Enterprise Standard 5
This 3-day workshop is directed at Pharmacists who have some experience in Medicines Registration but have not had any experience in registration of Biological Medicines.
The objective of the course is to provide the knowledge and skills required for competence in completion of the ZA-CTD form for Application for Registration of a Biological Medicine in South Africa.
Requirements for entry
- Qualified Pharmacist employed in the Pharmaceutical Industry who has completed the Medicine Registration Basic or a Regulatory Pharmacist with 1 – 2 Years of Regulatory experience.
- Regulatory Scientist with a BSc. Degree: Must already be employed in the pharmaceutical industry and has completed the Medicine Registration Basic or have at least 1-2 years’ experience in the registration of medicines in the CTD format.
At the end of the course, participants will:
- Be familiar with the different types of biological medicines.
- Be familiar with the principles of biological medicine manufacture for each type of Biological Medicine.
- Know how to compile a medicine registration application for biological medicine according to the latest MCC guidelines.
Assessment for this Enterprise Standard is project based.