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Course Variations n Europe
Your regulatory and
procedural guidance
2018-12-08 2019-04-09 Amsterdam Marriott Hotel Stadhouderskade 12 1054 Amsterdam amsterdam@marriott.com +31 20 6075555 +31 20 60075511

Variations in Europe

Your regulatory and procedural guidance

Variation regulation, classification guideline, eSubmission, variation management - all processes explained in this course.
Topics
    Day 1: Classification and submission
  • Fundamentals and classification
  • Type IA notification
  • Type IB and II variations
  • Grouping and worksharing
  • Variation submission
  • Day 2: Quality-related variations
  • Changes in the production process
  • Changes in the formulation and analytics
  • Package and production variations

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, Utrecht

Marta Gorecka
DADA Consultancy B.V., Nijmegen, The Netherlands

Michiel Hendriks
DADA Consultancy, Nijmegen, The Netherlands

Speakers Day 2
Rabiea Abdullah
Senior Regulatory Affairs Specialist, United Kingdom Former Quality Assessor in an EU Regulatory Agency

Dr. Veronika Alt
ERA Consulting GmbH, Germany

Cristina Elena Stanca
MSD Ltd., Hoddesdon, Hertfordshire, United Kingdom


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