Regulatory Affairs (RA) and
Good Distribution Practice (GDP)
Date: May 22-23, 2025 (1.5 days)
Price: 10 350 SEK per participant
Place: Digitally
Course language: English
Diploma: Certificate is awarded after completion of the course
About the course
Comprehensive training on relevant regulations and guidelines to fully understand the requirements in submitting new MAs for Human Medicinal Products in Europe. In addition to this - how to optimize the life cycle management through submitting relevant variations and line extensions. The course also included how to maintain the safety in pre- and post-approval phases, as well as understanding the complexity of working in a matrix organization. Comprehensive training on all chapters in the EU-GDP legislation and the practical applications of those, leading to understanding how to gain and maintain a Wholesaler license.
Please fill out this form and submit if you would like to register for this course