EBF
EBF Focus
Focus201709

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  

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Monday: 25 September 2017
Unless otherwise indicated, all presenters will be presenting on behalf of the EBF
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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
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10:30 11:00 Coffee break
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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
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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
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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
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Tuesday: 26 September 2017
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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)
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10:30 11:00 Coffee Break
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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
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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
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10:30 11:00 Coffee break
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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
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12:30 13:30 Lunch
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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)
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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)
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15:00 15:30 Coffee break
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15:30 16:30 Summary of meeting and closing discussions
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16:30  17:00 Next steps and adjourn (17:00)