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Seminar CMC Management in Regulatory Affairs
Quality data for
marketing authorisation
in Europe
2018-12-25 2019-09-26 NH Amsterdam Centre Stadhouderskade 7 1054 ES Amsterdam nhamsterdamcentre@nh-hotels.com +31 20 685 1351

CMC Management in Regulatory Affairs

Quality data for marketing authorisation in Europe

This course will give you an in-depth knowledge on the CMC requirements for the marketing authorisation.
Topics
  • Regulatory requirements in the EU and the ICH region
  • Essential quality data for marketing authorisation
  • CMC documentation: Module 3, ASMF, CEP and Quality Overall Summary
  • Management of post-approval changes
  • Classification of quality related variations

Aims and objectives

This training course will give you in-depth knowledge of CMC requirements for marketing authorisation. Our experts will address essential quality data and provide strategic information on CMC writing and maintenance.
Who should attend
This seminar addresses the needs of those working in the pharmaceutical industry. It will particularly benefit CMC managers, regulatory affairs
managers and managers of the quality assurance department dealing with the
  • compilation and the maintenance of Module 3 of the CTD,
  • classification of quality-related changes.
Your speakers
Jan-Jaap Scherpbier, MSc
Garden State Pharmatech, The Netherlands

Aimad Torqui
MSD Netherlands, Netherlands

Dr. Helmut Vigenschow
ViPharmaService

André Mota
ASPHALION S.L.


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Our international course portfolio

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Abbreviations, Glossary

List of abbreviations

Many abbreviations for processes, documents and authorities, amongst others, are used in all regulatory areas. We have compiled the most important ones for you. Our list of abbreviations can be freely downloaded here.

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IMI (Innovative Medicines Initiative) defined quality criteria for professional training and education. We follow these criteria and, as a signatory, we are an active partner in further developing and optimising the quality standards.

An aggregate evaluation of 2701 participants' feedback on 348 healthcare training courses (evaluation period from 10.2017 - 09.2018) produced a result of 1.6 (based on a school grading system of 1-6).

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