Customer Event Berlin

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

5 March 2024

Agenda

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

9:30–12:30

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

13:30–15:00 (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: 15:15–15:45

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.

Venue

Humboldt Universität
Spandauer Str. 1, 10178 Berlin, Germany

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Select workshop you would like to attend Workshop 1: Nitrosamines ImpuritiesWorkshop 2: Impurities – Perspectives of pharma Industry and how USP supportsWorkshop 3: New Reference Material category- ARM (Analytical Reference Material)Workshop 4: Complex Injectables (Hybrid with US)

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