EBF
EBF Focus
Focus

EBF - Trainingday:

Critical Reagents for LBA

EBF - Focus Workshop:

New Modalities and Novel Concepts in Bioanalysis
The Altis Grand Hotel
Lisbon, Portugal
14 May 2018
- Training day
15-16 May 2018
- Focus Workshop

Program Training day

draft agenda v06FEB2018

Critical reagents for LBA

14 May 2018, The Altis Grand Hotel, Lisbon, Portugal

The EBF acknowledges the CR experts from the AAPS LBABFG for their contribution to the meeting.

13 MAY 2018  
17:00 Registration desk opens
18:00 – 19:00 Welcome reception – Altis Hotel
 .  
14 MAY 2018  
07:30 Registration desk opens
08:45 – 09:00 Welcome and introduction – Philip
09:00 – 10:30 Session 1 – Critical reagents for PK assays: general & regulatory framework
09:00 – 09:15 Introduction to the session – Susanne Pihl (on behalf of the EBF)
09:15 – 09:45 Update on the guidelines and current practice in industry
Michaela Golob (on behalf of the EBF)
09:45 – 10:15 The EBF decision tree on CR for PK assays, in perspective of current industry practices
Susanne Pihl (on behalf of the EBF)
10:15 – 10:30 Q&A
10:30 – 11:00 Coffee break & networking
11:00 – 12:30 Session 2 – Case studies on alternative approaches to manage critical reagents (PK assays)
11:00 – 11:20 Case study: title tbd
Presenter tbd
11:20 – 11:40 Characterization of critical reagents – FB from the AAPS LBABFG
Tentative: Jonathan Haulenbeek (BMS, on behalf of the AAPS)
11:40 – 12:00 Case study:  title tbd
Thomas Emrich (Roche)
12:00 – 12:30 Expert panel discussion
.  
12:30 – 13:30 Lunch
13:30 – 15:00 Session 3 – Critical reagents for immunogenicity assays –  general & regulatory framework
13:30 – 13:45 Introduction to the session – Birgit Jaitner (on behalf of the EBF)
13:45 – 14:05 Update on the guidelines and current practice in industry
Jo Goodman (on behalf of the EBF)
14:05 – 14:40 Recommendations on CR for immunogenicity assays, in perspective of current industry practices
Barry van der Strate (on behalf of the EBF)
14:40 – 15:00 Q&A
 .  
15:00 – 15:40 Coffee break & networking
15:40 – 17:15 Session 4 – Case studies on alternatives approaches to manage critical reagents (immunogenicity assays)
15:40 – 16:00 Qualification of new lots of critical reagents for IG assays: Some practical examples
Lydia Michaut (Novartis)
16:00 – 16:20 Management of an ADA critical reagent issue during a clinical study support
Laurent Vermet (Sanofi)
16:20 – 16:40 Case study: title tbd
Presenter tbd
16:40 – 17:15 Expert panel discussion
17:15 – 17:30 Closing Questions & Answers session
Panel of presenters answering delegate’s pre-submitted questions
17:30 Adjourn