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 drug developers, pharmaceutical and biotech companies, clinical trial sponsors and marketing authorization holders, participants of the clinical trial market, doctors.
Victoria Yavorskaya, Medical Advisor, IPHARMA
How to participate?
To participate in the webinar you should register.
On September, 20th, you will receive an email invitation with a link to the broadcast.
Participation is free of charge.
Can I ask the questions?
You can ask preliminary questions which you would like to discuss in the registration application.
It is also possible to ask questions in Chat form during the broadcast on the YouTube channel, you will need to log in with your Google Account or create an account.
What if I miss the webinar?
All webinars are recorded and you can watch it on YouTube IPHARMA channel.