FORUM INSTITUT COURSE | Variations in Europe

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.

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.
September 10, 2021

📆 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.

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