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Introduction
Responsibilities of the MAH are summarized in the EMA “Reflection Paper” on Good Manufacturing Practice and Marketing Authorization Holders (EMA/419517/2021),
which has been implemented in Part III of the EU GMP Guide. These Regulatory/GMP obligations for the MAH start with the submission of the marketing authorization application. At that time, the applicant must already ensure that details provided in the dossier are reflected in the data established and activities performed so far. These requirements are continuous, for the entire life cycle of the medicinal product. Regulatory compliance is one key element of these obligations, it means the mutual conformity of the respective (local) marketing authorization (including ASMFs and CEPs) with the manufacture and release of active pharmaceutical ingredients and medicinal products over the whole life cycle. It covers the areas of development, manufacture, control strategy and stability, and respective monitoring and verification activities.
Who Should Attend
- The training is aimed at all persons with management responsibilities at marketing authorization holders together with all employees in various responsibilities in the areas of quality assurance, marketing authorization and pharmacovigilance. Personnel with responsibilities for pharmaceutical quality systems, change control, batch release, testing, and stability testing. Members of RA-CMC teams are responsible for the information provided in the dossier and respective variations. Quality assurance personnel with a focus on monitoring and verification activities.
Key Takeaways
Attendees of the masterclass will be able to answer questions related to MAH obligations
Meet The Trainer
Prof. Dr. Markus Veit is the managing director of ALPHA-TOPICS GmbH.
He studied pharmacy in Frankfurt, obtained his Ph.D. at the Julius-Maximilians University in Würzburg, and habilitated there.
He is a pharmacist with special training and experience in pharmaceutical analysis and validation. He is a member of the German pharmacopeial expert committee at BfArM. In the past 25 years, he has worked as a managing director in companies providing services for the pharmaceutical industry with a focus on pharma[1]ceutical development, testing, and regulatory affairs. At the same time, he designed and led numerous training and continuing education events for employees in the pharmaceutical and medical device industry.
