Registration and variations
Interdisciplinary understanding and an optimized communication are core aspects for the achievement of common goals. 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.
After the first approval changes (variations) are coming up due to several reasons. Unterstand the needs and the timelines
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 productSystem of Rules and Authorities
Requirements of Medicinal Products and APIs
Common Technical Document
Marketing Authorisation applications and CE Certification
CP, MRP, DCP in Europe
Marketing Authorisation procedure in Switzerland
NDA, ANDA in USA
Format and content
Variations and Change Control
ASMF and CEP for APIs
Difference in the regions
Registration and GMP