Learning Outcomes
The main objective of the course is to understand the procedures for licensing and operating industrial units, procedures for the design, development and control / quality assurance of pharmaceutical preparations based on the ΕΜΑ / FDA / ICH guidelines.
Course Content (Syllabus)
Pharmaceutical Industry, Good Manufacturing Practices (GMP)
Approval of the Pharmaceutical Industry operation
Marketing authorization for medicinal products.
Product Development and Quality Control Guidelines of Pharmaceutical Products
Trade Marks and Patents in the Pharmaceutical Industry
Pilot and Scale-Up Techniques
Production Management
Kinetic Principles and Product Stability Testing
Quality Control and Assurance