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Autumn 2020

   
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News and Press Releases

ynparza approved in Japan for the treatment of advanced ovarian, prostate and pancreatic cancers

Approvals based on the PAOLA-1, PROfound and POLO Phase III trials
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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 developerís 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

12th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology

8-11 February 2021, Vienna, Austria

In continuation of the very successful scientific meetings in Budapest, Paris, Berlin, Florence, Geneva, Barcelona, Malta, Istanbul, Lisbon, Glasgow and Granada, the 12th PBP World will be held in Vienna from 8-11 Feb 2021. This every two year held conference has gained an ever increasing impact among the pharmaceutical scientists: With up to 1000 submitted abstracts and about 1300 participants it has become a well-established major meeting, attracting scientists from all over the world.
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