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 [...]

Overview From the idea to the patient Since 1231, when Friederich II passed the Constitutione Regni Siciliae, (the first medicinal law for Europe) the regulations for medicinal products have changed. The first chemically synthesized APIs in combination with the industrialization beginning 1900, shifted the production of medicinal products [...]

Overview The training course will support you in collecting, sorting and proper understanding of the requirements of the serialisation Requirements in Brazil, Russia, in Europe, the US and other markets. This includes the relevant information related to the Brazilian Serialisation, the Russian Crypto Coding, the defined two EU-safety [...]