China - NIS Training

Course Details

This training session provides foundational (essential) knowledge on the ethical and regulatory frameworks for non-interventional studies globally.  

Topics covered:

  • What is a non-interventional study (NIS)?
    • Definitions are Important…as is Context
  • What are the differences between NIS and Clinical Trials?
  • NIS – Regulatory Classification Decision Tree
    • Interventional or Non-Interventional?
  • NIS Terminology
  • Regulatory Framework for NIS
    • Ethical Foundation of NIS = Declaration of Helsinki
    • NIS Scientific Guidelines and Best Practice
    • Is ICH GCP Applicable to NIS
    • Pharmaceutical Company Self-Regulation
    • National NIS Regulatory Requirements
    • Benefits of Understanding the Ethical Foundation and Regulatory Framework for Non-Interventional Studies
  • Summary

What you get with your subscription:

  • Narrated training session
  • PDF of the training slides
  • PDF of the training slide notes

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£3603600
Single Seat License
Ideal for Consultants and Small Organisations
Monthly RWR Regulatory Updates
Country-Specific NIS Regulatory Requirements
NIS Training Modules
EU MDR Clinical Investigation Roadmaps and Detailed Requirements
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Teams
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£7207200
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Ideal for Medium Sized Organisations
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Monthly RWR Regulatory Updates
Country-Specific NIS Regulatory Requirements
NIS Training Modules
EU MDR Clinical Investigation Roadmaps and Detailed Requirements
Priority Support
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Ideal for Large Pharmaceutical, Biotech, Medtech Companies and Clinical Research Organisations
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Unlimited Seat License
Add More Users As Needed
Monthly RWR Regulatory Updates
Country-Specific NIS Regulatory Requirements
NIS Training Modules
EU MDR Clinical Investigation Roadmaps and Detailed Requirements
Priority Support
Personalised Onboarding
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Academic Pricing

Billed MonthlyBilled Annually
Save money with an annual plan
Academic Pro
Monthly
Yearly
£1801800
Single Seat License
Ideal for Small Research Projects
50% Compared to Commercial Membership
Single Seat Licence
Monthly RWR Regulatory Updates
Country-Specific NIS Regulatory Requirements
NIS Training Modules
EU MDR Clinical Investigation Roadmaps and Detailed Requirements
Cancel Any Time
Sign UpSign Up
Academic Teams
Monthly
Yearly
£3603600
Up to 5 Seat License
Ideal for Medium Sized Organisations
50% Discount Compared to Commercial Membership
Multiple Seat Licence
Add Users as Needed (Maximum 5 Users)
Monthly RWR Regulatory Updates
Country-Specific NIS Regulatory Requirements
NIS Training Modules
EU MDR Clinical Investigation Roadmaps and Detailed Requirements
Priority Support
Cancel Any Time
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Academic Enterprise
Monthly
Yearly
£POAPOA
Unlimited Seat License
Ideal for Large Academic and Not-for-Profit Organisations
Significant Discount Compared to Commercial Membership
Unlimited Seat Licence
Add Users as Needed
NIS Training Modules
Monthly RWR Regulatory Updates
Country-Specific NIS Regulatory Requirements
EU MDR Clinical Investigation Roadmaps and Detailed Requirements
Priority Support
Personalised Onboarding
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Cancel Any Time
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