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)…
Training OverviewThis 2-day intensive programme is aimed at participants who wish to understand the various legal and practical aspects of commercial contracts in its different facets, and minimise their organisation to exposure to potential expensive disputes, it addresses the background law, key documents including the Joint Venture Agreement, R&D Agreement, Commercial Manufacturing Agreement, Collaboration structures,…
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 OverviewThis 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…
Training OverviewThe COVID-19 pandemic has significantly impacted the cyber security landscape as threat actors exploit the current crisis by launching an unrelentless barrage of attacks against organisations of all shapes and sizes. To survive, organisations must adopt approaches to cybersecurity that will require more direct engagement from senior executives to protect critical business information and…
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…
Training OverviewOver the past decade, implementing disclosure and data transparency policies and procedures in clinical trials has become an essential requirement for anyone working in this area. Most of the major pharmaceutical companies have already established transparency policies, spontaneously giving the possibility to access the data collected during their clinical trials to anyone who requests…
Training OverviewThe environment for recombinant proteins used as biotherapeutics is changing. In the context of developing new biological entities, the bioindustry should further improve speed to clinic, gain in manufacturing flexibility while reducing costs of good sales (COGS). Despite at start of the recombinant era in the 80s/90s, continuous upstream processes have been applied especially…
Training Overview2020 was a stark reminder of just how unpredictable the world is. As events unfolded and policy makers responded it was necessary for banks and other economic agents to continuously update their outlook on how the economy would respond. Markets initially lurched downwards, stocks, commodities and interest rates but then started to look through…
Training OverviewInternational assignments can be physical or remote. This course has been designed to equip HR professionals to understand and effectively support business and talent outcomes, when moving talent or work across borders. Traditional expatriate assignments, permanent transfers, localization and local employment of foreign talent will be covered, from both global and local perspectives. Virtual/remote…
Training OverviewAs healthcare shifts from “volume to value” we are seeing a global trend of shifting medicines and technology pricing towards a value based paradigm. This comprehensive symposium will cover off “value based agreements” and innovative financial contracts between pharmaceutical manufactures and payers. We will go through VBA nomenclature through to design and architecture of…
Training OverviewAbout 90% of project management training is about tools and techniques, however most of the job is dealing with the various stakeholders involved in your projects. This series of three master classes are all linked by the engagement of the stakeholders in your projects. Day 1 looks a risk analysis and alongside the traditional…
Training OverviewEvery compensation & benefits manager must know how to manage the annual salary review, and less experienced C&B specialists also must be able to support it. This course equips C&B professionals to competently perform their most important annual project, the annual salary review. The course covers pay for performance theories, salary budgeting, use of…
Training OverviewHealthcare landscape is changing drastically due to the emergence of new technologies. Treatment is diverging from the general applications paradigm we were subjected in the past to a personalization for each patient and each disease type. This course will present a general overview on precision medicine with several case studies of the newest approaches…
Training OverviewHow would you know if fraud was occurring in your organisation? Does your organisation have a fraud prevention strategy? Do you have a formal programme to tackle the risk posed by fraud? Do you have the use of any automated fraud detection techniques? If fraud is suspected do you have a clearly defined approach…
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 OverviewMany companies and their directors / senior individuals may not be fully familiar with their Health and Safety duties and the way in which changes to Health & Safety legislation (both in the UK and abroad)might impact them. This highly engaging and interactive seminar will highlight the key health and safety risks for companies…
Training OverviewVariations are an essential part of pharmaceutical products lifecycle and a critical milestone for the management of post-approval changes. Regulation worldwide is not yet harmonised and this course will help you understand the specific legal framework of variations in Europe. Through practical examples and exercices, you will learn to define the best submission strategy,…
Training OverviewRoot cause analysis (RCA) is a regulatory requirement for regulated companies in the pharmaceutical industry. According to ICH Q10, companies should have “a system for implementing corrective actions and preventive actions resulting from the investigation of complaints, product rejections, non-conformances, recalls, deviations, audits, regulatory inspections and findings, and trends from process performance and product…
Training OverviewWith an ever increasing regulatory and compliance burden faced by the Pharmaceutical industry, Blockchain is an ideal candidate to address issued across supply chain, clinical trials and R&D. This is happening already with several firms already exploring and developing solutions. This masterclass looks at the technology, the opportunities it offers, the risks and issues…
Training OverviewNowadays, for as much as 95% of the 7 000 to 10 000 rare diseases that exist, there are no approved therapies. Of the estimated 400 M people worldwide afflicted with a rare disease, 50% are children. Cell and gene therapies have emerged as a new treatment paradigm for many rare diseases. These novel…
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…
Training OverviewFor well over a decade interest rates have been trading at ultra low and even negative levels. It would seem likely that at some stage interest rates will rise, resulting in a fall in bond rices. This course considers some of the tactics that could be used to hedge the associated market and credit…
Training OverviewThe Internal audit function is increasingly regarded as a business partner, a catalyst for change and a Governance advisor. You therefore need your internal audit function to become a trusted advisor and internal consultant. The course represents a superb opportunity to develop new approaches to the difficult challenges facing modern audit functions and also…
Training OverviewThis course covers thet heory and practice of Blockchains/Distributed Ledger Technology. It is based on the trainer’s extensive background as both an educator,consultant and advisor to numerous blockchain initiatives. The online course has been developed for business executives, leaders and managers. It provides far more than just an understanding of the technology. It provides…
Training Overview• In this time of global uncertainty how do you steer a course through these difficult waters? • The answer is to anticipate, manage and then deal with the risks at an enterprise level. • Most organisations have now realised that much more is needed and have developed an Enterprise Risk management (ERM) approach.…