Module 1 2021

25/06/2021

Electronic Submissions – Strategic Implications

Matt Pazdernik, Executive Director Regulatory Operations – EMEA, Organon

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals i Regulatory Affairs

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Learning Outcomes

• At the end of this session the attendee should be able to: • Describe the key benefits and challenges for adopting electronic submissions in the pharma industry • Describe the key components and differences between the two most common electronic submission formats: the eCTD and NeeS formats • Understand the key challenges in developing a global electronic submissions strategy • Describe the acceptability of the eCTD and electronic submissions in the key global markets

The Organisation for Professionals in Regulatory Affairs

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