Date: February 8-9, 2024 (1.5 days)
Price: 10 350 SEK per participant
Course Language: English
Diploma: Certificate is awarded after completion of 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 includes 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 will be included.