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| home > white papers > Challenges of Analytical Method Transfer in the Pharmaceutical Industry - RSSL |
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 WHITE PAPERS |
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RSSL
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+44 (0)118 918 4024
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http://www.rssl.com
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University of Reading, Whiteknights Rd, Reading, West Berkshire RG6 6LA
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Challenges of Analytical Method Transfer in the Pharmaceutical Industry
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The development and validation of suitable analytical methods is a critical part of the overall drug-development life-cycle. For the majority of products, particularly those that are clinically successful, the transfer of the analytical method between laboratories will be required. This process is designed to verify that a given laboratory is capable of performing a test method for its intended purpose. This can be performed either internally (at the same company), or, with the on-going increasing trend in outsourcing, to an external Contract Research or Development organisation (CRO or CDO).
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News and Press Releases |
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Huge boom in Korean Pharma reported at CPhI Korea
Amsterdam, 19th September 2019: The recently-closed CPhI Korea – co-organised by Informa Markets and the Korea Pharmaceutical Traders
Association (KPTA) – has seen a surge in growth across domestic and
international pharma companies, as well as a sizable rise in overall
attendees. As reported earlier this year in the provisional findings of
the CPhI Pharma Index[1], Korea has seen a rapid growth in its
international reputation (seeing its ‘overall competitiveness’ rise 14%
in the last two years), which is now translating into a sizable growth
in the market and at the event.
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White Papers |
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7 Common Myths about QP Training Debunked: A Guide for Senior Managers
RSSL
The role of the Qualified Person (QP) in the pharmaceutical industry is mandated by law (Directive 2001/83/EC, Directive 2001/20/EC, UK SI 2012/1916, UK SI 2004/103). Every holder of a relevant Manufacturers Authorisation (human and veterinary) must have at least one QP; without one, no batch of medicinal product can be certified for release for sale.
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Industry Events |
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Clinical Operations in Oncology Trials West Coast
17-18 November 2020, Hilton San Francisco Airport Bayfront
Clinical Operations in Oncology Trials West Coast will be returning this April for another 2 day event full of thought-provoking presentations, discussions and roundtables. This years' conference highlights include the high-level, interactive immuno-oncology discussion panel where specialists from Shasta Bio Ventures, Abbvie and BeiGene shared their top tips on how to run successful and impactful immuno-oncology studies.
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