The inevitable progress of electronic dossiers becoming a mandatory requirement for regulatory submissions has been evolving in many Health Authorities in recent years. The common requirement for submissions in eCTD (electronic Common Technical Document) is now well established in the EU, and will impact herbal medicines with Marketing Authorisations and Traditional Herbal Medicines.
This seminar aims to explain the mystery of an eCTD, focusing on the technical requirements, and providing practical advice on how to build and publish submissions to the required standard expected. It will also consider the advantages and disadvantages in outsourcing such operations to an external provider.
EXTEDO experts will support this event with a presentation on eCTD.
This seminar is open to both BHMA members and non-members. Click here to book.