Some of the Learning Outcomes
The market share of drug products manufactured by means of modern biotechnology is constantly increasing. In Germany, it is close to 25% in value. This means that there will be a major cost-saving potential for the healthcare systems by the introduction of Biosimilar competition. New therapeutic options are opened for the treatment of severe medical conditions and it is obvious that this product category will become even more important in the future. Consequently, it is vital for generic pharmaceutical companies to consider extending their business scope from drug products with classical chemically synthetized API to Biosimilars. The training aims to create a deeper understanding of 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.
Get to know the Trainer
After his Ph.D. in protein chemistry, Helmut held senior positions in QC, Project Management, Regulatory Affairs, Pharmaceutical Development and Quality Assurance in the pharmaceutical industry. 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, Quality Assurance and strategic considerations. Due to his more than 30 years of professional 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.
Feel free to suggest the topics that you would like to learn about at
our Biosimilars in the EU In-House Training.
Request an Offer
Who should attend?
• Heads of R&D
• Heads of Business Development
• Heads of QC
• Heads of QA
• Pharmaceutical Development managers
• Manufacturing managers
• Stability control managers
• QC managers
• Drug Regulatory Affairs managers
• Pharmacovigilance managers
