Pharmaceutical Regulatory Affairs: CTD Dossiers, Registration Pathways and Variations – London, 1–5 Mar 2027
Pharmaceutical Regulatory Affairs: CTD Dossiers, Registration Pathways and Variations runs in London from Monday 1 March to Friday 5 March 2027 (1 Week). The fee is 23,000 SAR per participant. The same programme is also scheduled in 7 other cities.
- Dates
- Length
- 1 Week
- Fee per participant
- 23,000 SAR
- Format
- In person, London
- Venue
- Central London four-star
- Status
- Open for registration
- Week
- 9 of 2027
- Reference
- 887_21001
This session
1–5 Mar 2027
This Pharmaceutical Regulatory Affairs: CTD Dossiers, Registration Pathways and Variations session in London runs from Monday 1 March to Friday 5 March 2027 (week 9, Q1 2027). It is the 1st of 2 dates in London in 2027, at a fee of 23,000 SAR, the same for each of them. Registration is open for this date. It is held in person at Central London four-star.
When else does it run in London?
- 1 – 5 March 2027 This date 23,000 SAR
- 21 – 25 June 2027 23,000 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: 887_21001. 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 Pharmaceutical Regulatory Affairs: CTD Dossiers, Registration Pathways and Variations in London start and finish?
It starts on Monday 1 March and finishes on Friday 5 March 2027: 1 Week.
How much does Pharmaceutical Regulatory Affairs: CTD Dossiers, Registration Pathways and Variations in London cost?
The fee for this date is 23,000 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 London, at Central London four-star.
What does this programme cover?
Pharmaceutical regulatory affairs slows product launches when dossiers are filed with gaps in Module 3, when the wrong registration pathway is chosen, when deficiency letters are answered late or partially and when site changes are implemented before the variation is classified. This Core Concept course trains regulatory, quality and medical staff to plan CTD and eCTD submissions, select full, abridged, biosimilar or reliance routes, control labelling and artwork, answer assessor questions and manage variations and renewals. Participants build a Registration Dossier Plan and Variation Strategy for a case product.
The programme outline covers:
- Introduction
- Course Objectives
- Target Audience
- Course Outline
- Day 1: Medicine Regulatory Lifecycle and the Registration Landscape
- Day 2: CTD Architecture, eCTD Publishing and Registration Routes
- Day 3: Generic Evidence, Product Information and Assessor Queries
- Day 4: Post-Approval Variations, Renewals and CMC Change Management
- Day 5: Case Product Registration Dossier Plan and Variation Strategy
- 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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