Some of the Learning Outcomes Learn more about group sequential methods Understand where DMCs are useful/not useful Take a closer look on how do DMC meetings run Understand legal position/indemnity CHMP, FDA (and other) guidance documents Stopping ‘rules’, including Haybittle and Peto, Pocock, O’Brien and Fleming, alpha-spending approaches, [...]
Overview Climate change is increasingly on the agenda as a material risk, not just for the long-term but as a current issue. Global climate science continues to highlight observable changes in the climate, with increasing evidence of physical effects and accelerating impacts of the effort to transition to [...]
Overview Recent advances in human error management based on alertness creation dovetail seamlessly with holistic and coordinated approaches to risk management. This two day course covers the recent advances in understanding why people make physical and cognitive mistakes and what pro-active and proportionate steps can be taken to [...]
Why should you attend? Writing effective audit reports must be the most important aspect of the Internal Audit process. It is the main deliverable and the way your whole audit is judged. Why then does this often seem to be such a difficult process? Is it because [...]
Overview Twenty-five years ago, software did not feature significantly in medical device legislation. Thirteen years ago it was added as a serious afterthought. As Europe moves to the new Medical Device Regulations, software is recognised throughout the General Safety and Performance Requirements. It has its own rules in [...]
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 [...]
2nd Annual Pharma Digitalization Forum The 2nd Annual Pharma Digitalization Forum organized by GLC Europe will provide a great opportunity for learning and networking during the 2 days of the event. The goal of the conference is to uncover the insights of the most emerging best [...]
Overview It is the course’s goal to inform about the segment of Smart packaging and printed electronics in the field of pharmaceutical packing in Europe, in the US and globally. Generally, the business opportunities, the technical possibilities and the challenges of application of Smart pharma packaging and printed [...]
Overview Recent advances in human error management based on alertness creation dovetail seamlessly with holistic and coordinated approaches to risk management. This two day course covers the recent advances in understanding why people make physical and cognitive mistakes and what pro-active and proportionate steps can be taken to [...]
Overview The focus of this two days training will be on providing an update of ongoing activities regarding medicines’ risk and signal management. The first day will be an opportunity to provide the participants with practical advice on RMP drafting and preparation as well as the accessor's point [...]
