Regulatory Science Regulatory Science and Knowledge Sharing - 2022

We stay up to date and share our knowledge so we can serve our clients better.  Our regulatory science projects enable us to do so.

Check out the articles, abstracts and full publications of our Regulatory Intelligence:

• Drug Registration in Emerging Countries

  Judith P. ter Horst · Belinda Breedveld · Alex Zwiers

• ATMP challenges in the EU - lessons for future applications

  P. Maczuga · G. Corstens · Alex Zwiers

• Analysis of approval times of anticancer drugs between 2010-2017

  F. Scarpisi · Alex Zwiers

• Geriatric Regulation; can we do without?

  E. Charitou · L. Vromans · Alex Zwiers

• Old medicines, new indications

  M. Garsen · K. Ruijtenbeek · Alex Zwiers

• Orphan drug designation in the EU and the US – a critical review

  Ditte Lundvig · Belinda Breedveld · Alex Zwiers

• Post-Authorisation Studies

  V.K. Gonzales · D. Eikelboom · Alex Zwiers

• Preclinical requirements for anticancer Drugs in the EU

  F. Scarpisi · Alex Zwiers

• A Decade of Marketing Authorization Applications of Anticancer Drugs in the European Union

  Marjolein Garsen · Maaike Steenhof · Alex Zwiers

• Implementation of Quality by Design Principles in Regulatory Dossiers of Medicinal Products in the European Union (EU) Between 2014 and 2019
  

  Judith P. ter Horst · Sada L. Turimella · Frans Metsers · Alex Zwiers