Canadian LC-MS group: Bioanalysis Conference

In continuation of 2007 and 2008 workshops, the 3rd Workshop on Recent Issues in Regulated Bioanalysis (Montreal April 16-17, 2009) will address both new issues and follow-ups on the progress of the resolutions that are agreed upon last year in the field of GLP Bioanalysis.

Detailed information of this must attend event for those in Bioanalysis and Pharmacokinetics can be found at http://www.canadianlcmsgroup.com/bioanalysis_glp_events.php.

What is New and Why Your Attendance is Important?

Updates on ISR:

• Dr. Brian Booth from FDA will update us on FDA's Experience after 1 year of ISR data, and current status of FDA guidance.
• Dr. Stephen Lowes from Advion will explain you how to perform a scientific Investigations in the event of ISR failure. What kind of action is required if ISR values do not agree with the original assay result?
• We will verify if what discussed and agreed upon last year on Incurred Sample Reanalysis (ISR) has been put in place.
• We will evaluate how the industry is dealing with the new FDA recommendations of using more than 20 samples for ISR.
• We will assess the data and experience that the industry has acquired after one year of performing ISR data by considering regulatory requirement vs. good science.

New EMEA Guidance and Guidelines:

• Based on last year's feedbacks, Louise Mawer from MHRA has been invited this year to update us on new EMEA Bioequivalence Guidance.
• You will also receive an update on the 'Concept Paper/Recommendations on the Need for a (CHMP) Guideline on the Validation of Bioanalytical Methods' that the EMEA has recently published.

Challenges in Bioanalysis:

• Dr. Patrick Vallano from Mylan will talk about the assessment of processed sample stability.
• Dr. Mario Rocci from Prevalere will present the challenges with bioanalytical method development, qualification & transfer.
• Dr. Rupinder Phull from Barr Laboratories will explain you the multiple difficulties and challenges involved in the bioanalysis of endogenous drugs.
• Dr. Douglas M. Fast from Pfizer will update the latest news, perspectives and suggestions for performing a modernizations on USA GLP .
• Dr. Saleh Hussain will update you about the most recent data on how unstable metabolites can impact bianalytical assay performance.
• Michael Lindsay from Apotex will lecture about the impact of concomitant medications on method specificity (To be confirmed).
• You will gain practical advice from opinion leaders on how to cope with Acetonitrile (ACN) Worldwide shortage.

Foreign Submissions to Canadian Authorities:

• With a growing number of submissions from foreign companies to Canadian authority, Eric Ormsby from Health Canada TPD will talk about the most common issues found in foreign submissions and TPD recommendations.

Instruments/Techniques that Can Improve Quality in Regulated Bioanalysis:

• Myth or Reality? Industry experience on the latest bioanalytical technique available will be discussed.
• You will Increase your knowledge on UPLC, FAIMS, MS3, HRES, etc. and you will find out what will be available for the future.

When and How Much 'Anomalous Results' Need to be Investigated?

• We will hear from authorities in the field and we will share opinions and experiences about acceptation vs. rejection of evaluations/batches that meet acceptance criteria but scientifically disputable.
• How regulatory agencies 'feel' about the rejection of data that meet acceptance criteria borderline?

New or Emerging Guidelines on Method Development and Validation:

• You will hear about the most recent industry standards and regulatory agencies perspective on which extra tests performed during method development should be re-performed during the validation.
  - Hemolysis testing
  - Metabolite testing
  - OTC metabolites
  -Variable injection volumes
  - Cross-validation between different anticoagulant salt forms.

A 2-level 2-half-day Pre-Workshop short course on “Issues in Regulated Bioanalysis: Challenges Solutions and Applications in Bioanalytical Method Validation and Sample Analysis” has been specifically designed to be offered on April 15th to prepare the attendees to fully benefit from this workshop.

For Event Details including Registration Details and Online Registration, please visit http://www.canadianlcmsgroup.com/bioanalysis_glp_events.php .