Page History

Real World Evidence Community Forum – RWD Quality Challenges – Different Perspectives

• This was the first Working Group event of the year, with 114 attendees listening to Dr Cheryl Grandinetti, FDA andKris Wenzel, MMS discuss the different opportunities in using real-world data in drug development. Both speakers shared their perspectives of both regulatory and data provenance.

Risk Based Quality Management Community Forum – The Risk Based Monitoring Feedback Loop

• The Risk Based Quality Management Working Group held their first Community Forum, with Vera Pomerantseva giving an excellent presentation on The Risk Based Monitoring Feedback loop. This was an interactive session with 61 attendees, many of whom asked questions and gave feedback.