09:00–09:20

Welcome and introductions

All

09:20–10:00
40 minutes

S1: Key regulatory and guidelines requirements
for setting up and running clinical trials

• EU Clinical Trial Regulation (536/2014) for clinical trial authorization
• Ethical approval

• 35-minute lecture
• 5-minute moderated discussion

10:00–11:00
60 minutes

S2: The importance of ICH GCP R2 guideline requirements
for running clinical trials

• International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) principles
• Investigator responsibilities and discussion on how to demonstrate these
• Informed consent considerations (discussion of the essential requirements to include)
• Trial documentation
• Ensuring quality and data integrity

• 45-minute lecture
• 15-minute moderated discussion

11:00–11:20 

Refreshment break and interactive poster wall

All

11:20–12:15
55 minutes

S3-a Practical exercise: Setting up a clinical trial
(for new drugs and for existing drugs in a new indication)

• Obtaining permission to start a clinical trial
• Submission to an ethics committee 
• Discussion of country-specific differences
• Interactive sharing of experiences

Workshop/working in smaller groups

12:15–13.00

Lunch

All

13:00–14:00
60 minutes

S3-b Practical exercise: setting up a clinical trial (continued)
(for new drugs and for existing drugs in a new indication)

• Obtaining permission to start a clinical trial
• Submission to an ethics committee 
• Discussion of country-specific differences
• Interactive sharing of experiences

Workshop/working in smaller groups

14:00–14:30
30 minutes

S4 Managing investigational medicinal products

• Labelling
• Storage
• The role of the Qualified Person (QP)

• 25-minute lecture
• 5-minute moderated discussion

14:30–15:15
45 minutes

S5 Pharmacovigilance requirements

• Pharmacovigilance and adverse-event reporting
• Safety reporting definitions and requirements
• Reporting requirements for suspected unexpected serious adverse reactions (SUSARs), adverse events, and adverse reactions

Including refreshments in the room

• 30-minute lecture
• 15 minutes working in groups

15:15–15:45
30 minutes

S6: Legal aspects of clinical trials

• Insurance
• Liability
• Contracts
• Study site findings

• 20-minute lecture
• 10 minutes working in groups

15:45–16:30
45 minutes

S7: Latest developments: GDPR (May 2018)
in the context of clinical trials

• Overview of General Data Protection Regulation (GDPR) key requirements
• Transparency and patient information
• Data breaches  

• 35-minute lecture
• 10 minutes working in groups

16:30

Summary and close

All