Overview About 90% of project management training is about tools and techniques, however most of the job is dealing with the various stakeholders involved in your projects. This series of three master classes are all linked by the engagement of the stakeholders in your projects. Day 1 looks [...]

Overview With an ever increasing regulatory and compliance burden faced by the Pharmaceutical industry, Blockchain is an ideal candidate to address issued across supply chain, clinical trials and R&D. This is happening already with several firms already exploring and developing solutions. This masterclass looks at the technology, the [...]

Overview In today’s highly regulated pharma, biotech, device and animal health industries, it is essential to use the most efficient processes and ensure compliance with an active corrective and preventive action (CAPA) and RCA system. This course will cover CAPA and RCA methodology and documentation, diagnosing process improvement, [...]

Overview Variations are an essential part of pharmaceutical products lifecycle and a critical milestone for the management of post-approval changes. Regulation worldwide is not yet harmonised and this course will help you understand the specific legal framework of variations in Europe. Through practical examples and exercices, you will [...]

Overview Over the past decade, implementing disclosure and data transparency policies and procedures in clinical trials has become an essential requirement for anyone working in this area. Most of the major pharmaceutical companies have already established transparency policies, spontaneously giving the possibility to access the data collected during [...]

Overview The environment for recombinant proteins used as biotherapeutics is changing. In the context of developing new biological entities, the bioindustry should further improve speed to clinic, gain in manufacturing flexibility while reducing costs of good sales (COGS). Despite at start of the recombinant era in the 80s/90s, [...]

Overview Technical and regulatory requirements for developing a medicinal product are becoming stricter every day, the products themselves become more and more complex. This course will present key points in CMC which are currently the focus of Health Authorities, and which are critical for a successful developement, registration, [...]

Overview This 2-day intensive programme is aimed at participants who wish to understand the various legal and practical aspects of commercial contracts in its different facets, and minimise their organisation to exposure to potential expensive disputes, it addresses the background law, key documents including the Joint Venture Agreement, [...]

Overview Analytical chemistry is of major significance in all aspects ofthe pharmaceutical industry. As staff have become more specialist it is important that people without detailed experience in analytical chemistry understand the fundamental principles involved in order to evaluate the data presented to them. This course is intended [...]

Overview The COVID-19 pandemic has significantly impacted the cyber security landscape as threat actors exploit the current crisis by launching an unrelentless barrage of attacks against organisations of all shapes and sizes. To survive, organisations must adopt approaches to cybersecurity that will require more direct engagement from senior [...]