eCTD Submissions

PTI/CPD UK

18 CPEs

More and more data is gathered and presented to support the quality, safety and efficacy of a drug. The quality and the consistency in the quality needs to be assured during the entire product lifecycle to safeguard patients. Similarly, the benefit-risk ratio of the drug’s usages need to be monitored and evaluated during the product’s lifecycle. Hence, its supporting dossiers are subject to continuous change. The eCTD allows to reflect the product’s lifecycle, with the documents that support the quality, safety and efficacy of a drug. But how does that eCTD lifecycle work? What is the impact on the document granularity and naming of documents? What do we mean by eCTD-ready documents? How do we create an eCTD? And what does a validation of an eCTD tell us? How can eCTDs for the same product be managed across multiple countries? These are all questions that will be addressed during this three-day workshop.

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Course Content

Who Should Attend

This is a must-attend workshop for: Regulatory Affairs professionals involved in submission procedures, Professionals in documentation registration, dossier development, and electronic submissions The workshop will also benefit: Publishing and Medical Writing professionals, Senior Regulatory Affairs Scientists, Development & Quality Manager, Licence Compliance Officers, QA Pharmacists, Senior Principle Statistical Programmers, Systems Managers, Certification Officers and Consultants

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