Sabine Velders

Domain Expert Pharma - Regulatory Affairs Medicinal Products
Sabine Velders

It started with fascination for the wonders of nature. Then came interesting biology lessons at school followed by an enthralling study Bio-Farmaceutische Sciences and related jobs. Now taxonomy calls. Structured medicines data linking. Unlimited possibilities for information analysis result.

With more than 20 years of experience in human medicinal product regulatory affairs Sabine is enthusiastic to use her domain knowledge for Taxonic – OntoPharma IT projects.
Her experiences cover management of Dutch and European medicinal products regulatory affairs procedures both at the health authorities as in innovative and generic pharmaceutical industry.

She considers IT data linking a great challenge for improving quality and efficiency in the growing amount of required accessible medicinal product data based on high quality of underlying referential data.

With her eye for details, team spirit as well as her pragmatic user orientated focus Sabine is very much driven to strengthen Taxonic – OntoPharma projects results.

I am inspired by the following famous statement by Benjamin Franklin.
It reflects how I want to cooperate with people in a team:

“Tell me and I forget. Teach me and I remember. Involve me and I learn.”

Experience & Qualities

Knowledge and skills:

  • Regulatory Affairs management medicinal products in EMEA region
  • Medicinal products dossier applications
  • CMC, safety and product information variations
  • Database maintenance medicinal products
  • PSUR planning
  • EMA Linguistic review product information
  • Readability tests package leaflets
  • eCTD
  • NEES

Clients:

  • Astellas Pharma Europe
  • Apotex Europe
  • Apotex NL
  • Medicines Evaluation Board in The Netherlands (MEB)
  • AMR Pharm Holland