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Preliminary Programme

Monday 26 February

08:30 - 09:00 Registration
09:00 - 10:00 Welcome coffee
10:00 Conference Opening
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?
13:00 Lunch
14:30-16.30 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?
16:30-17:00 Coffee break
17:00-18.30 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
20:00 Social event

 

Tuesday 27 February

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”?
12:30 Lunch
13:30 - 15:30 Post-approval Considerations: 
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
16:10 Goodbye Coffee


Please note the programme is preliminary and it may be subject to change.

 

   
 
 
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