Finding the roadmap to IDMP success with Amplexor

20 April 2021

This week, Amplexor experts Agnes Cwienczek and David Gwyn will present at the virtual Global Pharmaceutical Regulatory Affairs Summit, which aims to show how to achieve IDMP compliance, enrich the overall global compliance strategy and incorporate business benefits. Together, they will explore how the recently published IDMP Implementation Guide v2 will impact on the life sciences industry. This long-anticipated event starts the clock for the implementation of the product and substance data submission iteration 1 timelines in the EU. But what does it mean to companies and what must be considered? How can we be certain we are IDMP-ready?

The webinar will conclude with a demonstration of practical examples of how the Amplexor Life Sciences Suite is supporting companies on their IDMP implementation journey.  

This presentation, available as a webinar, lays out the roadmap to IDMP success, and elaborates on key aspects, in particular:

  • the major changes IDMP is introducing to the industry
  • how IDMP speeds the shift from a document to a data-centric world
  • the opportunities and challenges of bringing IDMP to fruition
  • how IDMP influences the ecosystem of people, data, process and technology
  • the critical success factors of IDMP implementation

About the speakers

Agnes Cwienczek

Head of Product Management and Consulting, 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.

David Gwyn

Vice President, Amplexor Life Sciences
With more than 25 years of experience in the Life Sciences industry, David Gwyn is a seasoned executive with extensive experience. As a Vice President for Amplexor Life Sciences, David’s main focus is aligning customer needs with the capabilities of the company’s Life Sciences Suite to ensure that the solution meets the needs of the customer.

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