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).
Common Technical Document
1-2 Feb 2022
A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.
Regulatory Strategies for Orphan Drugs
16 Mar 2022
This must-attend new event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.
The FDA Drug Approval Process
21-22 Mar 2022
A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US
Biosimilars
4-5 Apr 2022
A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.
Filing eCTD Submissions
25 Apr 2022
This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for a successful submission.
Variations to Marketing Authorisations
26-27 Apr 2022
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.
Common Technical Document
5-6 May 2022
A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.
The FDA Drug Approval Process
20-21 Jun 2022
A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US
Regulatory Strategies for Orphan Drugs
27 Jun 2022
This must-attend new event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.
Biosimilars
4-5 Jul 2022
A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.
Filing eCTD Submissions
11 Jul 2022
This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for a successful submission.
The FDA Drug Approval Process
19-20 Sep 2022
A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US
Regulatory Strategies for Orphan Drugs
26 Sep 2022
This must-attend new event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.
Biosimilars
11-12 Oct 2022
A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.
Variations to Marketing Authorisations
13-14 Oct 2022
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.
Filing eCTD Submissions
19 Oct 2022
This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for a successful submission.
Common Technical Document
28-29 Nov 2022
A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.