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Day 0 - 30 NOVEMBER 2010 |
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14:00 |
20:00 |
Registration and Information Desk Open |
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Day 1 - 1 DECEMBER 2010 |
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07.00 |
18:00 |
Registration and Information Desk Open |
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MORNING PLENARY SESSIONS |
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08.30 |
08.40 |
Welcome and opening remarks |
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08.40 |
10.00 |
Bioanalysis – Thinking Outside the ”Commodity” Box |
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08.40 |
09.00 |
Ian Wilson (AstraZeneca) |
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What You Can’t See Can Hurt You: Looking at Bioanalysis by LC-MS From the Outside |
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09.00 |
09.20 |
John Pugh (University of Sheffield) |
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Elemental imaging via LA-ICP-MS - New oppertunities in the life sciences |
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09.20 |
09.40 |
Robert Plumb (Waters) |
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High Sensitivity Analysis of Biotherapeutics Using Capillary LC |
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09.40 |
10.00 |
Martyn Hemsley (Covance) |
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Considerations and Experiences in Developing Bioanalytical Assays for the Quantitative Determination of Oligonucleotides |
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10.00 |
10.30 |
Coffee Break |
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10.30 |
12.30 |
Practical Solutions to Bioanalytical Challenges : Blood - the original bioanalytical matrix? |
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10.30 |
11.00 |
Keynote Speaker : Albert Wolthuis (KCL) |
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The Blood Matrix: A Dynamic Mirror |
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11.00 |
11.20 |
Achiel Van Peer (Janssen Research and Development) |
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Blood and Plasma: "A Magic Twin or Single in Human Pharmacokinetics ?" |
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11.20 |
11.35 |
John Perkins (Advion BioServices) |
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Long Term Stability Issues Observed during Validation of an LC-MS/MS assay for Clopidogrel and Metabolites |
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11.35 |
11.50 |
Ronald de Vries (Janssen Research and Development) |
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Analyte Instability Issues in Blood |
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11.50 |
12.10 |
Achim Freisleben (Merck-Serono for EBF) |
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EBF Current Thinking on the Conduct of Whole Blood Stability |
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12.10 |
12.30 |
Panel Discussion |
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12.30 |
13.30 |
Lunch and poster session |
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Day 1 - 1 DECEMBER 2010 |
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AFTERNOON PLENARY SESSIONS |
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13.30 |
16.00 |
Towards Global Harmonization |
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13.30 |
13.50 |
Philip Timmerman (Janssen Research and Development for EBF and GBC) |
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GBC-Harmonization Initiative and EBF Perspective |
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13.50 |
14.10 |
Jérôme Barré (afssaps) |
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EMA Perspective on Global Harmonization |
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14.10 |
14.30 |
Rafael Barrientos (Magabi for ACBio) |
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South America perspective |
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14.30 |
14.50 |
Daniel Tang (Frontage for BBDS and SBDS) |
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APAC Perspective on Global Harmonization |
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14.50 |
15.10 |
Mark Arnold (Bristol Meyers Squibb for AAPS) |
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AAPS Perspective on Global Harmonization |
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15.10 |
15.30 |
C.T. Viswanthan (FDA/CDER) |
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FDA Perspective on Global Harmonization |
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15.30 |
16.00 |
Panel Discussion |
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16.00 |
16.30 |
Coffee Break |
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16.30 |
18.00 |
Pt Sponsor session I |
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16.30 |
17.00 |
Gary Harland (Waters) |
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Addressing The Challenge of Sensitivity and Metabolite Detection in Bioanalytical Studies |
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17.00 |
17.30 |
Mauro Aiello (AB SCIEX) |
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Overcoming the Data Analysis Bottleneck with Next Generation Quantitative Software |
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17.30 |
18.00 |
Pat Bennett (Thermo Scientific) |
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Future of the Triple Quadrupole: What is Possible and what is Practical? |
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18.30 |
20.00 |
Conference Reception I |
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Discover Catalunyan Reds : Enjoy a Few Drinks and Savor Traditional Food During this Great Networking Opportunity |
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Day 2 - 2 DECEMBER 2010 |
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07.00 |
18:00 |
Registration and Information Desk Open |
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MORNING PLENARY SESSIONS |
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08.30 |
10.00 |
Pt Sponsor session II |
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08.30 |
09.00 |
Lester Taylor (Agilent) |
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Use of an Ion Funnel Triple Quadrupole LC/MS Instrument for HighSensitivity Quantitation. |
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09.00 |
09.30 |
Martin Nemansky (PRA International) |
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Comparison of various platforms for large molecule analysis - Introduction of the Imperacer® technology |
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09.30 |
10.00 |
Iain Shaw (Quotient Bioresearch) |
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C14 enabled drug development |
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10.00 |
10.30 |
Coffee Break |
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10.30 |
12.30 |
Technologies and Comparison of Assay Platforms |
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10.30 |
10.50 |
Stefanie Fischmann (Abbott) |
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Comparison of Data from ECL and Hyphenated LC-MS Platforms on Quantitation of mAb from Serum Samples |
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10.50 |
11.10 |
Fritz Poulsen (NovoNordisk) |
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Wash AlphaLISA - An Extension of the AlphaLISA/LOCI Technology |
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11.10 |
11.30 |
Ronald Schmidt (Sanofi-Aventis) |
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Quantitative LC-MS/MS Analysis of Synthetic Insulins |
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11.30 |
11.50 |
Craig Stovold (Quotient Bioresearch) |
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Appliation of the Gyrolab to bioanalytical, pharmacodynamic and immunogenicity analysis in a regulated laboratory |
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11.50 |
12.10 |
Birgit Jaitner (Novartis) |
