FORUM · Institut für Management GmbH
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69115 Heidelberg
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Fax: +49 6221 500-505
Course: Global Variation and Life Cycle Strategies
Global Variation and
Life Cycle Strategies
2019-04-30 2019-04-30 Steigenberger Airport Hotel Unterschweinstiege 16 60549 Frankfurt +49 69 6975-0 +49 69 6975-2505

Global Variation and Life Cycle Strategies

Strategic planning, roll-out and management of variations and renewals worldwide

In this seminar you will get strategic know-how for the roll-out of variations and regional know-how for the submission in LATAM, GCC and Asia.
  • Variations regulated in LATAM, Asia and the GCC
  • EU variations system vs US variations system
  • Roll-out of major variations
  • Life cycle management with affiliates and with local partners
  • Worldwide (e)Submission

Aims and objectives

This seminar provides you with a thorough understanding of the challenges of global life cycle management. Three experts explain how to plan and roll out variations globally and how to collaborate with local partners on further life cycle duties.
After having attended the seminar, you will be capable of efficient global life cycle management.
The speakers will provide practical examples on CCDS and CMC variations. However, if you are interested in the content aspect of CMC variations, we would recommend the "Global CMC Requirements "seminar.
Who should attend
This seminar addresses the needs of regulatory and medical affairs staff involved in global life cycle management.
Basic knowledge of the EU variations system is a prerequisite for the seminar and can be obtained in further seminars or e-learning programmes by FORUM Institut.
Your speakers
Ellen Frey-Stanislawski, MDRA
Merck KGaA, Darmstadt, GERMANY

Dr. Jens Krämer
Boehringer Ingelheim International GmbH, Ingelheim, GERMANY

Dr. Vicente Tur

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