Hans van Bruggen

Hans van Bruggen is CEO of and Senior Regulatory Affairs Scientist at Qdossier. He holds an MSc. in Pharmaceutical Medicine from the University of Surrey (UK) and has worked in the pharmaceutical industry for more than 35 years, primarily at global or European headquarters sites. He has gained a wealth of experience and a comprehensive view on what information is needed to evaluate the benefit/risk ratio of drugs for patients and healthy volunteers. He approaches interdisciplinary and international processes using that scientific background. He applies new technologies and Artificial Intelligence to facilitate the business and let people focus on what they can do best.

  • Next: 26-27 Jan 2023 Live online
  • Also: 12-13 Jul 2023 Classroom
  • Also: 30-31 Oct 2023 Live online

Biosimilars

Live online, Classroom
Focused

A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.

  • 12 CPD hours
  • Presented by Hans van Bruggen
  • Next: 2-3 Feb 2023 Live online
  • Also: 15-16 Jun 2023 Classroom

Variations to Marketing Authorisations

Live online, Classroom
Focused

A two-day event that will provide an invaluable overview of the EU system for variations, with practical advice on the preparation and submission of variation applications using the various European procedures.

  • 12 CPD hours
  • Presented by Hans van Bruggen
  • Next: 6-7 Feb 2023 Live online
  • Also: 14-15 Jun 2023 Classroom
  • Also: 2-3 Oct 2023 Live online

The FDA Drug Approval Process

Live online, Classroom
Focused

A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US

  • 12 CPD hours
  • Presented by Hans van Bruggen
  • Next: 13-14 Mar 2023 Live online
  • Also: 10-11 Jul 2023 Classroom
  • Also: 27-28 Nov 2023 Live online

The Common Technical Document

Live online, Classroom
Focused

A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.

  • 12 CPD hours
  • Presented by Hans van Bruggen