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Drug Manufacturing

 

webinar

Understanding the complexities of global serialisation & traceability regulations

18 September 2018 | By Clarivate Analytics

In 2017 the WHO estimated that the counterfeit drug market represents around 10-15 percent of the pharmaceutical market worldwide, with an estimated $200bn revenue per year. Worldwide there were 3,509 pharmaceutical crime incidents in 2017, which represents an 11% increase from 2016. Most falsified medicines that reach the market do…

webinar

Understanding current CFR 21.11 and data integrity requirements

8 August 2018 | By SUEZ

The US FDA and European Commission have defined regulations relating to the submission of electronic records in lieu of paper documents, for submission, inspection, and archiving purposes. When ageing analytical equipment is to be replaced 21CFR Part 11 and EU Annex 11 are also topics of discussion. Common questions from…