RIM – Is data driven Regulatory Information Management your reality? Registration

Date:11/4/2020

Time:1:00 PM EST

Duration:60 minutes

Many life science companies have undertaken a long journey to establish, expand and improve their Regulatory Information Management system landscape throughout the past years. Although much progress has been made and a well-established baseline is observed across the entire industry, there is still a journey ahead of us when it comes to the management of regulatory content. How far have companies managed to transition from a content to a data-centric approach and how well are they prepared to do so in future? What can we learn from those
who have achieved this next level of maturity and which system capabilities should we consider key to support such a transformation?

Agnes Cwienczek, AMPLEXOR's Head of Product Management and Consulting and David Gwyn, Vice President for AMPLEXOR Life Sciences, will elaborate further on the shift from a content/document-focused towards a data-centric approach and the triggers facilitating the move. They will discuss key capabilities of a data-driven solution and highlight the benefits to put data first. At the end of the presentation, They will conclude with a demonstration of practical examples how the AMPLEXOR Life Sciences Suite is addressing the arising data-
centric requirements of the industry.

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Speakers

Agnes Cwienczek

Head of Product Management and Consulting - Life Sciences

AMPLEXOR Life Sciences

Agnes has been in the position of Senior Life Sciences Consultant for Amplexor since May 2017. In her role as Life Sciences Consultant, Agnes is part of the Product Management team. Her main responsibilities are the contribution to the development and enhancement of the Amplexor Life Sciences Suite, supervision of the Life Sciences Consultants as well as the provision of business process and data management expertise to Amplexor clients in Regulatory Information Management, Document Management, and Submission Management. Before joining Amplexor, Agnes worked at Merck KGaA in Global Regulatory and Quality Assurance, where she was acting System and Process Owner for all regulatory owned systems, providing global leadership for the management of submission documents, regulatory data and archiving within the Merck Biopharma organization.

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.