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Copenhagen Workshop May 2014

Copenhagen Workshop May 2014. Session outlines and objectives L. Paleshnuik Lead Quality Assessor PQ T. 1. Day 1 • Prequalification: Overview and update • Bioequivalence • WHOPARs and labeling • Quality assessment principles: Part I • API assessment: impurities • Specifications.

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Copenhagen Workshop May 2014

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  1. Copenhagen Workshop May 2014 Session outlines and objectives L. Paleshnuik Lead Quality Assessor PQT • 1

  2. Day 1 • Prequalification: Overview and update • Bioequivalence • WHOPARs and labeling • Quality assessment principles: Part I • API assessment: impurities • Specifications Schedule of talks 2

  3. Day 2 • Packaging • Quality assessment principles: Part II • Pharmaceutical development • Process validation • Stability assessment: API and FPP • Collaborative procedure Schedule of talks 3

  4. Day 3 • Assessing batch records • GMP issues in quality assessment Schedule of talks 4

  5. Days 1 and 2 • Open discussion/Q&A on the day’s topics • Participate in the exercises/discussions • Ask questions during/after talks or at the end of the day, • Collect questions for your one-on-one session Your participation 5

  6. Questions are good • The speaker will say if questions should be held for the end of their talk • Please speak slowly when posing Qs • Questions can be given to any of the facilitators, to be handled at end of day • A speaker may defer a complex question Questions 6

  7. Day 3 • Fill out the workshop evaluation (Very important) • One-on-one breakout sessions (feedback and guidance) Your participation 7

  8. Day 4 • Written exam • Workshop wrap-up and final close Your participation 8

  9. Common technical document CTD 9

  10. API – active pharmaceutical ingredient BCS – biopharmaceutics classification system COA - certificate of analysis CTD – common technical document EC – enteric coated ER – extended release FDC – fixed dose combination FPP – finished pharmaceutical product GC – gas chromatography Acronyms! 10

  11. ICH – international conference on harmonization NMRA – national medicines regulatory authority PhInt – International Pharmacopoeia PQ/PQT – Prequalification of Medicines Team PSD – particle size distribution QA – quality assurance QRM – quality risk management SPC/SmPC – summary of product characteristics Acronyms! 11

  12. SST - system suitability testing TRS – WHO technical report series publication WHOPAR – WHO public assessment report Acronyms! 12

  13. Questions? Questions? • 56

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