AMPLEXOR’s 2019 Webinar Program Opens with February Focus on Regulatory Information Management and Labeling Compliance

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AMPLEXOR’s 2019 Webinar Program Opens with February Focus on Regulatory Information Management and Labeling Compliance


BROOMFIELD, Colo.–(BUSINESS WIRE)–The first two webinars inAMPLEXOR
Life Sciences’
2019 webinar program have been announced, focusing on
“Regulatory Information Management (RIM): Delivering Better Efficiencies
Across Operations” and “Ensuring Compliance for Pharma Companies Through
Local Label Deviations.”

The first webinar –Regulatory
Information Management (RIM): Delivering Better Efficiencies Across
Operations
– takes place on 26 February. Frits Stulp, Managing
Director, Iperion Life Sciences Consultancy, will explore how
automation, which used to mainly be about standardizing your way of
working in such ways that manual processes could be replaced by
machines, has now matured to the point where informed decision-making
based on high-quality data lies within reach.

He will also show how the introduction of product information data
standards, such as IDMP, a new generation of RIM systems and better
integration of information flows, enables organizations to provide the
right information to the right people at the right time so they can make
the right decisions. In this webinar, Frits will provide you with
valuable insights on where he believes the industry is going and offer
recommendation on how you should get started – all based on best
practices and real-life experiences.

The second webinar –Ensuring
Compliance for Pharma Companies Through Local Label Deviations

takes place on 28 February. Kathleen O’Brien, Director, Business
Development, AMPLEXOR Life Sciences, will present a guide to avoiding
regulatory trouble with the Health Authorities. She will argue that many
global pharmaceutical companies are now faced with a volume of content
in the field that has grown to a point where the quality of that
labeling is unknown. Assessment of what exists and correcting the
process to avoid pitfalls in the future can therefore be a daunting task.

In this session, Kathleen will review a retrospective labeling case
study that not only provided data to identify deviations in local
labeling, but also shed some light on the path forward. In addition,
AMPLEXOR’s David Gwyn, Global Solution Architect, will share an overview
of options to ensure compliance by leveraging the AMPLEXOR Life Sciences
Suite.

TheRegulatory Information Management (RIM): Delivering Better
Efficiencies Across Operations
webinar will take place on 26
February 2019: Session A: 10 a.m. EST and Session B: 1 p.m. EST. To
register for this webinar,click
here
.

TheEnsuring Compliance for Pharma Companies Through Local Label
Deviations
webinar takes place on 28 February 2019 at 1 p.m. EST. To
register for this webinar,click
here
.

About the Presenter

Frits Stulp, Managing Director, Iperion Life Sciences Consultancy
Frits
Stulp is the managing director of Iperion Life Sciences Consultancy and
IDMP SME. He has more than 18 years of experience in the Life Sciences
industry. As a project manager, he specialized in the management of IT
projects for regulatory compliance and has been the program manager of
the first completed IDMP implementation program. Frits serves several
clients as IDMP program advisor. He has been a member of the EMA ISO
IDMP Task Force and is an active promoter of IDMP at conferences and
webinars.

Kathleen O’Brien, Director, Business Development – AMPLEXOR Life
Sciences

Kathleen O’Brien is director of business development
with AMPLEXOR Life Sciences and a 15-year veteran of the translation
industry. Kathleen has a background in linguistics and has held various
roles in the translation business: vendor, project and account
management, as well as new business development, giving her a unique
perspective into both translation operations and how translation impacts
the globalization needs of her clients in the pharmaceutical and medical
device industries. She proactively collaborates with her life sciences
client partners on a daily basis to help them set their localization
strategies.

David Gwyn, Global Solutions Architect – AMPLEXOR Life Sciences
With
more than 25 years of experience in the Life Sciences industry, David
Gwyn is a seasoned executive with extensive experience delivering
solutions to customers, with a particular focus in the areas of
regulatory information management (RIM), content management and
collaboration. As a global solution architect for AMPLEXOR Life
Sciences, his main focus is aligning customer needs with the
capabilities of the company’s Life Sciences Suite and ensure that the
solution meets the needs of the customer. He also leads the DIA EDM
Submission Reference Model team that developed a document architecture
for use when designing and building content management solutions.

About AMPLEXOR Life Sciences

AMPLEXOR Life Sciences assists organizations developing pharmaceuticals,
medical devices, and biotechnology with launching products and breaking
into new markets quickly. Our proven solutions as well as professional
and business services expedite the creation and delivery of consistent,
compliant, high-quality and global content – both physical and digital.

AMPLEXOR Life Sciences boasts a rich 25+ year history of serving
pharmaceutical producers, medical device manufacturers, and
biotechnology companies.

For more information, go to www.amplexor.com/lifesciences.

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