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 that risk assessment are carried out with the relevant expertise and knowledge of process safety requirements because inaccurate assessments leads to vulnerability. https://bit.ly/3sHsm3O

Do 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 does a 21st centuryL&D Management look like today? Covid-19 has recently shook us and put us in motion. The learning landscape is evolving: moreand more companies are embracing online learning. Hybrid learning programmes and virtual classrooms are being organised everywhere. Flip learning is knocking at the door as well. The lessons learned from the “voice of the customer”, the war of talent and society changes force us to thoroughly question the traditional learning. But how do you get started? Or how do you reinvent it to stay competitive? And what are the key success factors of a performant L&D Management in this new era? https://bit.ly/2NWVIMT

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 regulatory basis for benefit-risk obligations and frameworks for compliance. Also, we will discuss the fundamentals of benefit-risk assessment, including the different methods and frameworks (i.e. Qualitative and Quantitative) to assess the benefit-risk ratio of each medicinal product. Moreover, participants will have the opportunity to get an insight on real life examples on benefit risk assessment and evaluation and will be able to apply the key concepts learned to conduct a benefit-risk assessment and select the appropriate tools to optimize benefit-risk balance for their products. https://bit.ly/3uQmFCn

This 2 day intensive programme is aimed at participants who wish to understand the various legal aspects of M & A in its different facets, it addresses the deal process, key documents including the Share Purchase Agreement, Disclosure Letter, specific issues Due Diligence in FinTech including Technology, Infrastructure, Material IT components , Cybersecurity, Contract ‘landmines’ with the distinctions between a share purchase and an asset purchase Sample documents will be shared with the participants to study themselves and refer back to them to continue their learning. https://bit.ly/2NOELEx

Management is managerial disipline – 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 launch/sales projects phases, not only to share a method, but also to develop a specific and common culture even with external project partners, especially if international. https://bit.ly/3e4GujB

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 will look at examples of impact on the balance sheet and P&L projections under stress scenarios. Many types of risk can be exposed by stress testing that may not be apparent using only models calibrated to recent historical data. These risks are explored by looking at potential impact on regulatory indicators under stress scenarios. Hence the impact on capital ratios is explored and also the LCR and NSFR indicators of liquidity and the impact of stress scenarios on IRRBB (interest rate risk in the banking book) and the leverage ratio. The course will also consider regulatory guidelines to stress testing and looks at regulatory stress testing exercises, for example, EBA/ECB, Bank of England and DFAST/CCAR. An innovative area of focus on the course will be on coherent approaches to risk aggregation in order to construct an economic capital number based on stressed scenarios. Participants will engage in Spreadsheet-based exercises and also role-playing exercises (live courses only) where time constraints and class sizes permit. Role-playing exercises will be used to practice engagement with a regulator, defending assumptions and responding to likely regulatory challenge. https://bit.ly/384IjZT

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 success. Changing this mindset is the biggest challenge for the audit function. This highly-interactive course will show you how to deliver measurable benefits to your business by : • Focusing audit attention on key business activities which are often not reviewed • Targeting areas of opportunity and added value • Making suggestions for reducing controls for over-managed risks • Delivering a future focussed process • Being seen as a success driver and a catalyst for positive change CPE Credits Participants will earn 14 CPE credits in the Auditing field of study https://bit.ly/387tAxz

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 the successful development, registration, and lifecycle of pharmaceutical products. The course covers general requirements for small molecules and biologics. https://bit.ly/3ebUKXE

Analytical 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 as well as being included within the scope of a CSV project. Regulations, either current interpretations of existing ones or following the issuance of updated ones, allow for risk-based approaches but many laboratories either do not consider this or are held back by ultra conservative quality assurance departments. This course is intended to take a practical and risk-based approach to integrated AIQ and CSV. Instead of automating the status quo any laboratory process should be mapped and redesigned for electronic working by removing spreadsheets and paper printouts. To achieve this requires the implementation of applications that are technically compliant. https://bit.ly/2NVL7BU

The 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 requires involvement of every level of the company from senior management who set the framework for the event through to the craft personnel who perform the actual work. The shutting down and start up phases of a turnaround are critical to the success or failure of the event and as such must be planned and prepared in as much detail as the mechanical phase. The Course is the product of over 30 years of practice by turnaround professionals working in different industries in many countries around the globe and its principles are embodied in the “Model of Excellence for Turnarounds” that forms the central pillar of the workshop. https://bit.ly/3e2N9L0

