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Cases and

webinars

Webinar “General requirements for the conduct of clinical trials in EEU (ICH E8, ICH E1)”

The webinar is dedicated to observation of the EEU Guideline "General considerations on clinical trials. EEU Guideline (based on ICH E8, ICH E1)". This guideline reveals general principles of the clinical study conduct, described in ICH E8, and provides recommendations for the extent of population exposure to assess clinical safety of the drugs intended for the long-term treatment of non-life-threatening diseases. ICH E1 is a tool for protecting a patient from serious and uncertain risks from a new (original) marketed product.

 

What will we discuss in Webinar?

 

  • clinical trials classification

  • clinical trials methodology

  • phases of clinical trials

  • approaches to clinical trial designs (choosing endpoints, number of patients, etc.)

  • analyzing the data obtained

For whom?

 

For drug developers, pharmaceutical and biotech companies, clinical trial sponsors and marketing authorization holders, participants of the clinical trial market, doctors.

Host:

 

Victoria Yavorskaya, Medical Advisor, IPHARMA