After two drafts and two rounds of comments, it is now here, the new Annex 1. With implementation times of one year or, for individual sections, two years, it gives significantly more time than is usually the case with new guidelines.
Overall, of course, it is much more comprehensive and adapted to today's needs in terms of risk management and oversight strategies, but it also presents users with one or two challenges.
In order to provide information and assistance for a better understanding of the requirements and in the implementation, the ECA and the EQPA, which were also involved in the commenting process as stakeholder organizations, have again scheduled an Annex 1 conference on November 14/15, which will give you the opportunity to get to know the final version in more detail - and also provide you with initial approaches to how these requirements can be implemented in practice.
With 23 contributions from 18 speakers, including one EMA representative, three GMP inspectors, the Chair of the Annex 1 Task Force and the Chair of the CCS Task Force, the conference offers the ideal opportunity to get familiar with Annex 1 and to get answers to still open questions.