How publishing is changing with eCTD 4.0

How publishing is changing with eCTD 4.0
The Regulatory Operations (RegOps) SPIN Steering Group is pleased to present “How publishing is changing with eCTD 4.0”.  This session has been designed to explore the key changes introduced by the Electronic Common Technical Document (eCTD) 4.0 and provides practical implementation examples, supported by real-world regulatory submission experience.



Date: 13/11/25
Duration: 14:00 – 15:00 GMT

Suitable for: 
TOPRA Members & TOPRA Special Interest Groups (SPINs) interested in:
          • Regulatory operations
          • Submissions publishing

Session Description:
This webinar will benefit participants through the coverage of:
          • What is eCTD 4.0, and what is changing with eCTD 4.0
          • How publishing is changing – Introduction of the continuous publishing concept
          • Practical Implementation – gain actionable insights from the eCTD 4.0 Pilot, grounded in real-world regulatory
                submission experience


Host


Danielle McVey Director, Regulatory Innovation Culture Strategy & Enablement, Pfizer and Reg Ops SPIN Chair, TOPRA
Building upon a strong foundation in Organisational Change Management, Danielle is passionate about driving cultural transformation and embedding innovation across regulatory functions. Danielle brings a people-first approach to strategy, helping shape the future of regulatory excellence.

Speaker(s)


Valeria Graffeo, Director of Regulatory Strategy, Veeva Systems 
Valeria is a regulatory expert with a MPharm and an MBA in International Business, and she has close to 20 years of experience in regulatory affairs. Valeria is a TOPRA Fellow and digital enthusiast, and she makes use of technology to support the advancement of the regulatory affairs profession.


Jacci Squire, Director of Publishing, Syneos Health 
Jacci is a publishing expert with nearly 20 years of experience in various roles across industry and consulting. In her current role, she is the Director of Publishing at Syneos Health.


Leigh Sandwell, Publishing Regional Director, EU/ROW, based in the UK, Pfizer
With deep expertise in regulatory submissions, technologies, and global requirements, Leigh has led the development and implementation of Pfizer’s eSubmission Strategy. Since joining Pfizer in 1998, he has held key roles across Regulatory Operations and Information Management.

Leigh is a long-standing member of the EFPIA eSubmission Focus Group and currently represents EFPIA on the EU Human Harmonisation Group. He has also contributed to multiple regulatory initiatives, including ICH M8 and M2, the eAF/CESSP Change Advisory Board, and the EU eCTD Maintenance Group.

 


PRICING
TOPRA Members: Free
Non-member: £60

 
When
13/11/2025 14:00 - 15:00
Where
ONLINE
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