Technology in Alignment with EU Guidance & eClinical GPG

In light of the requirements discussed within the EU Guideline on computerised systems and electronic data in clinical trials and the information provided within the new GAMP Good eClinical Practice guide the workshop will explore challenges with implementing new technologies used in support of clinical trials, e.g.
1.  Decentralized Clinical Trials- Risks and concerns with the use of eClinical Platforms, e.g., ePRO, eCOA, IRT/RTSM; Roles and responsibilities for systems and validation; challenges in distribution of IMP; BYOD
2. Good Clinical Laboratory Practice- Consider the risks and concerns with the use of partners; data transfer; systems and validation
3. Data Science and AI-Enabled systems
4. Real World Data / Real World Evidence. OUTLINE

13:00 – 13:10 Welcome, Announcements, Introductions
13:10 – 13:30 Introduction to the eClinical Guide 2nd Edition and the EMA Guideline on Computerized Systems used in Clinical Trials
13:30 – 14:00 Decentralized Clinical Trials (DCT)
14:00– 14:30 Good Clinical Laboratory Practice 
14:30-15:00 - Break
15:00– 15:30 Data Science and AI-Enabled Systems
15:30– 16:00 Real World Data / Real World Evidence