Sponsored Webcast: Beyond Translation: The Centralised Procedure

1.0
RAC Credits
Wednesday, 10 April 2019 (12:00 PM) - Wednesday, 10 April 2019 (1:00 PM) (Eastern Time (US & Canada))

Sponsored by: 




12:00 – 1:00pm EDT

* This webcast focuses on the pharmaceutical sector.

In 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 pharmaceutical company.

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.

With 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.

Join 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 deadline management.

Learning Level:

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. 

Learning Objectives

After attending this webcast, you will be able to: 

  • 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.

 

Who Should Attend?

  • Regulatory affairs professionals in Europe
  • Member-state reviewers
  • Regulatory affairs labeling experts

 

Registration Information
Webcast registration includes access to handouts, presentation slides and the on-demand recording for one year.

 

Speakers

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 workflows. 

Register