Enterprise Standard 4
A three – day Workshop (Max 4 delegates) is directed at Pharmacists who have some experience in Medicines Registration but have not had any experience in compiling a submission containing clinical and non-clinical data. This course focuses on Modules 4 & 5 of the ZA-CTD.
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.
The following topics are covered:
Understanding the terminology used in clinical trials. Review of clinical trial designs, Review of Clinical Trial Reports – Evaluating and summarising clinical trials. An introduction to the meaning of the statistical parameters used in clinical trials. Confidence intervals and Hypothesis testing an overview. Pharmacokinetics, Bioavailability, bioequivalence and the Biostudy. Animal Toxicology and Pharmacology.
Assessment for this Enterprise Standard is project based.