NEW

Life Sciences Localization Master Class

This course will enable participants to understand what localizing life sciences content entails and how it can be effectively managed in a life sciences regulatory context. This class will focus on how to incorporate process and technology to effectively achieve compliance with these requirements.

Life Sciences Localization Master Class
Life Sciences Localization Master Class

Master Class Details

Dates
May 1, 2024 - May 22, 2024

Format
4 classes, 2 hour each

Instructor:
Sonia Monahan

Fee
$750

Language
English

Register Now!

Cancellation Policy

Session #1: Wednesday, May 1, 5:00pm-7:00pm CEST / 11:00am-1:00pm EDT
Session #2: Wednesday, May 8, 5:00pm-7:00pm CEST / 11:00am-1:00pm EDT
Session #3: Wednesday, May 15, 5:00pm-7:00pm CEST / 11:00am-1:00pm EDT
Session #4: Wednesday, May 22, 5:00pm-7:00pm CEST / 11:00am-1:00pm EDT

This course will enable participants to understand what localizing life sciences content entails and how it can be effectively managed in a life sciences regulatory context. This class will focus on how to incorporate process and technology to effectively achieve compliance with these requirements.

Localizing content implies leveraging a mix of standards and best practices. Therefore this course will focus on selected challenges, pitfalls and experiences “from the trenches” that have proven to be critical to ensure that localization is and remains a profit driver. It will highlight how localization creates value that is recognized within globalizing organizations.

10% discount for 3 or more students from the same company  – please contact jill@localizationinstitute.com for more information.

Target audience

As this course is expected to cover a number of life sciences localization facets in a short time and in an interactive way, it is designed for leaders and practitioners with 2-5 years of localization experience or more than 5 years of international business experience. For those who are newer to life sciences localization, we recommend taking the ReadySetGo Life Sciences Localization Class prior to attending this master class.

  • Client or LSP Localization Project Managers, Localization Program Managers
  • Marketing directors and managers
  • Communication directors and managers
  • International project and program managers

Participants from any industry and any size of business will be welcome. Multinationals, scaleups and startups can send delegates to attend this course.

Course Curriculum 

Day 1 Take-aways

Setting up your Localization Program for Success in a regulatory context

  • Understanding the unique challenges of regulatory environment
  • Culture of quality and transparency
  • Designing a comprehensive KPI framework to drive continuous improvement
  • Leveraging measurable translation quality for success
  • Strategies for effective translation validation
  • Meeting FDA translation certificate requirements

Day 2-3 Take-aways

Hands-on recommendations for technology and workflow enablers to reduce time-to-market

  • Designing efficient, value-oriented translation workflows
  • Centralized content management systems integrated with LSP’s Translation management systems
  • CAT tools (selection, management)
  • Machine Translation
  • Generative AI/LLM’s
  • Terminology management
  • AutoQA
  • Readability
  • Redaction
  • Linguistic validation

Day 3 Take-aways

Best practices for vendor and translator qualification

  • Structuring effective RFP’s for life sciences
  • Ensuring subject-matter specialization
  • Information security / data privacy
  • Relevant quality standards
  • Effective vendor qualification audits

Day 4 break-out discussion sessions for Medical Device and for Pharma/Clinical Trials

Sample Medical Device topics:

  • Transparency for end patients and required proof of effectiveness during clinical trials
  • Collaboration between client and LSP’s on efficiently processing feedback from the field, SSCP’s
  • Ensuring consistency of content across de-centralized organizations

Pharma and clinical trials topics:

  • Move to centralized process in EU, requirement hard deadlines, all submissions done at once (not staggered)

Please note: recording or republishing any part of the class session is prohibited. We do this in order for students to be able to speak and share experiences freely with the instructor and their fellow classmates in a comfortable and safe environment without fear that something they say might later be made public.

About Your Instructor

Sonia Monahan

Sonia Monahan is a global content and localization strategist, with a specialization in process and technology optimization and regulatory compliance. With 30+ years of leadership experience in the localization industry, Sonia brings a wealth of knowledge and a proven track record of success in delivering exceptional content creation and localization solutions. Her core focus is supporting life sciences customers achievement of their corporate objectives for time to market, quality and cost, while ensuring compliance to all necessary regulations.

Sonia is the Principal of Peak Global Solutions, LLC. She has a BA in German and an MEd from Lesley College and is certified as a Lean Six Sigma Blackbelt and is a quality auditor for ISO 9001, 13485, 17100, and 18587. Her book, The Definitive Guide to Measured Translation Quality, co-authored with Jason Arnsparger, was published in 2014.