This course will offer insight into the regulatory environment of human pharmaceutical products, thereby focusing on the EU procedures and submissions and focusing on eCTD for global use. Emphasis will be on understanding the multidisciplinary tasks for the preparation and maintenance of regulatory documents.

KEY TOPICS EU regulatory environment for human pharmaceutical products and its place within worldwide regulatory affairs. Product lifecycle Regulatory procedures in the EU Types of application in the EU Types of submissions in the EU and beyond Formats of regulatory dossiers (eCTD, NEES, paper) eCTD lifecycle management Workshops on preparing and maintaining regulatory dossiers LEARNING OBJECTIVES At the conclusion of this course the attendants should be able to: Understand the regulatory environment for pharmaceutical products Know where to locate regulatory information in a regulatory dossier See how the eCTD lifecycle reflects the product lifecycle Understand the importance of reusability of documents to support multiple countries and products See where regulatory information is reused within a pharmaceutical company Contribute to the first-time-right eCTD-readiness of documents Contribute to implementation processes for eCTD-readiness of a company Participate in integration of document management and registration tracking across a pharmaceutical company WHO SHOULD ATTEND? Regulatory Affairs Professionals from HQ and local affiliates Regulatory Operations Professionals CMC Technical Writers Nonclinical and Clinical Medical Writers Pharmacovigilance Managers QA and Compliance Professionals ICT Managers involved in document and submission management Contractors