The Electronic Document Management (EDM) Reference Model is intended for biopharmaceutical companies implementing an EDM system or a simple file share to store and prepare documents for regulatory submissions of drugs and biologic products intended for human use. While the model provides the content, a Regulatory Publishing system is still required to assemble and publish a true regulatory submission. The Reference Model is also useful for biopharmaceutical companies needing to organize and transfer documentation assets of a product to another company’s repository under an acquisition or partnership scenario. In this case, the Reference Model provides the common document definition and structure that both companies can share.
March 2019 MMonday TTuesday WWednesday TThursday FFriday SSaturday SSunday 2525-Feb-2019 2626-Feb-2019 2727-Feb-2019 2828-Feb-2019 11-Mar-2019 22-Mar-2019 33-Mar-2019 44-Mar-2019 55-Mar-2019 66-Mar-2019 77-Mar-2019 88-Mar-2019 99-Mar-2019 1010-Mar-2019 1111-Mar-2019 1212-Mar-2019 1313-Mar-2019 1414-Mar-2019 1515-Mar-2019 1616-Mar-2019 1717-Mar-2019 1818-Mar-2019 1919-Mar-2019 2020-Mar-2019 2121-Mar-2019 2222-Mar-2019 2323-Mar-2019 2424-Mar-2019 2525-Mar-2019 2626-Mar-2019 2727-Mar-2019 2828-Mar-2019 2929-Mar-2019 3030-Mar-2019 3131-Mar-2019