Optimal Validation Design
Before undertaking a validation attempt of an analytical method, it is important to think about the experimental design. In this white paper we go into some theoretical aspects and requirements needed to estimate the optimal experimental design from a cost vs. risk perspective. As a starting point and principle we use the Total Analytical Error (TAE) which we believe is the future of analytical method validation, and which is also slowly getting its way into the governing guidelines of analytical method validation such as ICH Q2(R2), ICH Q14 and USP <1220>.
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DownloadSolving the Life Sciences Innovation Dilemma with an Integrated Product Development Strategy
Integrated product development (IPD) is a strategy that promotes the integration of multidisciplinary teams as part of the development process. It leverages a holistic approach to achieve key objectives of improved efficiencies, shortened timelines and reduced costs in bringing a product to market succeeding by involving all functional team members early in the development process.
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DownloadTransport risk assessment and verification - from theory to practice.
Legal and regulatory requirements, including GMP and GDP guidelines, require consistently that medicinal products shall be stored and transported in a way that the product delivered maintain their quality and integrity and remain within the legal supply chain during storage and/or transportation. Storage and transport need to be described in the Pharmaceutical Quality System and the principles of quality risk management shall be used for designing and managing these activities.
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DownloadPharma's growing interest in probiotics - a challenge or an opportunity?
According to the US FDA definition, probiotics are classified as Live Biotherapeutic Products (LBP) i.e. products that contain live organisms such as bacteria or yeast, found naturally in humans. The most common bacteria belong to the groups Lactobacillus and Bifidobacterium. Probiotics have a long global history of traditional use. Normally consumed through fermented foods and sold mostly as ingredients in foods or nutritional supplements. There is a thin line between nutritional supplements and drugs.
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DownloadThe medical device regulations and their implications on device vigilance
Download our recent whitepaper to gain deep insights into the medical device regulations and their implications on device vigilance.
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DownloadPreparing for a Good Pharmacovigilance Practice MHRA Inspection
Download our recent whitepaper to gain deep insights into preparing for a Good Pharmacovigilance Practice MHRA Inspection.
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DownloadUK Pharmacovigilance Requirements Following the End of the Brexit Transition Period
Download our recent whitepaper which introduces you to the most important UK pharmacovigilance requirements following the end of the Brexit transition period.
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DownloadNon-clinical safety evaluation of vaccine: strategic considerations to accelerate clinical development
Download our recent whitepaper on Non-clinical safety evaluation of vaccine and gain valuable insights about the step-wise process comprising preclinical proof of concept, non-clinical development (efficacy, quality, and safety), and clinical development of a vaccine.
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DownloadHow will Medical Devices be regulated following the end of the Brexit Transition Period
This whitepaper summarises the key elements of MHRA’s guidance document on medical devices, regarding registration, assessment procedures, labeling, post-market surveillance, and vigilance that will apply for devices placed on the market in Great Britain (England, Wales, and Scotland) and Northern Ireland. This document provides a list of actions that manufacturers of medical devices should take in order to continue the placement of their products on the EU and UK markets.
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DownloadBrexit Considerations for Industry: The current Position
The UK formally left the EU on 31st January 2020 and the transition period, as set out in the withdrawal agreement, will come to an end on 31st December 2020. During this transition period the UK has continued to remain under EU pharmaceutical law. Our PharmaLex.perts have created an interesting Whitepaper, which introduces you to important current considerations about Brexit for the industry.
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DownloadNitrosamines - information for MAHs
This paper gives details on the background and recommended steps required to ensure your medicinal products comply with the latest guidance for nitrosamines.
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DownloadManage effectively your Merger and Acquisition activities
Companies engaging in Merger and Acquisition (M&A) activities aim to gain momentum by undertaking one or a combination of the following to: Level of Regulatory Affairs Involvement with M&A Programs, Increase market share by consolidating their product portfolio into specific therapeutic areas, Replenish their previously dwindling product pipeline, Enter into emerging markets with existing and new products, Reduce costs through the consolidation of manufacturing sites.
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