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The interface between Development and GMP units is one of the most exciting in the pharmaceutical industry. Mutual understanding of the different regulatory environment and the functional priorities is a key success factor. Conflicts, mostly resulting from different approaches and priorities, can have negative impact on business processes even outside the R&D or GMP areas.

R&D needs flexibility and should not be over-regulated, whereas GMP concentrates on standardization and high throughput. On the other hand, R&D has to create a solid and robust fundament to enable manufacturing and quality control to work according to established and
efficient procedures.

The training aims to generate a common understanding of how to best interlink these two areas and create highly efficient processes from product development to routine manufacturing of generic pharmaceutical products.

Learning Outcomes

• Understand how Generics, Hybrid products, Biosimilars and WEU products are defined in the EU legislation
• How can development candidates for these product categories be defined based on already marketed target products as well as considering data exclusivity and IP protection of competitors?
• Understand how Quality by Design development can be implemented and a robust GMP fundament can be created without creating unnecessary administrative hurdles
• Clinical study concepts for Generics, Hybrid Products and Biosimilars: planning and execution of studies.
• How can the number of studies be limited by application of the Biowaiver concept?
• Overview on the different Marketing Authorisation procedures applicable in the EU and their use for Generics, Hybrid products and Biosimilars
• How should manufacturing process be described in the CMC dossier compared to the GMP documents? What level of detail is required and recommendable?
• How should specifications be established and analytical methods be described in the CMC dossier and in GMP documents?
• How to deal with more recent requirements concerning Elemental Impurities or N-Nitrosamines in CMC or GMP?
• Understand the importance of a well-structured pharmaceutical life-cycle management including the regulatory aspects of variations
• Receive an update concerning impact of upcoming Guidelines to business processes in the areas of Regulatory Affairs and GMP
• Benefit from the long years practical experience of the speaker

Who should attend 

• Individuals involved in risk management planning, risk minimisation development and post authorisation safety studies at small to medium enterprises (SMEs), MAAs / MAHs for generic products, MAAs / MAHs for innovator products and Contract Research Organisations (CROs)
• Risk communication experts
• Qualified Persons responsible for Pharmacovigilance (QPPVs)
• Individuals involved in pharmacovigilance, safety database, signal management and information management

The Trainer:

Dr. Helmut Vigenschow
Senior pharmaceutical consultant and founder of

Mark is a serial entrepreneur and the author of 12 successful IT courses in the Udemy marketplace. His career spans over two decades during which he has been a Founder twice and CTO three times. He has launched two successful lean startups in The Netherlands. Mark became a Microsoft Certified Trainer in 2005 and started training
classes in full stack development. Today he uses his extensive knowledge of IT to help CIOs, CTO s, architects, and forwardlooking tech professionals to make sense of AI, Machine Learning, and Computer Vision. Mark is a certified Microsoft Trainer and Scrum master. He speaks fluent English, Dutch, and German.

Download detailed Agenda - Development of generics: From R&D to GMP MasterClass