU/GCP training instead and learn about the EU directives online.

The next classroom sessions in 2019 are Friday September 6 en Friday December 13 2019. 

€ 349
excl. VAT
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ECTR Foundation

Be ECTR ready. This e-learning course explains what the regulation is, clarifies the critical timelines, helps you understand the changes and be prepared for its implications.

 

  • 1,5 hours
  • 1 Learning Module 
  • Online ECTR certificate 
  • Knowledge Test 
  • Available on desktop, smartphone or tablet

 

The ECTR Foundation course is applicable to everyone (clinical and non-clinical) who is involved in, or interested in, medical scientific and clinical drug research. This e-learning course explains what the regulation is, clarifies the critical timelines, helps you understand the changes and be prepared for its implications. The e-learning is perfect for medical doctors, nurses, patients, students (medicine or biology), Clinical Trial Assistants, employees of CROs, and employees of (hospital) pharmacies.

€ 50
excl. VAT
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ECTR Conduct

Our ECTR Conduct e-learning course gives you the essentials on the upcoming ECTR regulation, as well as an in-depth understanding of how to conduct clinical drug research according to the new EU regulation, such as safety and trial reporting, submitting amendments, and quality control. Learn how to avoid breaches and quality issues, and what to do if they happen, as well as learning how to collaborate effectively.

  • 3,5 hours
  • 2 Learning Modules
  • Online ECTR certificate
  • Knowledge Test
  • Available on desktop, smartphone or tablet

 

The e-learning ECTR Conduct is intended for everyone involved in the conduct of clinical drug research. The e-learning offers a complete overview of the impact of the new regulation for conducting clinical drug research. The e-learning is perfect for research nurses and medical doctors involved in drug research.

€ 65
excl. VAT
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ECTR Submission 

Deep dive into preparing and submitting submission packages with our ECTR Submission e-learning course, as well as the fundamentals of the new ECTR regulation. Bring your strategies, roles, dossier contents, patient information and study feasibility, plus other important changes in line with the new regulation, as well as learning the fundamentals of the ECTR.

 

  • 5,5 hours
  • 3 Learning Modules
  • Online ECTR certificate
  • Knowledge Test
  • Available on desktop, smartphone or tablet. 

 

The e-learning ECTR Submission is intended for everyone involved in the design, preparation and submission of clinical drug research dossiers. The e-learning offers a complete overview of the impact of the new regulation on the submission of dossiers in for medical-ethical review. The e-learning is perfect for start-up specialists, start-up departments in drug companies and CROs and research coordinators in hospitals responsible for submission of dossiers.

€ 80
excl. VAT
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ECTR Reviewers

Our ECTR Reviewers eLearning course not only helps you understand the upcoming ECTR regulation, but offers a clear and in-depth understanding of the critical roles and timelines involved with the medical-ethical reviewing process of dossiers. Learn about the new timelines for reviewers, the assessment method and how to address questions at the submitter of the dossier.

  • 3 hours
  • 2 Learning Modules
  • Online ECTR certificate
  • Knowledge Test
  • Available on desktop, smartphone or tablet. 

 

The e-learning ECTR Reviewers is for everyone who is member of an ethics committee and/or responsible for evaluating clinical drug research. The e-learning offers detailed insights into the ECTR and the impact of its implementation on the assessment process. The e-learning is perfect for ethics committee members across Europe.

€ 65
excl. VAT
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Online EU/GCP Training

The online EU-GCP course is the perfect choice for research staff working on EU clinical trials who need knowledge of the ICH-GCP guidelines and European legislation.

  • 6 Hours
  • Efficient and interactive learning
  • Modular and easy accessible
  • Practical explanation of GCP in a logical order: from design to close-out

The modules are divided into chapters of 10 minutes and consist of all laws and regulations which apply to international clinical trials, including the Declaration of Helsinki, ICH-GCP E6 Addendum R2, EU Directives (2001/20 / EC and 2005/28 / EC) and Privacy laws (GDPR).

€ 175
excl. VAT
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Blended EU/GCP training

The blended EU/GCP training is the optimal mix: learn about Good Clinical Practice guidelines and European legislation online, at your own pace, and attend the additional classroom training in Amsterdam. During the classroom session, you will be challenged to use your knowledge to solve case studies, you can ask questions to the trainer and exchange knowledge and experiences with fellow students.

  • 16 hours total (8 online, 8 classroom)
  • in Dutch and English
  • exchange knowledge in the classroom session
  • acknowledged ICH/GCP certificate

The next classroom sessions in 2019 are Friday September 6 en Friday December 13 2019. 

€ 349
excl. VAT
All devices
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Light ICH/GCP - Preparation

The light ICH/GCP training is your online introduction in clinical research. An entry level course, applicable for students and site staff that conduct some tasks in GCP regulated international research. The light training with module Preparation provides knowledge of the basic principles of Good Clinical Practice (GCP), creating product information (IMPD), deliver the investigational product to the site, and discusses insurances and contracts.

 

  • 2 hours
  • Focussed on clinical research in ICH regions

More Tasks? Easily add more modules to complete your online ICH-GCP training

€ 65
excl. VAT
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choose
Light ICH/GCP – Submission

The light ICH/GCP training is your online introduction in clinical research. An entry level course, applicable for students and site staff that conduct some tasks in GCP regulated clinical research. The light training with module Submission provides knowledge of the basic principles of Good Clinical Practice (GCP), submission of the standard dossier to the ethics committee, the reviewing procedure and timelines of review.

