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| Category |
Health: Pharmacy
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| Category 2 |
Health: Medicine
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| Category 3 |
Business: Consulting
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| Contact |
Jan de Rooystraat 8
5141 EN, WAALWIJK
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| Description |
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.
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| Additional Information |
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
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