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Course Variations n Europe
Variations: Your regulatory and
procedural guidance
2019-12-02 2020-04-03 Holiday Inn Leiden Haagse Schouwweg 10 2332 KG Amsterdam / Leiden +31(0) 71 535 5555 +31(0) 71 53 55 553

Variations in Europe

Your regulatory and procedural guidance

Variation regulation, classification guideline, eSubmission, variation management - all processes explained in this course.
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.
Who should attend
This practical seminar is aimed at anyone involved in planning, creating or submitting variations.

Employees in the following departments will particularly benefit from the seminar:

  • regulatory affairs;
  • production; and
  • quality assurance
Your speakers
Speakers Day 1
Kora Doorduyn-van der Stoep
Medicines Evaluation Board MEB), Utrecht, The Netherlands

Lidia Cánovas
ASPHALION S.L., Barcelona, Spain

Speakers Day 2
Dr. Veronika Alt
ERA Consulting GmbH, Germany

Cristina Elena Stanca
Pharmedd Services Ltd., London, Great Britain


Speaker both days
André Mota
ASPHALION S.L., Madrid Office, Spain


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