COURSE
Life Sciences and Pharmaceuticals: Regulatory Affairs and Science
INR 59
Description
In-depth coverage of global regulatory affairs, submission workflows, data standards, and participation in scientific/industry working groups.
Learning Objectives
Learners will deliver submission-ready data packages, support cross-border registration, and participate in regulatory science projects.
Topics (7)
1
Digital Tools for Regulatory Intelligence
Regulatory policy text mining, dashboards.
2
Global Regulatory Registration and Lifecycle
Dossier content management, multi-market registration, change tracking.
3
Structured Product Labeling and Serialization Data
Label content, artwork, UDI barcoding, EU FMD.
4
Participation in Regulatory Science Consortia
Regulatory pilots, consortia, multi-stakeholder working groups.
5
Regulatory Project and Change Management
Regulatory project tracking, workflows, Gantt, critical path.
6
Electronic Submission Standards: eCTD, IDMP, SPL
Global eCTD, data standards, automation, submission validation.
7
Harmonization of International Regulatory Requirements
Harmonization mapping, multi-country workflow.