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Introduction to the International Conference on Harmonisation (ICH)

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Overview 

The course, a Thomson Reuters Cortellis Regulatory Online Learning module, discusses the establishment of the International Conference on Harmonisation (ICH) technical requirements for registration of pharmaceuticals for human use by the EU, Japan, and United States. ICH membership, structure, and milestones are explored. The course describes the process for harmonisation, implementation of guidelines, and achievements reached in the three regions. The course concludes by describing the impact of ICH global harmonisation efforts on non-ICH countries.

Featured Topics 

  • International Conference on Harmonisation (ICH) technical requirements for registration of pharmaceuticals for human use
  • Process for harmonisation, implementation of guidelines, and achievements

Who Should Attend 

Professionals and experts in the pharmaceutical, biotechnology, and medical device fields

Learning Objectives 

Participants who complete this course should be able to:

  • Understand the rationale behind the development of the ICH
  • Describe ICH structure
  • Differentiate four categories of harmonisation proposals
  • Outline the steps of the formal ICH procedure
  • Describe the harmonisation achievements in the areas of drug efficacy, quality, safety
  • Recognise the impact of ICH global harmonisation efforts on non-ICH countries

The course takes an average of one hour to complete.

Contact Information 

Linda Belmont, DIA
Phone +1.215.293.5818
Linda.Belmont@diahome.org

Technical Requirements 

Click here for minimum system requirements.

Registration Fees 

Other Fees

Individual
$360.00
Register Online
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