Graham Cook PhD - Articles and news items

Wyeth’s PAT variations submitted through the EMEA Worksharing Procedure

Issue 3 2008, Past issues / 19 June 2008 /

In June 2006, the EMEA called for nominations from companies to participate in the pilot phase of a worksharing exercise for Quality variations1. Worksharing is a key element in the revisions to the variations proposed by the European Commission, which are intended to streamline the process for making changes to Marketing Authorisations, reducing the regulatory burden and encouraging innovation2. The worksharing procedure is intended where variations to the same nationally authorised product are submitted to the different National Competent Authorities (NCAs). All NCAs are eligible i.e. potentially all 29 EU/EEA states could be involved in the procedure.

Wyeth forges ahead

Issue 5 2006, Past issues / 28 September 2006 / Graham Cook Ph.D., Director Technology and External Supply, EMEA, Wyeth

Is the pharmaceutical manufacturing environment of today becoming more challenging? There is increasing pressure to control or reduce costs because of the limitations on healthcare budgets. Asset utilisation, operating efficiencies and cycle times in the pharmaceutical industry generally compare unfavourably with other high technology industries. Despite the resources invested in compliance, many companies continue to struggle to meet the regulatory requirements, as evidenced by warning letters and consent decrees.


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