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Workshop

Small-Molecule Bioanalytical Method Validation & Regulated Bioanalysis: Fundamentals, the New FDA Guidance and Regulatory Trends


Speakers: Mark Rose, CHDI; David Humphries, Covance; Kristen Harman, ChemoCentryx; David Scharberg, Pharmaceutical Outsource Solutions; Steve Lowes, Q2 Solutions; Eric Woolf, Merck; Deqing Xiao, Gilead
Organizers: Thomas Tarnowski, Gilead; Kristen Harman, ChemoCentryx
Date: 2019-10-03
Time: 8:45-17:00 Pacific Time
Registration fee (USD): Regular: $195; Academic: $125; For unemployed or students: $30; For vendor-show rep: $35; For major-sponsor rep (incl lunch): $0
Location: SF Bay Area: Foster City Crowne Plaza
Major Sponsor: (3)Alturas Analytics; Eurofins Bioanalytical Services; WORLDWIDE CLINICAL TRIALS
Vendor show vendors registered to date: (5)AB Sciex; Intertek; Lovelace Biomedical; MicroConstants; Q2 Solutions
Registration: http://www.PBSS.org
Registration deadline:2019-10-03  (it will close sooner if the seating cap is reached)

About the Topic

Regulated bioanalysis (RBA) is required in the key parts of drug development that involve evaluations of drug safety, bioequivalence, and pharmacokinetics, and RBA data quality directly impacts the reliability of such assessments. RBA Method Validation requires compliance with various national method validation guidances, which will soon be superseded by harmonized guidance from the International Conference on Harmonisation (ICH). To ensure successful assay applications and regulatory submissions, bioanalytical methods are extensively evaluated and validated for accuracy/precision, selectivity, specificity, sensitivity, recovery, and stability under various operational conditions. Data generated for validation and sample analyses and all documentation necessary for reconstructing the validation study and sample analyses, (e.g. experimental data, protocols, reports, staff training records, SOPs, etc.) needs to be maintained and available for data audit and inspection.

Presenters at this workshop are internationally recognized experts on RBA and regularly present at international bioanalytical conferences. The workshop includes a general introduction to regulated bioanalytical method development/validation and sample analysis, as well as presentations of things to consider when partnering with a bioanalytical contract research organization (CRO) to perform such work. Presenters will also cover how to comply with the guidances and regulations, and discuss recent topics relating to the newest FDA Bioanalytical Method Validation guidance and the draft ICH guidance.

Workshop Agenda:

  1. Regulated bioanalysis: fundamentals, function setup, Bioanalytical Method Validation (Mark Rose, CHDI)
  1. Recommendations for working successfully with bioanalytical contract organizations
    1. CRO perspective (David Humphries, Covance)
    2. Pharma /Sponsor Perspective; (Kristen Harman, ChemoCentryx)
  1. Ensuring adequate quality and compliance in bioanalytical work (David Scharberg, Pharmaceutical Outsource Solutions)
  1. Highlights from the 2018 FDA Bioanalytical Method Validation Guidance, changes from previous guidance, future global harmonized guidance (Steve Lowes, Q Squared Solutions; Eric Woolf, Merck)
  1. Application of RBA principles to drugs in cells and tissues (Deqing Xiao, Gilead)


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2019-09-13, Biotransformation and Disposition of Larger Molecules: Peptides, Nucleotides, Proteins, mAbs, and ADCs
2019-10-18, Physiologically Based Pharmacokinetic (PBPK) Modeling: Fundamentals, Regulatory Guidance & Applications
2019-11-12, Antibody Drug Discovery and Development: Hit Generation, Engineering, Cell-line Development, IND enabling studies, and Biosimilars
2019-12-10, In vitro Diagnostics and Precision Medicine
2020-02-11, Drug-Device Combination
┬ęPharmaceutical & BioScience Society, International; Last Modified: 6/26/2019; Visited: 1005; Admin Logon
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