Volume 9A is the guidance documentation for marketed medicinal products for human use in the European Union. It brings together general guidance on the requirements, procedures, roles and activities in this field, for both Marketing Authorization Holders and Competent Authorities of medicinal products for human use and veterinary medicinal products. Volume 9A also incorporates international agreements reached within the framework of the International Conference on Harmonisation (ICH).
Aris Global® is the recognized leader in the implementation of the E2B standard for electronic communication of safety case data. Across the globe, more than 55 customers, including major regulatory agencies, rely on agXchange RSM (Regulatory Submission
Module) for electronically exchanging safety data such as ICSRs, SUSARs, attachments and periodic reports.
agXchange RSM supports the submission of the EVMPD product data as requested by the EMA, which can be easily extended to support the electronic submission of other regulatory data including SPL, PIM and eCTD documents.
As with all Aris Global products, agXchange RSM is available as an on premise as well as an on demand solution on the agOnDemand platform. For over four years, agOnDemand has been providing best-in-class Software-as-a-Service (SaaS) to life science companies to help them meet their regulatory requirements without the pressure of maintaining sophisticated IT infrastructures.
agXchange RSM manages and traces all electronic distribution of regulatory safety submissions and receipts in order to meet complex and often differing regulatory requirements. The application also supports the submission of differing content dependent on the receiver meting local reporting obligations. Other key features include:
agXchange RSM leverages the proven E2B data exchange system from Aris Global, (agXchange ESM) to provide a backbone for the electronic exchange of all regulatory data between internal and external stakeholders. The agXchange electronic exchange platform supports the encryption and decryption of documents, using standard protocols such as AS1 and AS2.