Enterprise Standards 1 – 3: a practical 5-day Workshop (Max 4 delegates).
The Quad Pharma course Medicine Registration Basic (EUS) 1 – 3 is a short course that encompasses the fundamentals of Medicine Registration and is a suitable starting point for all CTD (Common Technical Document) based applications. It is the foundation for the two accredited short courses Medicine Registration for Orthodox Medicines (EUS 4) and Medicine Registration for Biological Medicines. (EUS 5), and is the appropriate course for pharmacists wishing to embark on a career in Regulatory Affairs.
Requirements for entry
- Qualified Pharmacist who may or may not already be employed in the Pharmaceutical Industry.
- Regulatory Scientist with a BSc. Degree: Must already be employed in the pharmaceutical industry
- This course is not open to Pharmacist Assistant Basic or Post-Basic. The appropriate Training course for this category is the course Medicine Registration For Registration Assistants.
It is a very intensive practical course designed for the newcomer or the person with less than one year’s experience in Medicines Registration. The course consists of 4.5 Days of lectures and practical work that needs to be done in class and at home (minimum 2 hours at night each night) and covers 3 enterprise standards that are detailed below. The delegate is expected to hand in 3 assignments, two knowledge assignments and a further practical assignment, after completing the lectures. In order to achieve the certificate, all assignments must be completed to the accepted standard.
Enterprise Standard 1. The compilation of an application for registration (ZA-CTD) of a generic medicine. ZA-CTD Modules 1, 2 & 3 are compiled and evaluated. The ZA-CTD applications compiled by the delegates are individually assessed (Performance assessment). A Knowledge assessment is completed.
Enterprise Standard 2. Evaluating a partially completed registration dossier according to the latest policy requirements /guidelines and is project based. It involves the review and evaluation of an application for registration of a generic medicine. Each delegate compiles a CTD dossier and three reports, which are individually assessed (Performance Assessment).
Enterprise Standard 3. Licensing, MCC inspections, Post Registration amendments, Third Party Contracts, Validation, SOP’s and Audits. The delegate’s understanding is assessed through participation in a role-play inspection (performance assessment) and a Knowledge assessment.