|08:30 - 09:00||Registration|
|09:00 - 10:00||Welcome coffee|
|10:15 - 11:00||Key Note Speaker|
|11:00 - 13:00||
Clinical Trials Regulation: Key Stakeholders are actively engaged in the
implementation phase; How? and does it affect you?
Good Clinical Practice, the new addendum E6 (R2) is now effective
Risk Based Approaches are becoming the norm! Where do we stand and
how the future may look like?
Operating Models further re-defined by new regulations & guidelines!
Will new specifications (TMF, eSources, Data Privacy..) facilitate implementation & compliance?
|18:30||Closure of Day 1|
|08:30 - 10:30||
e-systems and Technical Solutions
Perspective of the GCP inspectors!
Clinical Trials in Paediatric population
New regulatory trends and practices!
|10:30 - 11:00||Coffee Break|
|11:00 - 12:30||
European Medical Device Regulation
Experts' insight and views!
Data Privacy Regulation in Clinical Research
Protecting personal data: the “HOW TO”?
|13:30 - 15:30||
Will there still be any hurdles on the pathways as we move to the future?
|15:30 - 16:00||Brexit: Everything that you want & NEED to know!|
|16:00||Eucrof Closing Message, end of the conference|
Please note the programme is preliminary and it may be subject to change.