By attending this training course between 1-3 April 2025 (in-person in London, UK or online), you will:

  • Develop a systematic understanding of the strategies for approval of established active substances in the context of abridged applications and OTC products
  • Gain critical insights into the regulatory requirements, directives, and documentation for established active substances
  • Learn to evaluate and communicate complex issues effectively, even in the absence of complete data
  • Build a network that will support you for the rest of your career
  • Earn 19 CPD hours

With an engaging programme led by Orlaith Ryan, Chief Technical Officer and co-Founder at Shorla Oncology (Ireland), and Eva Kopecna, Global Head of Regulatory Affairs, Medical and Pharmacovigilance at ACINO (Switzerland), this course is the ideal next step for regulatory affairs professionals looking to enhance their expertise.

This course is part of our range of Masterclasses and is Module 7 in our MSc programme. Our Masterclasses are developed and delivered by a faculty of expert speakers and validated by the University of Hertfordshire.

Discounted rates are available for TOPRA MSc students, those working for regulatory or government agencies, academic institutions, charities, patient groups, or in full-time education.