Customer Event Berlin

Quality: Critical Element For Assuring Access To Safe And Effective Drugs

5 March 2024


  • 08:30–09:30 - Sign in and welcome coffee
  • 09:30–12:30 - Seminar (Plenary session)
  • 12:30–13:30 - Lunch
  • 13:30–15:00 - Workshops (4 Groups)
  • 15:15–15:45 - Seminar (Plenary session)
  • 16:00 - Adjourn


Welcome and Introduction Alessandro Slama PhD, Vice President, Regional Program Operations, General Manager, USP EMEA
USP General Overview Benoit Rime, Strategic Customer Development Senior Manager, USP EMEA
How to avoid measurement uncertainty and potential risk of noncompliance?
USP Comprehensive solutions: Pharmacopeial Standards and Pharmaceutical Analytical Impurities
Christian Zeine PhD, Scientific Affairs Senior Manager, USP EMEA
Nitrosamine impurities, current requirements and challenges for the off-patent industry Alexandra Vaz, Policy Officer, Medicines for Europe

13:3015:00 (Each attendee to select his/her workshop of choice)

Workshop 1: Nitrosamines Impurities
  • Nitrosamines risk assessment / case study
  • Nitrosamines limits definitions / CPCA Framework
  • USP Nitrosamines resources and tools
  • Testing Methods and Analytical Challenges
  • Related Q&A
Amanda Guiraldelli Mahr, Scientific Affairs Senior manager, USP EMEA
Workshop 2: Impurities – Perspectives of pharma Industry and how USP supports
  • GC <477> User-determined reporting thresholds: What to expect!
  • Impurities in excipients: USP tools, FDA’s thinking, stakeholders’ experiences
  • Impurity testing: Two-table approach in drug product monographs
  • Related Q&A
Christian Zeine PhD, Scientific Affairs Senior Manager, USP EMEA
Workshop 3: New Reference Material category- ARM (Analytical Reference Material)
  • Case study and applications in mAbs analytical characterization
  • ARMs for Biologics: Impurities and gDNA- How can they complement the biopharma manufacturing life cycle!
Nikhil Rautela, Scientific Affairs Senior Manager, USP EMEA
Workshop 4: Complex Injectables (Hybrid with US)
  • Technical and Regulatory challenges in developing Complex Injectables (Microspheres, Liposomes, Iron colloidal products, Nanosuspensions and in situ forming implants).
Prabhakar Gruddanti, Senior Principal Scientist, General Chapter, USP

Closing Seminar: 15:1515:45

  • Each Breakout session to present key takeaways to the whole group

Note: The agenda is subject to change. If there are any changes, we will announce them via email. 


Humboldt Universität
Spandauer Str. 1, 10178 Berlin, Germany


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