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

2. Lynda Paleshnuik | May 2014 2 Schedule of talks Day 1 Prequalification: Overview and update Bioequivalence WHOPARs and labeling Quality assessment principles: Part I API assessment: impurities Specifications

3. Lynda Paleshnuik | May 2014 3 Schedule of talks Day 2 Packaging Quality assessment principles: Part II Pharmaceutical development Process validation Stability assessment: API and FPP Collaborative procedure

4. Lynda Paleshnuik | May 2014 4 Schedule of talks Day 3 Assessing batch records GMP issues in quality assessment

5. Lynda Paleshnuik | May 2014 5 Your participation 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

6. Lynda Paleshnuik | May 2014 6 Questions 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

7. Lynda Paleshnuik | May 2014 7 Your participation Day 3 Fill out the workshop evaluation (Very important) One-on-one breakout sessions (feedback and guidance)

8. Lynda Paleshnuik | May 2014 8 Your participation Day 4 Written exam Workshop wrap-up and final close

9. Lynda Paleshnuik | May 2014 9 CTD Common technical document

10. Lynda Paleshnuik | May 2014 10 Acronyms! 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

11. Lynda Paleshnuik | May 2014 11 Acronyms! 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

12. Lynda Paleshnuik | May 2014 12 Acronyms! SST - system suitability testing TRS – WHO technical report series publication WHOPAR – WHO public assessment report

13. Lynda Paleshnuik | May 2014 56 Questions?