Overview Hazard identification and risk assessment plays a pivotal role regarding managing risks associated with workplace and process safety. They form the foundation for process safety management activities. Once hazards have been identified and associated risks assessed, the acceptability of the risk can be judged. It is critical [...]
Overview The focus of this training will be on providing an update of ongoing activities regarding the benefit risk assessment throughout the lifecycle of a medicinal product. We will discuss the comprehensive framework on benefit-risk of medicinal products and participants will learn about the main principles, legal, and [...]
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 Stress testing has become an important tool for risk management and a key part of the regulatory framework. This course discusses various approaches to generating stress scenarios, simple ‘what-if’ scenarios and simulation techniques through to the use of full structural macroeconomic models of the global economy. It [...]
Overview The interface between Development and GMP units is one of the most exciting in the pharmaceutical industry. Mutual understanding of the different regulatory environment and the functional priorities is a key success factor. Conflicts, mostly resulting from different approaches and priorities, can have negative impact on business [...]
Overview In this 2-day training you will learn how to build machine learning applications in C# with Microsoft’s new ML.NET library. You will learn how to prepare a data set, load and process it, and design and train a machine learning model to generate useful predictions from the [...]
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 Today we can no longer afford to undertake randomized effectiveness trials that cost tens or hundreds of millions of dollars. But today we also have registries and other powerful digital platforms. Today it may be possible to design and conduct megatrials with what we have: bigger data [...]
Overview The programme will take the group on a journey of self-discovery and self-mastery. It will enable participants to understand and leverage their core strengths to become authentic leaders and role-models who empower others. Participants will develop leadership and coaching skills, confidence, self-awareness and understanding of their core [...]
Overview Most Heads of Internal Audit would say that their functions have adopted a risk-based approach. Why then is Internal Audit often seen as negative and unhelpful, a function that points out errors and focusses on finding fault? Is it because it focusses mainly on failure rather than [...]
