Nearly all departments are involved in the preparation of documents or deliver data for the registration dossier. Therefore, personnel from all areas should have a basic knowledge of the regulatory requirements.
API manufacturers, excipient manufacturers and service providers can benefit from a basic knowledge of regulatory requirements. It guarantees an optimal service for the pharmaceutical industry.
ProgrammeThe route from research to an approved productRegistration procedures
Common Technical Document
Marketing Authorisation applications and CE Certification
MRP, CP, DCP in Europe
Format and content
ASMF and CEP for APIs