Enabling efficient Submission Content Management & Publishing

About the webinar

Submission Management & Publishing is a critical activity in Regulatory Operations with an ever-increasing need for cost and time efficiency while accommodating the flexibility to quickly react to changes or urgent submission needs. It became an essential part of the overall Regulatory Information Management process throughout the past years, instead of being an isolated domain in the operations space.

Many companies succeeded in establishing well-defined Submission Content Management & Publishing processes stretching from the global to the local organisation, including many processes and content contributors and consumers like the service providers supporting the company’s delivery needs. Recently, additional attention is being paid towards automation of routine tasks within and beyond Submission Content Management & Publishing activities to further improve efficiency and reduce human errors.

In this webinar, we’ll discuss key success factors and improvement possibilities in the area of Submission Content Management & Publishing in the context of E2E process, system, and data optimizations including:

• Global/Local Submission Management & Publishing;
• Submission Process Connectivity;
• Submission Data Connectivity;
• Submission Content Planning;
• Submission Automations;
• Submission Analytics;
• Submission Simplification & Usability.

About the speaker

Agnes Cwienczek is Head of Product Management and Consulting at Amplexor Life Sciences. Agnes’ main responsibilities are the provision of business and compliance requirements for the Amplexor Life Sciences Suite, the supervision of the Life Sciences Consultants and the delivery of process and data management expertise to Amplexor clients in Regulatory Information Management, including Document Management, Submission Management and Labeling Management.

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