 Conducting Paediatric Clinical trials
This 2-day course provides you with practical, step-by-step guide to running clinical trials for paediatric populations. It features the latest updates on the regulations and, more importantly, the practical implications these will have. The course also focuses on clinical trial design, PIPs, patient recruitment and retention, meaning you will be able to return to your organisation with all the skills needed to run a successful peadiatric clinical trial.
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 Laboratory Equipment Qualification
This training course provides hands-on techniques for qualifying equipment. By
attending this course you will learn how to prepare and complete equipment
qualification protocols for drug products and related industries, such as drug devices and diagnostics, pharmaceutical biotechnology and bulk pharmaceutical chemicals.
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 The Pharma Executive Mini-MBA
This popular, highly interactive and practical programme has
been specifically designed by experts in business and management
development from the pharmaceutical sector. Over the course of five
days it will equip you with key management skills and the
intellectual capital needed to be a high performance manager in this
industry. The aim of the ‘Pharma Executive Mini-MBA’ is to harness
not just the experiences of our presenters, but where relevant the
participants. The programme offers you the opportunity to meet and
share practical experiences with other managers from across the
international pharmaceutical sector. The ‘Pharma Executive Mini-
MBA’ consists of five modules based on the key areas of the MBA and
tailored to develop the specific management skills required within
the pharma sector. It is particularly beneficial to attend with a
colleague to maximise the practical learning.
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 Introduction to Regulatory Affairs for Medical Devices
This practical 2-day introductory level training course will examine the complex processes involved in meeting the EU regulatory requirements associated with Medical Devices.
From early decisions regarding the most appropriate conformance route of a product, through to post marketing adverse event reporting, delegates will learn which regulations directly apply to their product and what steps need to be taken to achieve full compliance and ensure patient safety.
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 Regulatory Affairs for Veterinary Medicines
This 2-day practical course is designed for the regulatory professional to give a complete guide to the regulatory guidelines surrounding the authorisation of veterinary medicinal products. As the market for veterinary products grow, so too do the requirements for regulatory compliance on a global scale. The course will focus on the Directive 2004/28 and its impact on your marketing applications in an enlarged Europe
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 Introduction to European Regulatory Affairs
The course will focus on understanding the European legal & regulatory environment, the registration procedures that are available and the structure of the registration dossier
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 Environmental Risk Assessment of Human Pharmaceuticals
This course will give a practical and in-depth understanding of environmental risk assessment for human pharmaceutical products. It will cover the full process from the initial evaluation at Phase I, design of the testing programme through to the preparation of the environmental risk assessment.
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 Biocidal Products Directive
This is a practical workshop designed for anyone involved in the registration of biocides either at EU or national level. With the introduction of the Biocidal Products Directive (BPD) many more products will require authorization where in the past they may have few if any regulatory controls. For example in countries like the UK products such as disinfectants, water treatment biocides, preservatives and household cleaners that make biocidal claims will fall within scope of this legislation where in the past they were not specifically controlled.
This course is designed to introduce delegates to the BPD and to look at data requirements, efficacy testing, ecotoxicology, environmental fate, toxicology and the associated risk assessment. It also covers some practical aspects of dossier preparation and submission.
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 Regulatory Affairs for Phase I Clinical Trials
-Gain the knowledge necessary to reduce the likely hood of your product being withdrawn after going to market
-Understand the role of the regulatory bodies
-Investigate the advantages and disadvantages of using a CRO
-Travers the mine field which is the documentation necessary for submission for approval of your phase I clinical trial
-Successful strategies to ensure compliance with current regulatory affairs
-Overcoming the challenges of selecting a centre to perform your phase I clinical trials
-Optimise and maintain your regulatory procedures for phase I clinical trials within the EEA
-Understand the changes to the EU directive for phase I clinical trials to ensure compliance
-Identify the factors which influence approval by the regulatory bodies
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