FlyPharma

FlyPharma Conferences and Pharma.Aero are joining together to support a collaborative platform for forward-thinking pharma and cargo professionals at this year’s FlyPharma Conference Europe, with a view to discussing key pharma supply chain challenges affecting all stakeholders.
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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 developer’s 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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Clinical Trial Supply West Coast 2018

23-24 May 2018, Burlingame, CA

Clinical Trial Supply West Coast is returning for its 11th edition to share strategies for improving the efficiency of their clinical supply chain operations. The programme covers a broad range of topics including GMP compliance, transport management software, change control, machine learning, QP release and overcoming customs delays.
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