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 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 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 OverviewThe increasing demand for digitalization is currently challenging large to small sized company globally and hardly any company can ignore the digitalization trends today. This masterclass will provide delegates clarity of which prerequisites need to be considered to prepare for the demanding task. This course will provide examples to digitalization mysteries in compensation management.…
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 OverviewThe Contract and legal document drafting seminar is an intensive training event for lawyers, and paralegals,working in the the pharmaceutical industry, held over 4 consecutive half-day sessions. It will improve participants’ skills of writing clear, concise contracts with specific relevance to the pharmaceutical Industry, including collaborative research agreements, joint-venture agreements, IP rights and key…
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 OverviewThis 2 day programme is intensive, and 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 Life Sciences including IP, IT and Regulatory Warranties in Life Sciences…
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 OverviewThe direct interaction between patients / users of pharmaceutical products and the Pharmaceutical Companies has had a big increase since the widespread use of the Internet and social media. In parallel, the requirements of the competent authorities towards the exhaustive collection and management of any adverse events related to the products marketed by the…
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 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 OverviewDigital health has grown exponentially as governments and other payers grapple with how to provide the best possible health outcomes at affordable costs. We believe that every healthcare decision should be informed by the best scientific research derived from rigorous, proven methodologies. In today’s world, healthcare decision makers across the globe are often faced…
Training OverviewThe introduction of the Quality by Design concept in the early 2000’s has changed the paradigm of product and process development for recombinant biotherapeutics, switching from the process makes the product to the product makes the process. The Quality by Design approach starts by the understanding of the impact of changes in quality attributes…
Training OverviewThe course aims to explain the legal and compliance background to risk management, before considering in a non-mathematical way the core principles and processes of managing risk. Case studies will be used and the emphasis of the course is on developing a comprehensive understanding of the subject and its terminology. Who should attend? Risk…
Training OverviewThe last year has seen even more internal auditors and review teams adapt to the realities of working remotely. We have had to conduct business-critical internal audit engagements and reviews while working away from our desks, distant from our clients and from our management. These engagements may have been part of the annual or…
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 global nanomedicine market was reported to be worth $70 billion by 2011, $140 billion in 2016 and is predicted to be worth $350 billion by 2025. To take advantage of the many opportunities that lie ahead and to be successful in a market that will become more and more competitive requires an understanding…
Training OverviewThe In vitro Medical Devices Directive has been the route to CE marking of in vitro medical devices in Europe since 2002. In 2017 the new In Vitro Medical Devices Regulation (IVDR) was published and comes into force in May 2022. From this moment all IVDs must comply with the new IVDR. At the…
Training OverviewThe training course will support you in collecting, sorting and proper understanding of the requirements of pharma and healthcare packaging, the US Healthcare and Pharma Market, the global serialization requirements in the US, in Brazil, Russia, Europe and other markets and the technical implementation at the pharmaceutical manufacturer. This course will deal with Child…
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 OverviewGenome editing has revolutionized our ability to modify the genome of (quite) any biological organism. In particular, it opens up new possibilities for the treatment of various diseases in humans like rare genetic diseases, cancer or HIV. Today, what alterations can we really achieve? What risks can we anticipate and how to check for…
Training OverviewThe global synthetic (constructive) biology market is anticipated to reach $30.3 B by 2027 growing at a CAGR of 23.6% during the last 7 years of the investigated period. Private investment in startups is increasing rapidly and added up to over $12 B in the last decade. In 2018, synthetic biology companies raised a…
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 OverviewIn this MasterClass, the different steps that are requiered to generate a pertinent genetically engineered model will be detailed and explained. What is the purpose of a specific design? What does a conditional model mean? Is it better to fuse a reporter in N- or C-term of a protein? Should we use IRES (Internal…
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 OverviewEnvironmental, Social, Governance (ESG) investing is gaining traction as mainstream players are now considering the financial and risk management benefits of adhering to some form of ESG integration and monitoring, while at the same time find the need to respond to the increasing demand forresponsible investments that come from millennials and the need to…
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 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 OverviewTo ensure that therapies for serious conditions are approved and available to patients as soon as it can be concluded that the therapies’ benefits justify their risks, regulatory agencies have developed specific processes to speed the availability of new therapies, especially when there are no satisfactory alternative therapies, while preserving appropriate standards for safety…
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.…