Date: 10th – 11th October 2023
Location: Milan, Italy – At Bayer
Attending: Andrea Nizzardo
The next IBIG Forum is coming! #IBIGFORUM2023
After last year’s great success, the IBIG Forum looks forward to meeting you again this year to share experiences, address similar statistical issues from different angles, and have fun together!
Our Research Expert Biostatistician • Pharmacometrics, Andrea Nizzardo, will chair a session on “The estimands journey: from theory to practice”
Summary:
The estimands framework has been introduced in 2019 by the Addendum to the ICH E9 guideline on statistical principles for clinical trials to improve alignment between clinical questions, objectives, design, and analysis of clinical trials. Since its release, the addendum has rapidly impacted the drug development world, triggering interest and discussions. Many efforts have been made to clarify the theory behind the framework to strengthen the interaction between relevant stakeholders and between sponsors and regulators. Now that the framework has started to be broadly adopted, several challenges have arisen during its implementation. The session will focus on experiences and case studies on practical issues encountered when adopting the framework in clinical trials.
When?
Pre-Forum courses: 9 October
IBIG Forum 2023: 10 and 11 October.
Where?
Milan, at Bayer (https://lnkd.in/dqUZCMYp)
What?
Five Forum sessions with quality interventions and speakers on current topics and innovative approaches:
· Artificial Intelligence and Machine Learning
· Historical data supporting drug approval
· Decision Making
· Estimands Application
· Real World Evidence
Plus two very interesting and applicative pre-forum courses:
· A pragmatic approach to multiple endpoints resolution
· R in Clinical Trial Reporting
Registrations are still open at this link: https://lnkd.in/dMsPqq4M
