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Analysing and Drafting Commercial Contracts in Life Sciences MasterClass

17 May - 18 May

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,…

Advanced CMC MasterClass

19 May - 20 May

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…

Best practices and tools for Pharma Project Management MasterClass

20 May - 21 May

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…

Advanced Pharma Cybersecurity Risk Management and Audit MasterClass

25 May - 27 May

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…

Benefit-Risk Assessment in Pharmacovigilance MasterClass

27 May - 28 May

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…

Data Transparency in Clinical Trials and Fake News MasterClass

14 June - 15 June

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…

Continuous Manufacturing Processes for Biotechnological Products MasterClass

16 June - 17 June

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…

Analysing and Drafting Commercial Contracts in Life Sciences MasterClass

02 August - 03 August

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,…

VBA & Innovative Contracting in Pharma MasterClass

23 August - 25 August

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…

A stakeholder engagement approach to Clinical Trials MasterClass

01 September - 03 September

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…

Pharma Mergers and Acquisitions MasterClass

02 September - 03 September

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…

Advanced Precision Medicine MasterClass

07 September - 08 September

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…

Advanced CMC MasterClass

14 September - 15 September

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…

Pharmacovigilance on the Internet and Social Media MasterClass

14 September - 16 September

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…

How to submit variations in Europe MasterClass

16 September

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,…

Advanced Pharma Root Cause Analysis MasterClass

21 September - 22 September

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…

Blockchain for Pharmaceuticals MasterClass

22 September - 23 September

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…

Unlocking the Potential of Cell & Gene Therapies MasterClass

23 September - 24 September

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…

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