CRED Project Management for Regulatory Affairs Professionals

Global Study Impact vs. Marketing Authorisation/Registration Goals

• Clinical Programme Start-Up timelines significantly increased • Clinical Research Investigators time is of essence. Delays with obtaining Regulatory and Ethics approvals impacts their availability to recruit patients and support the study. • Outreach to Sites and Patients delays • Patients miss the opportunity to take part in ground-breaking research • Perception of Sponsor (and CRO) at ECs/RAs • Pharmaceutical Companies – Retain a positive, responsible perception with the authorities [Broader Aspects – Impact on future projects]