Date: November 2-3 (1.5 days)
Price: 10 350 SEK per participant
Place: Physically at Hälsingegatan 40 in Stockholm (limitation of 12 participants) or Digitally
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.
The lecturer for the RA and GDP course is Ingela Frick. She is a strategic and business driven senior leader with experience from big global- as well as small Swedish companies. She is used to leading companies through changes, acquisitions and mergers and has strengths within regulatory, quality and pharmacovigilance, and late phase development together with launch preparations of pharmaceuticals.