During more than 30 years of professional experience in the pharmaceutical industry, Helmut held senior positions in QC, Project Management, Regulatory Affairs, Pharmaceutical Development and Quality Assurance. He worked for 3 years in India to set up a pharmaceutical development center for ratiopharm GmbH as a greenfield project. Since 2016 he is supporting the pharmaceutical industry as an independent consultant in the areas of Drug Regulatory Affairs and Quality Assurance. Due to his in-depth experience in R&D as well as the GMP area, he perfectly knows the challenges and opportunities at the interface between these fields. Additionally, he acted as a visiting lecturer at different universities teaching Drug Regulatory Affairs, including Biosimilars and Quality Assurance.
Events/Masterclasses Dr. Helmut Vigenschow is currently speaking at
Pharma
New ICH & EMA Quality Guidelines Videorecording
At your convenience
Training Course | Online - Video Recording
In summary, this course will help the delegates to identify important new GMP and Regulatory aspects which should be considered throughout the entire life cycle of their specific products and avoid waste of time and money, thereby.
Quality & Regulatory Requirements for Biosimilars in the EU
Online Live Stream
The training aims to create deeper understanding why biotechnological products - and as a consequence Biosimilars - are a unique product category and what aspects have to be considered in R&D and Drug Regulatory Affairs.
In summary, this course will help the delegates to identify important new GMP and Regulatory aspects which should be considered throughout the entire life cycle of their specific products and avoid waste of time and money, thereby.
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During more than 30 years of professional experience in the pharmaceutical industry, Helmut held senior positions in QC, Project Management, Regulatory Affairs, Pharmaceutical Development and Quality Assurance. He worked for 3 years in India to set up a pharmaceutical development center for ratiopharm GmbH as a greenfield project. Since 2016 he is supporting the pharmaceutical industry as an independent consultant in the areas of Drug Regulatory Affairs and Quality Assurance. Due to his in-depth experience in R&D as well as the GMP area, he perfectly knows the challenges and opportunities at the interface between these fields. Additionally, he acted as a visiting lecturer at different universities teaching Drug Regulatory Affairs, including Biosimilars and Quality Assurance.
