Marloes van der Geer

Marloes van der Geer works as senior regulatory affairs scientist at Qdossier. Marloes holds a master in Life Sciences (Drug Innovation) from the University of Utrecht, the Netherlands. For nine years she held several positions at Hoffmann-la Roche in Switzerland, including the role of regulatory intelligence manager and regulatory policy lead for the EMEA region. Marloes has been actively involved in several industry associations like EFPIA and IFPMA. Also, she contributed to the ongoing IMI PREFER project in Europe, focused on the generation and use of patient preference data. In 2019, Marloes joined Qdossier. Marloes’ areas of expertise are: eCTD, lean authoring, publishing, biopharmaceuticals (incl. biosimilars), clinical development, regulatory convergence & harmonization and facilitated registration pathways (incl. orphan drugs), local RA activities (e.g. product information management).

  • Next: 20 Jun 2022 Live online
  • Also: 26 Sep 2022 Live online

Regulatory Strategies for Orphan Drugs

Live online
Focused

This must-attend event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.

  • 6 CPD hours
  • Presented by Marloes van der Geer
  • Next: 27-28 Jun 2022 Live online
  • Also: 19-20 Sep 2022 Live online

The FDA Drug Approval Process

Live online
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 Marloes van der Geer
  • Next: 7-8 Jul 2022 Live online
  • Also: 13-14 Oct 2022 Live online

Variations to Marketing Authorisations

Live online
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 Marloes van der Geer
  • Next: 4-5 Jul 2022 Live online
  • Also: 11-12 Oct 2022 Live online

Biosimilars

Live online
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 Marloes van der Geer
  • Next: 11 Jul 2022 Live online
  • Also: 19 Oct 2022 Live online

Filing eCTD Submissions

Live online
Focused

This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for a successful submission.

  • 6 CPD hours
  • Presented by Marloes van der Geer
  • Next: 28-29 Nov 2022 Live online

Common Technical Document

Live online
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 Marloes van der Geer