Registration and success of the company
The insight into different departments and the overview on the regulatory requirements is often difficult due to the required high specialization in the companies. The knowledge about the overall process, however, is important for the individual as well as for the success of the whole company. 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 are delivering data for the registration dossier. Therefore personnel from all areas should have a basic knowledge about the regulatory requirements. When dealing with changes after the first approval of a product personnel from a number of departments outside Regulatory Affairs are important to keep the regulatory compliance.
API manufacturers, Excipient manufacturers and Service Providers can benefit from a basic knowledge in regulatory requirements. It guaranties an optimal service for the pharmaceutical industry.
ProgrammeThe route from Research to an approved productSystem of Rules and Authorities
Requirements on Medicinal Products and APIs
Common Technical Document
Marketing Authorisation applications and CE Certification
MRP, CP, DCP in Europe
NDA, ANDA in USA
Format and content
Variations and Change Control
ASMF and CEP for APIs
Difference in the regions
Phytopharmaceuticals and homeopathic products
Registration and GMP
Registration in the day to day work