📆 4- 5 October, 2021
💻 Online course
ASPHALION experts Lidia Cánovas and André Mota, together with other three excellent lecturers will share their in-depth knowledge with you and will address the following processes: variation, regulation, classification guideline, eSubmission, and variation management in this course organized by FORUM INSTITUT.
The online training course will cover the following topics:
· Classification and submission
· Type IA notification, Type IB and II variations
· Grouping and worksharing
· Variation management
· Quality-related variations: Changes in the production process, analytics, formulation and packaging
AIMS AND OBJECTIVES:
This seminar will bring you the latest in the planning, classification and submission of variations.
Day 1 addresses regulatory requirements in detail, particularly guidance documents, variation classification, use of the variation (e-)application form and organisation of grouping and work sharing.
Day 2 addresses the classification and handling of quality-related changes. Case studies on how to work with the classification guideline and the Q&A paper will reinforce your knowledge.