The 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 in which guests are able to critically consider the issues that support the emergence of a robust safety culture and the actions that safety leaders can take to support this. It is important for guests to understand that this is NOT a typical videoconference! Despite the fact that guests attend from dispersed locations, this is a workshop and, in the spirit of any workshop, attendees are required to ‘roll up their sleeves (virtually!)’ and get involved in discussions, syndicate activities, role plays etc. By taking the time to listen, to learn and to share you will increase your ability to be a positive influence on the culture of safety that you aspire to. Are you ready to commit to making a positive change? https://bit.ly/3uPAe5m

The 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) and the US and International serialisation requirements. Also, this course will deal with the existing and emerging global serialization and track and trace requirements for medicines and their packaging in markets such as China, Korea, US and others. Generally, the business opportunities, the technical possibilities and the challenges of application of Smart pharma packaging and printed are core content of this course. Best practice examples will demonstrate how these topics can be put into practice. This course will also deal with Artwork Security and Audit Trails of Artworks Management. https://bit.ly/3uJkwIV

From 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 have a big variety of laws, regulations and guideline, which accompany the different phases of the approximately 12 year from the first idea until a new medicinal product is available for the patient. This seminar want’s to give an overview of the relevant good working practices and provides the connection to the life cycle of a medicinal product. The main focus here is on the Good development practice, Good Manufacturing Practice and Good Distribution Practice in combination with the life cycle of a Medicinal Products. https://bit.ly/3eac4N3

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 processes even outside the R&D or GMP areas. R&D needs flexibility and should not be over-regulated, whereas GMP concentrates on standardization and high throughput. On the other hand, R&D has to create a solid and robust fundament to enable manufacturing and quality control to work according to established and efficient procedures. The training aims to generate a common understanding of how to best interlink these two areas and create highly efficient processes from product development to routine manufacturing of generic pharmaceutical products. https://bit.ly/3e5qhLc

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 comprises three main steps: (1) Stage 1 – Process Design (FDA) or Process Evaluation (EMA); (2) Stage 2 – Process Qualification (FDA) or Process Verification (EMA); and (3) Continued Process Verification (FDA) or On-going Process Verification (EMA). The training aims to provide deeper understanding on how process validation for biotechnological processes, which is the collection and evaluation of data from the process design stage through commercial production, would be appropriately designed and executed to establish scientific evidence that a manufacturing process is capable of consistently delivering quality product. https://bit.ly/3uMFDtL

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 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 challenge to be able to: • Sustain profitability at an adequate level • Attract most profitable client through tailored offer • Avoid race to nominal profit growth at the expense of long term profitability Developing an adequate Risk Based Pricing practice can be a key advantage. It is a challenge given it lies at the intersection of several skills, namely commercial, financial and risk expertise’s. Pricing a credit goes far beyond comparing a credit spread to the capital consumed, and this course is designed to dig deeper into this hot topic. https://bit.ly/3bajBta

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 competencies and strengths. The interactive sessions will provide practical tools to increase self-confidence. https://bit.ly/3kCJo0i

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 data. The course will provide a solid foundation of machine learning (regression, classification and clustering) and also cover advanced applications like using deep convolutional neural networks to detect objects in images. You will learn how to build advanced AI applications with only a few lines of C# code. We will cover many use cases like trend prediction, anomaly detection,text analysis, computer vision, and many others. During the course Mark Farragher will share many tips and tricks on how you can start introducing AI and data science functionality to your business today. Technology Platform This course uses NET Core version 3.0 and Microsoft Visual Studio Code. Both Windows 10, OS/X, and Ubuntu Linux are supported. The source code of all demos will be made available to participants. https://bit.ly/3q4Yqgo

Key Topics Impact of Covid-19 Impact of Covid-19 on the Payment Infrastructures Technological advancements / FinTech Technological advancements / FinTech and their effect on the European Payment Industry Trends and Practices Trends and Practices around the world – How fast will they spread? PSD2 & PSD3 Beyond PSD2 & potential contents of PSD3 https://bit.ly/2OlV1wj