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Contact Us
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Sunday, November 11

8:30 am – 4:00 pm

• CMC Challenges and Opportunities in Product Development and Registration

Short Course

Monday, November 12

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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

• Risk-based CMC Review and Quality Assessment
  

symposium

5:00 pm – 6:00 pm

• AAPS Regulatory Sciences (RS) Section Membership Meeting

6:15 pm – 7:15 pm

• AAPS Regulatory Sciences (RS) Section Reception

Tuesday, November 13

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7:00 am – 8:15 am

• Metabolic and Transporter Drug Interactions: Design and Conduct of Preclinical and Clinical Studies

Tuesday Sunrise Sessions are Funded by a Grant from

Sunrise Session

8:30 am – 11:00 am

• Development and Regulatory Challenges for Drug-Device Combination Products

symposium

9:00 am – 11:00 am

• Clinical and CMC Regulatory Considerations in Pediatric Drug Development

Roundtable

2:00 pm – 4:00 pm

• Challenges and Opportunities for Implementation of Quality by Design (QbD)

Roundtable

2:00 pm – 4:30 pm

• Current Issues and Advances in the Determination of Bioequivalence

Tuesday Afternoon Symposia are Funded by a Grant from

symposium

Wednesday, November 14

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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
  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 – 4:00 pm

• Science & Regulation of QbD

Roundtable

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.

symposium

2:00 pm – 4:30 pm

• Regulatory Considerations on the Use of Lipid Excipients in Oral and Parenteral Drug Products

Wednesday Afternoon Symposia are Funded by a Grant from

symposium

Thursday, November 15

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7:00 am – 8:15 am

• The Critical Path to Establishing Equivalence of Advanced Dosage Forms
  Thursday Sunrise Sessions are Funded by a Grant from
  

sunrise Session

9:00 am – 11:00 am

• Biosimilar/Biogenerics: Review of Regulatory Pathway

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
  Funded by Grants from
  

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