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European Biopharmaceutical Review


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News and Press Releases

Stability Testing and Forced Degradation Stress Tests - Proactive Risk Management

Whereas the durability of many consumables, have a strong tendency to decrease, stability is and remains a crucial factor for pharmaceuticals. That is why the identification and elimination of factors, which put long-term stability at risk, is central during development and an important requirement concerning the products quality.
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White Papers

Key to Outsourcing Method Development and Validation: A Pragmatic Approach

RSSL

In an industry that is seeing an increasing level of work being outsourced, the Contract Research Organisation (CRO) of choice needs to have proven experience in both the pragmatism and flexibility of the method developers mind set and a regulatory background in validation. As companies are focussing on achieving ever shorter times of drug to market, it is vital that a tailored, pragmatic approach is adopted when engaging in both method development and validation activities for an Active Pharmaceutical Ingredient (API) or drug product (DP). Although methods still require a high degree of robustness, the overall strategy should encompass a full evaluation of the regulatory requirements applicable to the particular phase of the drug life-cycle; this is pivotal in Key to Outsourcing Method Development and Validation A Pragmatic Approach order to ensure a successful regulatory submission, where the applicant must demonstrate suitable validation of all methods used to support the filing.
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Industry Events

Clinical Trial Supply Europe

11-12 March 2020, Madrid, Spain

The 21st annual edition promises to grow on the success of 2019s excellent conference which saw delegates from Europes largest pharmaceutical companies and biotech innovators come together to discuss, debate and unpack the latest trends in clinical supply chain innovation. 2020 will offer delegates the opportunity to address the growing need for agility within the supply chain in response to increasingly complex trial demands. With a stream dedicated to supply operations and another to innovative uses of technology in the supply chain, delegates will get the chance to gain practical take-aways that they can apply to their own studies.
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