Overview:
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. Join us for an insightful webinar on the critical role of specialized regulatory translation services in global submissions.
Key discussion topics:
- 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
Who should attend:
This webinar will benefit:
- Regulatory affairs professionals: Those responsible for managing global submissions and ensuring compliance with diverse regulatory requirements.
- Translation and localization managers: Those tasked with managing language services and ensuring high quality, compliant translations
Presenters:
Sarah Jackson
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.
Lena Mazurek
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 7 years, she has focused on Regulatory Affairs translation processes, driving strategic growth and development plans.
Shermayne Nicolaou
Shermayne Nicolaou, 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.