Biologics Comparability and Biosimilars: ICH Q5E Protocols, CQAs and Tiered Statistics – Dammam, 23–27 May 2027
Biologics Comparability and Biosimilars: ICH Q5E Protocols, CQAs and Tiered Statistics runs in Dammam from Sunday 23 May to Thursday 27 May 2027 (1 Week). The fee is 19,500 SAR per participant. The same programme is also scheduled in 7 other cities.
- Dates
- Length
- 1 Week
- Fee per participant
- 19,500 SAR
- Format
- In person, Dammam
- Venue
- Eastern Province five-star
- Status
- Open for registration
- Week
- 20 of 2027
- Reference
- 622_18092
This session
23–27 May 2027
This Biologics Comparability and Biosimilars: ICH Q5E Protocols, CQAs and Tiered Statistics session in Dammam runs from Sunday 23 May to Thursday 27 May 2027 (week 20, Q2 2027). It is the only date in Dammam in 2027, at a fee of 19,500 SAR. Registration is open for this date. It is held in person at Eastern Province five-star.
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_18092. Quote it when you contact us.
Before you book, read our cancellation policy.
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Questions about this date
When does Biologics Comparability and Biosimilars: ICH Q5E Protocols, CQAs and Tiered Statistics in Dammam start and finish?
It starts on Sunday 23 May and finishes on Thursday 27 May 2027: 1 Week.
How much does Biologics Comparability and Biosimilars: ICH Q5E Protocols, CQAs and Tiered Statistics in Dammam cost?
The fee for this date is 19,500 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 Dammam, at Eastern Province five-star.
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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