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Sunday, November 11

8:30 am - 4:00 pm

• Challenges and Opportunities in Developing Drug Substance and Product CMC Dossiers: CTD Submissions

Short Course

8:30 am – 4:00 pm

• Monitoring Impurities in Pharmaceuticals

Short Course

8:30 am - 4:00 pm

Recent Advances in HPLC and Related Chromatographic Procedures – Application in Small vs. Large Molecules; Cross-fertilization Between Bioanalytical and Pharmaceutical Analysis Disciplines

Short Course

Monday, November 12

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8:00 am – 10:00 am

• Functionality Testing of Excipients

Monday Morning Roundtable Funded by a Grant from

Roundtable

8:00 am – 10:00 am

• Selection of Efficient Cleaning Validation Strategies

  
  

Mini Symposium

2:00 pm – 4:00 pm

• Preparedness for Question Based Review in Drug Approval – Role of Analytical Chemist

Roundtable

2:00 pm – 4:30 pm

• In Vitro Release Testing of Dosage Forms Based on Novel Technologies: Developments and Challenges
  

SYMPOSIUM

5:10 pm – 6:10 pm

• AAPS Analysis and Pharmaceutical Quality (APQ) Section Membership Meeting

6:30 pm – 7:30 pm

• AAPS Analysis and Pharmaceutical Quality (APQ) Section Reception

Tuesday, November 13

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7:00 am - 8:15 am

• Dissolution Method Validation and Method Transfer

Tuesday Sunrise Sessions are funded by a Grant from

Sunrise Session

8:30 am – 11:00

• AAPS Graduate Student Symposium in Analysis and Pharmaceutical Quality and the APQ Research Achievement Award Winner Lecture

9:00 am – 11:00 am

• Formulation and Stability of Nutraceuticals

Roundtable

9:00 am – 11:00 am

• Variability of Ligand Binding Assays Used for PK Protein Drug Bioanalysis – Database Collected as a Follow-up to the 2006 AAPS Crystal City III Workshop

Roundtable

2:00 pm – 4:00 pm

• The Value of Domestic and International Outsourcing

Roundtable

2:00 pm – 4:30 pm

• Determination of In Vivo In Vitro Correlations (IVIVC) for Sustained Release (SR) Parenterals (Depo Formulations)

Tuesday Afternoon Symposia are Funded by a Grant from

Symposium

Wednesday, November 14

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7:00 am – 8:15 am

• Evaluation of Selectivity and Specificity of a Ligand Binding Assay for Macromolecules: An Underestimated Challenge

Sunrise Session

7:00 am – 8:15 am

• Regulatory Relief from PAT and Quality by Design: Does it Truly Exist?

Sunrise Session

8:30 am – 11:00 am

• Evolution of Analytical Methods from Pre-clinical Phase Through Registration-Ensuring Method Performance and Regulatory Compliance (APQ)
  Wednesday Morning Symposia are Funded by a Grant from
  

Symposium

9:00 am – 11:00 am

• Cost-effective Stability Program to Support Global Supply Chain of Drug Products

Roundtable

9:00 am – 11:00 am

• Impact of Quality by Design on Pharmaceutical and Analytical Development

Roundtable

2:00 pm – 4:30 pm

• Advances in Analytical Techniques for Preformulation Support in Pharmaceutical R&D

Wednesday Afternoon Symposia are Funded by a Grant from

Symposium

2:00 pm – 4:30 pm

• Clinical Supplies and Their Stability Evaluation – Scientific Insights for Drug Development and Regulatory Expectations in U.S. and E.U.

Wednesday Afternoon Symposia are Funded by a Grant from

Symposium

Thursday, November 15

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7:00 am – 8:15 am

• Practical LC-MS/MS Method Development Supporting the Drug Development Process
  Thursday Sunrise Sessions are Funded by a Grant from
  

Sunrise session

8:30 am – 11:00 am

• Biomarkers and Metabolic Profiles; Microdialysis Sampling and Analytical Frontiers in Tissue Targeted Metabonomics

Symposium

8:30 am – 11:00 am

• Validation of Non-chromatographic Methods (NIRA, Bioanalysis and Particle Size Analysis)

Symposium

9:00 am – 11:00 am

• Emerging Pharmaceutical Markets: Are We Afraid of Outsourcing Yet?

Roundtable

1:30 pm – 5:00 pm

• RS/APQ Open Forum
  Clinical Trial Materials – Clinical and CMC Challenges for Successful Conduct of Multi-Regional Clinical Trials

1:30 pm – 5:00 pm

• APQ Open Forum
  Analytical Instrument Qualification: An Update and Current Industry Trend
  Funded by Grants from
  
  
  
  

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