Training OverviewReal-World Data (RWD) has become a fundamental tool for the development and demonstration of the value of any new health technology, through the observation of what happens in real clinical practice. Real-World Evidence (RWE) is a key opportunity to better understand the disease, patient needs, and to improve healthcare processes. RWE promises that a…
WHY ARE WE DIFFERENT?Event scheduleDAY ONE08:40 Connecting to the Online Platform08:50 Greeting from the Project Lead & GLC Icebreaker Session08:55 Opening Remarks from the Chair09:00 Best practices for auditing in the current crisis and beyond09:30 Internal Auditor as Strategic partner10:00 Let’s have a coffee10:20 Co-Presentation: Auditing the operational resilience framework - TRACK A10:20 Internal audit’s strategic…
Training OverviewThis course will help HR professionals to connect to future business reality and take their place at the strategic level decision making concerning talent development. The aim is to give HR business partners a model for the practical implementation of the Learning and Development systems in a remote working environment and inspire strategic thinking…
Training OverviewIt is the course’s goal to inform about the Medical Device Regulation (EU) 2017/745 coming into force on 26th May 2021 and the UDI-marking requirements in Europe and US. Generally, the challenges and solutions how to comply with the requirements of Medical Devices and Unique Device Identification (UDI) in the different markets are core…
Training OverviewTwenty-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 classification, whether it is software as a…
Training OverviewIn 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 data. The course will provide a solid…
Training OverviewThe 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 competencies and strengths. The interactive sessions will…
Training OverviewManufacturing 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 comprises three main steps: (1) Stage 1…
Training OverviewThe 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 processes even outside the R&D or GMP…
Training OverviewIn current environment bank profitability is under heavy pressure, especially in Europe. Negative interest rates, flat interest curve, heavy investment needed for digitalization, competition from Fintech... this is leading bank profitability to historically low levels, and valuations are also suffering since several years. In this context, ensuring adequate pricing of products is a key…
Training OverviewThe training course will support you in collecting, sorting and proper understanding of the requirements of the serialisation Requirements in Brazil, Russia, in Europe, the US and other markets. This includes the relevant information related to the Brazilian Serialisation, the Russian Crypto Coding, the defined two EU-safety features (unique identifier and tamper evident closure)…
IntroductionThe Virtual Leadership in Safety workshop is based upon our multi-award winning Leadership programme, reconfigured to meet the needs of business as a consequence of the Global Coronavirus Pandemic. The virtual workshop takes the lessons and tools shared within our ‘classical’ classroom workshop environment and reinterprets them into an innovative and highly engaging online experience…
Training OverviewFrom the idea to the patient Since 1231, when Friederich II passed the Constitutione Regni Siciliae, (the first medicinal law for Europe) the regulations for medicinal products have changed. The first chemically synthesized APIs in combination with the industrialization beginning 1900, shifted the production of medicinal products from pharmacies to pharmaceutical companies. Meanwhile we…
Training OverviewThe planning, preparation and execution of a turnaround is a complex undertaking that demands an effective strategy, a high degree of control and great attention to detail. It also requires a profound understanding of the critical elements that go to make up a turnaround and the drivers and constraints that shape the event. This…
Training OverviewTechnical 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, and lifecycle of pharmaceutical products. The course…
Training OverviewAnalytical instruments and computerised systems operating in regulated laboratories must be fit for intended use. This is achieved by using a combination of analytical instrument qualification (AIQ) and computerised system validation (CSV). In the current regulatory environment instruments and systems must ensure data integrity and therefore technical controls must be enabled to ensure this…
Training OverviewMost 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 success. Changing this mind set is the…
Training OverviewProject Management is a managerial discipline - with specific processes, tools and techniques - whose importance is increasingly recognized in the Pharma Industry, expecially in R&D, Development and Sales Functions or Divisions. Managers are increasingly called upon to improve their Project Management skills, in research/discovery, preclinical and clinical studies, filing/approval as well as in…
Training OverviewStress 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 will look at examples of impact on…
Training OverviewDo you face challenges to attract or retain talent? An effective L&D strategy will attract and ensure an engaged workforce. An engaged workforce not only goes the extra mile or recommends others to join your company, they are also constantly improving their competencies. If L&D Management can help you overcome this staffing challenge, how…
Training OverviewThe 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 regulatory basis for benefit-risk obligations and frameworks…
Hot topicsThe latest outcomes of the effects of COVID19 on the delay of new product launchCan Price Transparency contribute to more affordable patient access to medicines?Reaching a better integration of regulatory pathwaysA look into the personalized reimbursement systemEarly Payer EngagementEqual access and multi-indication medicinesEvent ScheduleDay one08:30 Joining to the online platform08:45 Greeting from the Project…
Hot topicsImpact of Covid-19 on the Payment InfrastructuresTechnological advancements / FinTech and their eect on the European Payment IndustryTrends and Practices around the world – How fast will they spread?Beyond PSD2 & potential contents of PSD3Event ScheduleDay one08:00 Registration & Networking with Welcome Coffee08:30 Greeting from the Project Lead & GLC Icebreaker Session08:45 Opening Remarks…
Training OverviewHazard 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 that risk assessment are carried out with…