Introduction 2020 was a stark reminder of just how unpredictable the world is. As events unfolded and policy makers responded it was necessary for banks and other economic agents to continuously update their outlook on how the economy would respond. Markets initially lurched downwards, stocks, commodities [...]
Overview The Contract and legal document drafting seminar is an intensive training event for lawyers, and paralegals,working in the the pharmaceutical industry, held over 4 consecutive half-day sessions. It will improve participants’ skills of writing clear, concise contracts with specific relevance to the pharmaceutical Industry, including collaborative research [...]
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 last year has seen even more internal auditors and review teams adapt to the realities of working remotely. We have had to conduct business-critical internal audit engagements and reviews while working away from our desks, distant from our clients and from our management. These engagements may [...]
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 [...]
