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 [...]
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 [...]
Introduction In current environment bank profitability is under heavy pressure, especially in Europe. Negative interest rates, flat interest curve, heavy investment needed for digitalization, competition from Fintechs... this is leading bank profitability to historically low levels, and valuations are also suffering since several years. In this [...]
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 [...]
Overview Digital health has grown exponentially as governments and other payers grapple with how to provide the best possible health outcomes at affordable costs. We believe that every healthcare decision should be informed by the best scientific research derived from rigorous, proven methodologies. In today’s world, healthcare decision [...]
Overview The course aims to explain the legal and compliance background to risk management, before considering in a non-mathematical way the core principles and processes of managing risk. Case studies will be used and the emphasis of the course is on developing a comprehensive understanding of the subject [...]
