AMPLEXOR Life Sciences Presents at Informa eRegulatory Summit 2019 and Global Regulatory Affairs Summit

April 8, 2019 Off By BusinessWire



Life Sciences companies must manage an increasingly complex
regulatory environment, ensuring products get to market on time and
without issues, while maintaining compliance at all times.

This growing complexity and integration of the world of regulatory
affairs has led to Informa combining its eRegulatory
Summit 2019 and Global Regulatory Affairs Summit
into one
event to share insights, best practices and policy further and
faster. Delegates will be positioned to learn about such key
topics as implementing global e-submissions strategies and
improving data quality by implementing SPOR, while also taking
guidance from some of the world’s leading experts in data and
submissions, who will provide actionable insights to help
attendees improve their regulatory strategy.

Romuald Braun, Vice President, Strategy, AMPLEXOR Life Sciences,
will be presenting, “Turn Compliance into Value – Decrease
Complexity, Increase Compliance and Reduce Total Costs of
Ownership.” In highly regulated organizations, the complexity of
data systems is a significant driver of cost and compliance risk.
Complex, siloed systems can be difficult to maintain from an IT
perspective, and cause data consistency issues, which can lead to
non-compliance and possible product removal from shelves until any
compliance issues are resolved. In order to reduce these effects, a
more holistic design model for data collection and maintenance, and
processes is desirable. When this type of system is implemented,
content and data is efficiently organized, trackable and shared
throughout an organization.
Braun will discuss the use of structured authoring and how it can
reduce costs and increase compliance. He will also focus on how this
system creates consistency between data and content, process
automation, faster product-to-market, and R&D IT benefits.


This year’s combined event expects more than 330 regulatory
professionals from 160 companies to meet, discuss and network with
other regulatory professionals from across the regulatory spectrum
and from all around the world.
Delegates will have the opportunity to hear from leaders in the
fields of data and submissions to enhance their knowledge of the
industry as a whole, providing them a clear view of the bigger
picture and practical advice on information management and how it
relates to the evolving regulatory requirements.


8 – 10 April 2019
“Turn Compliance into Value – Decrease Complexity, Increase
Compliance and Reduce Total Costs of Ownership.” – presentation by
AMPLEXOR’s VP of Strategy, Romuald Braun – 8 April, 15:10


Crowne Plaza Fira Center
Barcelona, Spain

Addressing regulatory challenges are top of the agenda for many
organizations in life sciences, and AMPLEXOR Life Sciences can
help address these and more. Throughout the summit, AMPLEXOR’s Life
regulatory solution experts will available to
discuss your organization’s regulatory challenges, demonstrating how to
improve data quality to ensure compliance with regulatory standards.

To register for the event, please visit here.

To learn more about the AMPLEXOR Life Sciences suite of products and
services, please visit here:

About AMPLEXOR Life Sciences

AMPLEXOR Life Sciences assists
organizations developing pharmaceutical drugs, medical devices, and
biotechnology with launching products and breaking into new markets
quickly. Our solutions and services expedite the creation and delivery
of consistent, compliant, high-quality and global content – both
physical and digital. Our services include technology consultancy,
implementation, and management services as well as technical writing,
medical translation, and linguistic validation.

AMPLEXOR employs 1,850 people in 23 countries across four continents and
has a rich 25+ year history of serving pharmaceutical producers, medical
device manufacturers, and biotechnology companies.

For more information, go to


Sherri Hughes-Smith
Senior Marketing Director
[email protected]