On-demand Poster presentation: EU-CTR readiness for sponsors: A pilot study of in-scope documents for public disclosure
Session Chair(s)
Hitesh Manchanda, MPharm
Associate Director
Syneos Health, India
Learning Objective : • To understand efforts and time needed in evaluating in-scope documents for public disclosure under EU-CTR 536/2014 and categorization of CCI & PPD
• To evaluate EU-CTR readiness through a trial run of current processes and tools
• To assess vendor process framework for future EU-CTR submissions
