* This webcast focuses
on the pharmaceutical sector.
this webcast, we will discuss the expectations of the language solutions
provider in its role within centralised procedure projects and explore how to
go ‘beyond’ translation in order to reduce the administrative burden on the
EMA Centralised Procedure allows global pharmaceutical companies to obtain
marketing authorization of their products for use across all EU and European
Economic Area (EEA) countries through a single application. Throughout this
process, the applicant must adhere to strict regulatory requirements associated
with translating pharmaceutical product information.
multiple stakeholders, potentially large translation volumes, detailed review
phases, tight deadlines, and other administrative requirements, the centralised
procedure is highly complex and necessitates a unique style of collaboration
between the pharmaceutical company and language solutions provider. This
partnership relies on the language solutions provider to be less transactional,
and more consultative.
us as we discuss “At Risk” translations, QRD compliance, Member- state review,
administration of bookmarked PDFs and Appendix V files, as well as workflow and
Intermediate: Content is designed based upon the assumption that individuals
have basic knowledge of the topic(s) and/or demonstrated
competence related to the topic(s). Higher-level concepts are
introduced during lectures; exercises requiring synthesis and/or application of
concepts are incorporated into the activity.
After attending this webcast, you will be able
- Leverage a Language
Service Provider to reduce internal resources needed in the life cycle of
the centralised procedure.
- Effectively use a
Procedure Management Portal to drive efficiency.
- Leverage a translation
automation tool to enforce quality and consistency in translations.
affairs professionals in Europe
affairs labeling experts
includes access to handouts, presentation slides and the on-demand recording
for one year.
Ben Rainforth, head of European sales,
RWS Life Sciences
Ben Rainforth is the head of European sales at
RWS Life Sciences and has consulted with enterprise-level companies with a
growing demand for localization services for over 12 years. His past seven
years has been focused on collaborating with the world’s leading pharmaceutical
companies and their CROs in the area of centralised procedure. Rainforth has a
proven track record of providing clients with excellence service and ensuring a
positive customer experience. He is
known for his expertise in on-boarding new regulatory divisions in conjunction
with operational teams.
Chandra Rivers, program director,
RWS Life Sciences
Chandra Rivers has been in the Life Sciences translation industry since
2006 in various capacities. As program director for RWS Life Sciences, she
develops custom localization solutions for pharmaceutical clients, in
particular for regulatory teams managing centralised procedure submissions. Rivers
serves as a consultant on managing the localization of centralised procedure
submissions among other highly regulated content. Her specialty is to garner efficiencies by
optimizing her clients’ procedures by developing and deploying seamless