Masterclass 101 - Introduction to Regulatory Affairs

Duration: approx. 1.5 hours + (average 5 self study hours) Location: online Additional Features: Personality Assessment, Homework, Assessment, Additional Guidance Resources, Certificate This introductory session spells everything out for you from a general and bigger perspective. It focuses in on the local (SAHPRA) and international (EMA, ICH, EDQM, WHO, etc.) guiding authorities by providing understanding on the four main components of regulatory affairs. Learn the basics of the product application process for and compiling a dossier. You will understand what, who, when where and why RA is what it is! Commonly used jargon and key ideas/ concepts needed to grasp the essence of RA are also described. You will also determine if it is for you as a SWOT analysis is also done with examples to help participants relate personally.