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 The global nanomedicine market was reported to be worth $70 billion by 2011, $140 billion in 2016 and is predicted to be worth $350 billion by 2025. To take advantage of the many opportunities that lie ahead and to be successful in a market that will become [...]
Overview The global synthetic (constructive) biology market is anticipated to reach $30.3 B by 2027 growing at a CAGR of 23.6% during the last 7 years of the investigated period. Private investment in startups is increasing rapidly and added up to over $12 B in the last decade. [...]
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 Manufacturing processes should be validated prior to initiate commercial manufacturing. Regulatory bodies expect that the manufacturer understand the process so that quality, safety and efficacy of the product are designed or built into the product through the appropriate control of each manufacturing process steps. Today, process validation [...]
Overview The In vitro Medical Devices Directive has been the route to CE marking of in vitro medical devices in Europe since 2002. In 2017 the new In Vitro Medical Devices Regulation (IVDR) was published and comes into force in May 2022. From this moment all IVDs must [...]
Overview In this MasterClass, the different steps that are requiered to generate a pertinent genetically engineered model will be detailed and explained. What is the purpose of a specific design? What does a conditional model mean? Is it better to fuse a reporter in N- or C-term of [...]
Overview The training course will support you in collecting, sorting and proper understanding of the requirements of pharma and healthcare packaging, the US Healthcare and Pharma Market, the global serialization requirements in the US, in Brazil, Russia, Europe and other markets and the technical implementation at the pharmaceutical [...]
Some of the hot topics The interface between Development and GMP units is one of the most exciting in the pharmaceutical industry. Mutual understanding of the different regulatory environments and the functional priorities is a key success factor. Conflicts, mostly resulting [...]
Overview The introduction of the Quality by Design concept in the early 2000’s has changed the paradigm of product and process development for recombinant biotherapeutics, switching from the process makes the product to the product makes the process. The Quality by Design approach starts by the understanding of [...]
