Product: EAEU Submission Standards Implementation Journey

EAEU submission standards are on one hand well-structured and technically more advanced than ICH eCTD but on the other hand also containing several definition gaps and technical implementation challenges. As both authorities and industry learn by experience, vendors struggle to make both of them happy with their submission tools. Discover the specifics and challenges of EAEU electronic submission format implementation.Learn how Amplexor tackled EAEU submission challenges and implemented them in the Life Sciences Suite with a phased approach.

About the speaker
Renato Rjavec

Renato Rjavec

Director, Product Management - Life Sciences @ Amplexor

As Director of Products, Renato is responsible for Amplexor’s Life Sciences Product Management. He has more than 14 years of experience in analyzing, designing and implementing end-to-end regulatory solutions for the Life Sciences industry. In his first nine years at Amplexor, Renato managed several implementations of integral regulatory and quality management solutions for global pharmaceutical companies as well as health authorities. Over the past four years, Renato established the Product Management organization that focuses on innovation, compliance, and quality of its product portfolio. Renato has a bachelor’s degree in Computer and Information Science from Ljubljana University.

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