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 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 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 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 new EU Clinical Trial Regulation (536/2014) will replace the European Clinical Trials Directive (2001/20/EC) in 2022. Key aims of the new Regulation are to harmonise procedures for carrying out clinical trials across the EU and to simplify the clinical trial approval dossier by submission through a new clinical trial database and portal. Guidelines…
Training OverviewThis 2 day intensive practical programme is aimed at participants who wish to enhance their negotiating skills to master the art of negotiating for a range of legal negotiations, including one-on-one and team - on- team negotiations, negotiations with multiple partners, and one-off and continuing negotiations, also negotiating with more powerful counterparts. Learning Outcomes:…
Training OverviewThis public training course will cover the scientific principles of chemical and physico-chemical degradation of active substances and pharmaceutical products as well as the regulatory requirements to establish a retest period or shelf-life. Who should attend? The course will provide practical advice for chemists and pharmacists in the pharmaceutical industry as well as in…
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 OverviewWith regulatory inspectors increasingly finding issues with vendor oversight by sponsor organisations, it is becoming even more important for the pharmaceutical industry to employ efficient and accurate strategies for managing outsourced activities. A company’s ability to identify and select the right CRO/ vendor for the right project and manage them efficientlyandeffectivelywillhelptoensurecompliancewiththeregulator’sexpectations. On this course…
Training OverviewThis course is designed to equip human resources professionals in developing and improving the use of variable pay to support annual business results. While management may oppose raising fixed costs such as base salary and allowances, owners and leaders of organizations generally embrace the use of variable pay which is generally self-funded when designed…
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 OverviewIt is common in our globalized world that, according to their specific and particular strengths and interests more than one pharmaceutical is involved in the marketing of a pharmaceutical product, even in the same geographical area or country. It is crucial and tightly required by the Regulatory Authorities that the safety information arising at…
Training OverviewElectronic delivery of Patient Information (e-PIL) and leaflets (e-leaflets) is becoming increasingly important in providing patients and medical staff with product data. A number of Regulatory Authorities now permit and indeed encourage this delivery mechanism and others are soon to follow suit. Organisations that prepare early will be able to actively leverage the benefits…
Training OverviewThe understanding, development, implementation, follow-up and improvement of the GLP Principles is fundamental for the application of non-clinical health and environmental safety studies. The GLP Principles are mandatory for non-clinical safety testing of test items in pharmaceutical products, pesticide products, cosmetic products, veterinary drugs as well as food additives, feed additives, and industrial chemicals…
Training OverviewMedical device manufacturers have in recent years expanded their product portfolio with digital solutions and added connectivity to their previously standalone devices. Regulatory bodies have kept the pace and updated their regulations to reflect this new reality. What do these new regulations mean for manufacturers making their move into the digital world? When is…
Training OverviewIt is common in our globalized world that, according to their specific and particular strengths and interests more than one pharmaceutical is involved in the marketing of a pharmaceutical product, even in the same geographical area or country. It is crucial and tightly required by the Regulatory Authorities that the safety information arising at…
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 OverviewThe 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 of view in evaluating an RMP. The…
Training OverviewThe new EU Clinical Trial Regulation (536/2014) will replace the European Clinical Trials Directive (2001/20/EC) in 2022. Key aims of the new Regulation are to harmonise procedures for carrying out clinical trials across the EU and to simplify the clinical trial approval dossier by submission through a new clinical trial database and portal. Guidelines…
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.…
Training OverviewThe new EU Clinical Trial Regulation (536/2014) will replace the European Clinical Trials Directive (2001/20/EC) in 2022. Key aims of the new Regulation are to harmonise procedures for carrying out clinical trials across the EU and to simplify the clinical trial approval dossier by submission through a new clinical trial database and portal. Guidelines…
Training OverviewThe Internal audit function is increasingly regarded as a business partner, a catalyst for change and a Governance advisor. You therefore need your 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 provides…