Biologics Comparability and Biosimilars: ICH Q5E Protocols, CQAs and Tiered Statistics – Paris, 21–25 Dec 2026
Biologics Comparability and Biosimilars: ICH Q5E Protocols, CQAs and Tiered Statistics runs in Paris from Monday 21 December to Friday 25 December 2026 (1 Week). The fee is 23,500 SAR per participant. The same programme is also scheduled in 7 other cities.
- Dates
- Length
- 1 Week
- Fee per participant
- 23,500 SAR
- Format
- In person, Paris
- Venue
- Right Bank business hotel
- Status
- Open for registration
- Week
- 52 of 2026
- Reference
- 622_18089
This session
21–25 Dec 2026
This Biologics Comparability and Biosimilars: ICH Q5E Protocols, CQAs and Tiered Statistics session in Paris runs from Monday 21 December to Friday 25 December 2026 (week 52, Q4 2026). It is the only date in Paris in 2026, at a fee of 23,500 SAR, the same for each of them. Registration is open for this date. It is held in person at Right Bank business hotel.
When else does it run in Paris?
- 21 – 25 December 2026 This date 23,500 SAR
- 11 – 15 October 2027 23,500 SAR
How do I book this date?
Register online to request your place, or send us a question about this date first.
Reference for this date: 622_18089. Quote it when you contact us.
Before you book, read our cancellation policy.
Let’s talk about your next step.
Questions about this date
When does Biologics Comparability and Biosimilars: ICH Q5E Protocols, CQAs and Tiered Statistics in Paris start and finish?
It starts on Monday 21 December and finishes on Friday 25 December 2026: 1 Week.
How much does Biologics Comparability and Biosimilars: ICH Q5E Protocols, CQAs and Tiered Statistics in Paris cost?
The fee for this date is 23,500 SAR per participant. Please read our cancellation policy before you book.
Is this date held in person or online?
It is held in person in Paris, at Right Bank business hotel.
What does this programme cover?
Biologics comparability decides whether a cell line, site, scale or purification change can reach patients without new clinical studies, yet many change packages arrive with unranked quality attributes, acceptance criteria set after the data and statistics that cannot separate process drift from real difference. This Core Concept course trains CMC, quality, regulatory and process development teams to plan comparability exercises under ICH Q5E principles and to run biosimilar analytical similarity assessments against a reference product. Participants finish with a Comparability Protocol for a case process change.
The programme outline covers:
- Introduction
- Course Objectives
- Target Audience
- Course Outline
- Day 1: Biologics Variability and the Comparability Question
- Day 2: Critical Quality Attributes, Risk Ranking and ICH Framework
- Day 3: Comparability Protocol Design and Analytical Characterisation Toolbox
- Day 4: Tiered Statistics, Stability Comparability and Bridging Decisions
- Day 5: Case Work: Analytical Similarity Exercise and Comparability Protocol
- Skills You Will Gain
- Why Attend This Course
- Conclusion
Where else does this programme run?
Also scheduled in 7 other cities.
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