  • 2 hours
  • Focussed on clinical research in ICH regions

More Tasks? Easily add more modules to complete your online ICH-GCP training

€ 65
excl. VAT
All devices
choose
Light ICH/GCP – Start

The light ICH/GCP training is your online introduction in clinical research. An entry level course, applicable for students and site staff that conduct some tasks in GCP regulated clinical research. The light training with module Start provides knowledge of the basic principles of Good Clinical Practice (GCP), recruit and inform subjects/patients, the informed consent process and privacy of medical and research data.

  • 2 hours
  • Focussed on clinical research in ICH regions

More Tasks? Easily add more modules to complete your online ICH-GCP training

€ 65
excl. VAT
All devices
choose
Light ICH/GCP – Conduct

The light ICH/GCP training is your online introduction in clinical research. An entry level course, applicable for students and site staff that conduct some tasks in GCP regulated clinical research. The light training with module Submission provides knowledge of the basic principles of Good Clinical Practice (GCP), safety and medical care to subjects, documentation and data management of research, and clinical monitoring.

  • 2 hours
  • Focussed on clinical research in ICH regions

More Tasks? Easily add more modules to complete your online ICH-GCP training

€ 65
excl. VAT
All devices
choose
Light ICH/GCP – Close-out

The light ICH/GCP training is your online introduction in clinical research. An entry level course, applicable for students and site staff that conduct some tasks in GCP regulated clinical research. The light training with module Close-out provides knowledge of the basic principles of Good Clinical Practice (GCP), reporting end of study, filing clinical study data and archiving requirements.

  • 2 hours
  • Focussed on clinical research in ICH regions

More Tasks? Easily add more modules to complete your online ICH-GCP training

€ 65
excl. VAT
All devices
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Light PLUS EU/GCP

Ideal entry course for students and clinical staff involved in EU clinical trials. In 3 modules you’ll learn about the basic principles of GCP and get detailed knowledge required for two specific steps in a clinical trial: trial start and conduct.

  • 3 Hours
  • Efficient and interactive learning
  • Modular and easy accessible

More Tasks? Easily add more modules to complete your online EU-GCP Training.

€ 99
excl. VAT
All devices
choose
Light EU/GCP - Design

The light EU/GCP training is your online introduction in clinical research. An entry level course, applicable for students and site staff that conduct some tasks in GCP regulated research. The light training with module Design provides knowledge of the basic principles of Good Clinical Practice (GCP), protocol development, design of essential documents and the selection of researchers and research sites.

  • 2 hours
  • Focussed on clinical research in EU regions

More Tasks? Easily add more modules to complete your online EU-GCP training

€ 65
excl. VAT
All devices
choose
Light EU/GCP - Preparation

The light EU/GCP training is your online introduction in clinical research. An entry level course, applicable for students and site staff that conduct some tasks in GCP regulated research. The light training with module Preparation provides knowledge of the basic principles of Good Clinical Practice (GCP), creating product information (IMPD), deliver the investigational product to the site, and discusses insurances and contracts.

 

  • 2 hours
  • Focussed on clinical research in EU regions

More Tasks? Easily add more modules to complete your online EU-GCP training

€ 65
excl. VAT
All devices
choose
Light EU/GCP – Submission

The light EU/GCP training is your online introduction in clinical research. An entry level course, applicable for students and site staff that conduct some tasks in GCP regulated clinical research. The light training with module Submission provides knowledge of the basic principles of Good Clinical Practice (GCP), submission of the standard dossier to the ethics committee, the reviewing procedure and timelines of review.

  • 2 hours
  • Focussed on clinical research in EU regions

More Tasks? Easily add more modules to complete your online EU-GCP training

€ 65
excl. VAT
All devices
choose
Light EU/GCP – Start

The light EU/GCP training is your online introduction in clinical research. An entry level course, applicable for students and site staff that conduct some tasks in GCP regulated clinical research. The light training with module Start provides knowledge of the basic principles of Good Clinical Practice (GCP), recruit and inform subjects/patients, the informed consent process and privacy of medical and research data.

  • 2 hours
  • Focussed on clinical research in EU regions

More Tasks? Easily add more modules to complete your online EU-GCP training

€ 65
excl. VAT
All devices
choose
Light EU/GCP – Conduct

The light EU/GCP training is your online introduction in clinical research. An entry level course, applicable for students and site staff that conduct some tasks in GCP regulated clinical research. The light training with module Submission provides knowledge of the basic principles of Good Clinical Practice (GCP), safety and medical care to subjects, documentation and data management of research, and clinical monitoring.

  • 2 hours
  • Focussed on clinical research in EU regions

More Tasks? Easily add more modules to complete your online EU-GCP training

€ 65
excl. VAT
All devices
choose
Light EU/GCP – Close-out

The light EU/GCP training is your online introduction in clinical research. An entry level course, applicable for students and site staff that conduct some tasks in GCP regulated clinical research. The light training with module Close-out provides knowledge of the basic principles of Good Clinical Practice (GCP), reporting end of study, filing clinical study data and archiving requirements.

  • 2 hours
  • Focussed on clinical research in EU regions

More Tasks? Easily add more modules to complete your online EU-GCP training

€ 65
excl. VAT
All devices
choose
 
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