EBF
EBF Focus
Dialogue

EBF - Focus Workshop:

(In collaboration with the AAPS and JBF)

Industry input into ICH M10:

Experimental data as the cornerstone for a science driven bioanalytical guideline
The Altis Grand Hotel
Lisbon, Portugal
September 24-26, 2017

Slides

PDF renditions of the powerpoint presentations can be viewed and downloaded from this page by clicking the specific point on the program. The program itself can be viewed and downloaded by clicking here  

Monday: 25 September 2017
Unless otherwise indicated, all presenters will be presenting on behalf of the EBF
. . .   .
08:30 10:30 Introduction
08:30 08:45 Welcome, aim of the meeting, the ICH process 
    Philip Timmerman
08:45 09:00 Issues in industry with current Guidance 
    Jo Goodman
09:00 09:20 Regulatory reflections on the BMV Guideline/Guidance harmonization
    Noriko Katori (NIHS) 
09:20 09:40 Take home message from the AAPS/EBF/JBF sister meeting
    Faye Vazvaei (on behalf of the AAPS)
09:40 10:00 What should be the scope of the guideline and why, including discussion on studies, development phases or analytes in or out of scope
    Philip Timmerman 
10:00 10:30 Panel – Intake questions from the audience on meeting expectations
.    
10:30 11:00 Coffee break
.    
11:00 12:30 Plenary session: Accepting and reporting the final result
11:00 11:20 ISR: When why and how?
    Morten Kall 
11:20 11:40 Best practices for reanalysis: from instrument failure to PK outliers
    Joe Stanta 
11:40 12:00 Documentation and reporting: best practices proposed by the GBC
    Tom Verhaeghe (on behalf of the GBC) 
12:00 12:30 Session close out panel discussion
.    
12:30 13:30 Lunch
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13:30 15:30 Plenary Session – Acceptance criteria for PK assays
13:30 13:40 Introduction: Chromatography, LBA or PK assays?   
    Philip Timmerman 
13:40 14:00 ICH M10 Harmonization: JBF point of view for general topics
    Hisanori Hara (Novartis, on behalf of the JBF) 
14:00 14:20 Run acceptance criteria
    Steve White 
14:20 14:40 Cross and partial validation
    Rachel Green 
14:40 15:00 General principles on stability testing – what is a single source?
    Stuart Mc Dougall 
15:00 15:30 Session close out panel discussion
.    
15:30 16:00 Coffee Break
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16:00 18:00 Plenary Session: Areas of common interest and cross-fertilization
16:00 16:15 Requirements for reference standards for NCE
    Amanda Wilson 
16:15 16:30 Challenges and requirements for reference standards for NBE
    Marianne Scheel Fjording 
16:30 16:45 Sense and nonsense of geomean or arithmetic mean discussion
    Peter van Amsterdam 
16:45 17:00 Hemolysed & hyperlipidemic plasma – a real or perceived issue?
    Cecilia Sparr Eskilsson 
17:00 17:15 Temperature stability testing, are both -20 and -70 needed?
    Timothy Sangster 
17:15 18:00 Session close out panel discussion
.    
.    
Tuesday: 26 September 2017
.
08:30 12:30 Breakout Session – Stability testing for Chromatographic assays
08:30 09:00 Plenary Feedback from day 1 and day 1 evening discussions with panellists and presenters
09:00 09:30 Comed stability testing for chromatographic assays
    Magnus Knutsson 
09:30 10:00 Blood stability testing
    Achim Freisleben 
10:00 10:30 ICH M10 Harmonization: JBF point of view for chromatographic assays 
    Hisanori Hara (Novartis, on behalf of the JBF) 
.    
10:30 11:00 Coffee Break
.    
11:00 11:30 Processed sample stability  
    Amanda Wilson 
11:30 12:00 Feedback from the AAPS/EBF/JBF meeting on above topics
    Eric Woolf (on behalf of the AAPS) 
12:00 12:30 Session close out panel discussion
.    
08:30 12:30 Breakout Session – Hot topics in LBA
08:30 09:00 Plenary Feedback from day 1 and day 1 evening discussions with panellists and presenters
09:00 09:30 Selectivity and interference challenges for LBA
    Michaela Golob
09:30 10:00 Dilution linearity/parallelism
    Robert Nelson 
10:00 10:30 Use of surrogate matrices in LBA PK assays
    Marianne Scheel Fjording 
.    
10:30 11:00 Coffee break
.    
11:00 11:30 Critical reagents in LBA
    Susanne Pihl 
11:30 12:00 Feedback from the AAPS/EBF/JBF meeting on above topics
    Heather Myler (on behalf of the AAPS)
12:00 12:30 Session close out panel discussion
.    
12:30 13:30 Lunch
.    
13:30 15:00 Breakout Session – Matrix effects, selectivity and interference testing for  Chromatographic assays
13:30  13:50 Selectivity and interference testing for chromatographic assays
    Magnus Knutsson 
13:50 14:10 The essence of matrix effects for chromatographic assays
    Benno Ingelse 
14:10 14:30 Feedback from the AAPS/EBF/JBF meeting on above topics
    Eric Woolf (on behalf of the AAPS) 
14:30 15:00 Session close out panel discussion + unanswered question from the day 1 intake
    (focus on Chromatography)
.    
13:30 15:00 Breakout Session – Regulatory ambiguities in LBA
13:30 14:00 Single vs duplicate analysis in LBA
    Pascal Delrat/Gerhard Paul
14:00 14:15 What should not be in the guideline? 
    Jo Goodman
14:15 14:30 Feedback from the AAPS/EBF/JBF meeting on above topics
    Heather Myler (on behalf of the AAPS)
14:30 15:00 Session close out panel discussion + unanswered question from the day 1 intake
    (focus on LBA)
.    
15:00 15:30 Coffee break
.    
15:30 16:30 Summary of meeting and closing discussions 
.    
16:30  17:00 Next steps and adjourn (17:00)