Maintaining regulatory compliance for marketed drug products is a major task in all pharmaceutical companies. This task can create around 70% of the workload of regulatory affairs departments. It is business-critical to optimize the entire lifecycle management from R&D over product launch to the marketing phase and even to product discontinuation. Conflicts, mostly resulting from different approaches and priorities, can have negative impact on business processes even outside the R&D or GMP areas.
This masterclass describes current requirements how a baseline CMC dossier should be developed based on a solid and robust knowledge fundament on the drug product. Knowing the factors impacting product quality will enable the entire company to set up a transparent and well-structured lifecycle management, ensuring regulatory compliance and saving time and money.
Understand the different purpose and scope of GMP documents and regulatory documentation.
What are the different levels of detail in CMC versus GMP documentation?
Gain insight into the development and CMC strategies to pro-actively avoid changes
Understand the concept of Quality by Design development for APIs and finished products.
How should manufacturing processes be described in the CMC dossier compared to the GMP documents? What level of detail is required and recommendable?
How will new and upcoming guidelines impact our business?
Understand how quality risk management according to ICH Q9 should support product lifecycle from baseline CMC to variations.
What are key activities to ensure regulatory compliance?
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 Affair, Quality Assurance and as QP. 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 acts as a visiting lecturer at different universities teaching Drug Regulatory Affairs.