Focus Workshop Slides 2017 September
Program of EBF Workshop “Experimental data as the cornerstone for a science driven bioanalytical guideline” September 24-26, 2017
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.
Program
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 | |||
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 | |||
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 (not released) | |||
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) |