Pre-Conference Workshops

Take your CDM skills to the next level.

Discover the #EMEA25 workshops

Wednesday, 9 April 2025
The EMEA25 pre-conference day is filled with engaging and interactive Pre-Conference Workshops, designed to take your CDM skills to the next level. Delivered by industry experts, these sessions were specifically crafted to provide practical, actionable strategies you can implement in your day-to-day job.
The EMEA25 pre-conference day was filled with engaging and interactive Pre-Conference Workshops, designed to take your CDM skills to the next level. Delivered by industry experts, these sessions were specifically crafted to provide practical, actionable strategies you can implement in your day-to-day job.

Richard Young & Sas Maheswaran, CluePoints

Risk-based Quality Management (RBQM) in Clinical Data Management

Wednesday, 9 April, 2025 | 9:00 AM to 12:30 PM

In this hands-on, practice-oriented session, you will discover how RBQM implementation helps us “listen to the data” and optimize trial outcomes. Learn to identify Critical to Quality Factors (CTQs), assess study-specific risks, and design effective Centralized Monitoring strategies that enhance data quality and participant safety. Drawing from real study examples, this workshop equips you with the tools to apply RBQM principles and drive better clinical trial results.

Dawn Kaminski, eClinical Solutions & Dan Crawford, Veeva Systems

Data Requirements for an FDA Submission

Wednesday, 9 April, 2025 | 1:30 PM to 5:00 PM

This workshop will provide an overview of the requirements for submitting standardized electronic data and documents to Regulatory authorities (FDA, EMA). We will look at the differences between a submission to the EMA and FDA and also highlight some of the tools the FDA uses to facilitate their review and their approach to reviewing the safety and efficacy portions of a submission.