Before the first clinical trial in humans (First-in-Human)

Before the first clinical trial in humans (First-in-Human)
Before the first clinical trial in humans (First-in-Human, FIH), there are many activities that need to be in place. During the evening, we will go through what is needed for CMC development for drugs and important factors when choosing a CDMO. What are the pre-clinical aspects that need to be documented in the form of in vitro, in vivo studies and safety studies. For medical devices, design control, risk analysis and pre-clinical tests are discussed. We also get to hear some news about TOPRA. You will have the opportunity to meet colleagues in a relaxed and pleasant environment. The meeting is open to everyone who works with and is interested in regulatory affairs.




Brought to you by the TOPRA IN Sweden Steering Group

Date:  16 September 2026
Time: 18:00 - 21:00
Location: Medicon Village (Room: Sharience), Scheeletorget 1, 223 63 Lund, Sweden
Please note this presentation will be delivered in Swedish

Meeting Agenda

Time Details
 18:00 - 18:30 The evening begins with light refreshments
 18:30 - 18:35 Welcome
Speaker: Ruxandra Ionescu, TOPRA Volunteer
 18:35 – 19:05 CMC drug development for FIH
     •  DS and DP development
     •  CDMO selection
     •  Experiences and tips
Speaker: Ruxandra Ionescu, ProPharma group 
 19:05 – 19:35 Pre-clinical studies before FIH for drugs
     •  In vitro and In vivo studies
     •  Safety studies
     •  Experience
Speaker: Karin von Wachenfeldt, Truly Labs 
 19:35 - 19:50 Break
 19:50 – 20:20 Medical devices before clinical trials
     •  Design control and risk analysis
     •  Manufacturing and quality systems
     •  Pre-clinical testing
     •  Experience
Speaker: Marie Grey, Moroxite
 20:20 - 20:35 TOPRA news
Speaker: Margareth Jorvid, Chair TOPRA IN Sweden            
20:35 - 21:00
 Q & A
 



 

Pricing

 Standard fees
 Registration Type Price (GBP)
 Standard Price 
 TOPRA Member's or MPA employee's		 FREE
 Standard Price
 Non-member		 £60.00




 
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When
16/09/2026
Where
Medicon Village Scheeletorget 1 223 63 Lund LUND SWEDEN
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