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An approach to measure total drug levels in human serum samples while overcoming target interference |
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12.10 |
12.30 |
Panel Discussion |
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12.30 |
14.00 |
Lunch and Poster Session |
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Day 2 - 2 DECEMBER 2010 |
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AFTERNOON BREAKOUT SESSIONS |
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14.00 |
15.30 |
Ia - Reconnect on Dried Blood Spots |
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14.00 |
14.30 |
Philip Timmerman (Janssen Research and Development for EBF and GBC) |
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EBF recommendation on Method Validation for Dried Blood Spots |
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14.30 |
14.50 |
Julian Haynes (Pfizer) |
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Application of a Simple 2D-LC-MS/MS System to Control Ion Suppression Effects from DBS Samples |
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14.50 |
15.10 |
Rohan Takur (Taylor Technology) |
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DBS and HRMS for in vivo Fast PK studies – The Value and Advantage for Pre-Clinical Studies. |
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15.10 |
15.30 |
Panel Discussion |
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14.00 |
15.30 |
Ib - FDA Draft Guideline on "Assay Development for Immunogenicity Testing of Therapeutic Proteins" and Related Topics |
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14.00 |
14.20 |
Susan Kirshner (FDA) |
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US FDA Draft Guidance on Immunogenicity Testing |
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14.20 |
14.40 |
Arjen Companjen (Crucell for EBF) |
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The EBF Perspective on the FDA draft guidance on Assay Development for Immunogenicity Testing of Therapeutic Proteins |
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14.40 |
15.00 |
Robin Thorpe (NIBSC) |
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European Guidance on Unwanted Immunogenicity of Biologicals |
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15.00 |
15.30 |
Panel Discussion |
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15.30 |
16.00 |
Coffee Break |
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16.00 |
18.00 |
IIa - Continuation from Break Out Session 14.00-15.30 on Immunogenicity Guideline and Related Topics |
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16.00 |
16.30 |
Geoff Hale (Merck/Millipore) |
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The untility and futility of cut points for assessing unwanted immunogenicity |
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16.30 |
17.00 |
Janka Ryding (Ferring) |
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Case Study: Neutralization Assay Design and Qualification. |
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17.00 |
17.30 |
Andrea Kiessling (Novartis) |
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Integrated Approach of PK/PD/Immunogenicity Analysis |
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17:30 |
18:00 |
Panel Discussion |
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16.00 |
18.00 |
IIb - Practical Solutions to Bioanalytical Challenges : Matrix Effects |
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16.00 |
16.30 |
Keynote Speaker : Vincenzo Pucci (Merck & Co Inc) |
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Strategies for Reducing Phospholipid-based Matrix Effects in LC-ESI-MS Bioanalysis |
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16.30 |
16.50 |
Curtis Sheldon (Celerion) |
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Haemolysed Sample Evaluation : A Variety of Issues for a Variety of Situations |
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16.50 |
17.10 |
Carl-Johan Sennbro (Active Biotech for EBF) |
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Choice of Anticoagulant and Comparison of Counter-Ions - Results from Two EBF Surveys |
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17.10 |
17.25 |
Tom Verhaeghe (Janssen Research and Development) |
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Matrix Effects in Practice : Sense and Nonsense of Internal Standard Response Acceptance Criteria |
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17.25 |
17.40 |
Magnus Knutsson (Ferring) |
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Experiences of Assessing Matrix Effects by Monitoring Internal Standard Response in Study Samples |
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17.40 |
18.00 |
Panel Discussion |
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18.30 |
20.00 |
Conference Reception II |
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The Catalunya Cava Experience: Enjoy a Few Drinks and Savor Traditional Food During this Great Networking Opportunity |
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Day 3 - 3 DECEMBER 2010 |
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MORNING PLENARY SESSIONS |
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8.30 |
10.30 |
Finding the Right Level |
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8.30 |
8.40 |
Margarete Brudny-Kloeppel (Bayer Schering Pharma AG for EBF) |
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Introduction |
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8.40 |
9.10 |
Fabio Garofolo (Algorithme Pharma Inc.) |
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When and How Much do Anomalous Results Need to be Investigated? |
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9.10 |
9.40 |
Silke Lüdtke (Boehringer-Ingelheim for EBF) |
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Handling of Anomalous Results in Europe – Feedback from EBF Survey |
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9.40 |
10.10 |
EBF speaker(s) to be announced |
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Case Studies |
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10.10 |
10.30 |
Panel Discussion |
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10.30 |
11.00 |
Coffee Break |
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11.00 |
12.00 |
EBF Feedback |
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11.00 |
11.30 |
Peter van Amsterdam (Abbott for EBF) |
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Update on New Organization |
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11.30 |
12.00 |
Margarete Brudny-Kloeppel (Bayer Schering Pharma AG for EBF) |
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Feedback from EBF 2010 Surveys and Activities |
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12.00 |
13.40 |
Biomarkers |
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12.00 |
12.20 |
Liesbeth Vereyken (Janssen Research and Development) |
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Challenges with Nucleoside Triphospate Method Development and Analysis during the Life Cycle of a HCV Program |
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12.20 |
12.40 |
Mark Spengler (Chimera) |
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Using Ligang-Binding Assay Sensitivity for Improved Matrix Tolerance and Related Parameters by Tailored Sample Dilution. |
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12.40 |
13.00 |
Anna Valeri (MHRA) |
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Title to be Confirmed |
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13.00 |
13.20 |
Jan Moack (Slovak University of Technology, Bratislava) |
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Effective use of Combination of Lung Malignity Marker |
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13.20 |
13.45 |
Panel Discussion |
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13.45 |
14.00 |
Close out Discussion, Ideas for 2011 |
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14.00 |
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Adjourn |
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