Unlocking global strategies with proactive regulatory translation management

Life Sciences, Pharmaceutical Regulation, Pharma,
  • Friday, November 15, 2024 | 10am EST (NA) / 3pm GMT (UK) / 4pm CET (EU-Central)
  • 60 min

In the realm of regulatory submissions, translation services are crucial in ensuring consistency and accuracy for global submission strategies. Relying on multiple providers can introduce challenges such as inefficiencies and inconsistencies, which may complicate and delay the submission process. Without proper planning, organisations risk encountering unforeseen obstacles that can disrupt timelines.

Integrated language services play a crucial role in ensuring consistency and accuracy. By adopting best practices, such as leveraging integrated regulatory and language services, companies can streamline processes, reduce cost and improve overall submission quality.

In this webinar, the speakers will delve into the best practices for incorporating translations into global submission strategies, emphasizing on the critical importance of accuracy in translations for regulatory compliance. The discussion will explore common challenges and inefficiencies encountered in the translation process and provide practical solutions to overcome these obstacles.

Moreover, the session will highlight the advantages of integrating regulatory expertise with language services, demonstrating how this synergy can streamline processes, reduce errors and expedite time-to-market for global submissions.

Register for this insightful webinar to gain insights into the critical role of specialized regulatory translation services in global submissions.

Speakers

Sarah Jackson, ICON Patient Centred Sciences

Sarah Jackson, Director, Business Development, ICON Patient Centred Sciences

Sarah Jackson has over 22 years of experience in regulatory and clinical support for the life science sectors. She has dedicated 17 years of her career ensuring compliance and excellence in the world’s largest pharmaceutical Regulatory Operations division, including a pivotal role as head of Regulatory Translations leading complex translation needs and ensuring regulatory adherence before transitioning to Business Unit Lead at ICON.

Message Presenter
Lena Mazurek, ICON Language Services

Lena Mazurek, Director of Project Management, ICON Language Services

Lena Mazurek is the Director of Project Management at ICON Language Services, based in Madrid, Spain. With over ten years of experience in specialized language services and technology, Lena brings a wealth of expertise, particularly in serving pharmaceutical clients. For the past seven years, she has focused on Regulatory Affairs translation processes, driving strategic growth and development plans.

Message Presenter
Shermayne Nicolaou, ICON Regulatory Project Services

Shermayne Nicolaou, Global Head, ICON Regulatory Project Services

Shermayne Nicolau, Global Head, Regulatory Project Services, has 12 years of pharma clinical and regulatory experience in addition to eight years of CRO regulatory experience. She has extensive experience leading large-scale regulatory projects such as divestments/acquisitions, global market expansion, harmonization and integration as well as regulatory work transfers from client/vendor to vendor.

Message Presenter

Who Should Attend?

This webinar will benefit those responsible for managing global submissions and ensuring compliance with diverse regulatory requirements or professionals in the following fields:

  • Regulatory affairs
  • Translation and Localization Managers
  • Regulatory communications
  • Medical communications
  • Translators/Medical Writers

What You Will Learn

Attendees will learn about:

  • Best practices for integrating translations into global submission strategies
  • The importance of accurate translations
  • Common challenges and inefficiencies and how to overcome them
  • Advantages of integrated regulatory and language services

Xtalks Partner

ICON

ICON is the world’s leading clinical research organisation, powered by healthcare intelligence. From molecule to medicine, we advance clinical research providing a comprehensive suite of outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. We develop new innovations, drive emerging therapies forward and improve patient lives. Our outsourcing models can be adapted to suit small local trials to large global programs, including full service, standalone services, FSP and full asset development.

With headquarters in Dublin, Ireland, ICON employs approximately 41,150 employees in 113 locations in 53 countries.

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