Netherlands Discussion Group
The Netherlands Area Biotech (NLab) Discussion Group is the first CASSS discussion group located outside the US and is intended to enable the local area community of industry, academic, and regulatory professionals to meet and share ideas and experiences, thereby working together to resolve scientific challenges in the field of biopharmaceutical development and regulation.
The NLab discussion group goals include:
- Share learning across industry, academia, and health authorities in Europe in general, and in the Netherlands in particular.
- Generate new scientific and technical insights and solutions for developing biopharmaceutical products in the future.
- Contribute to the expansion of CASSS’ mission, vision, influence, and community in Europe.
Click on the sections below for detailed information:
Pharmacopoeia Approaches | 1 October 2025 | Virtual
The NLab Discussion Group is the first CASSS Discussion Group located outside the US and enables the local area community to meet and share ideas and experiences. Join Featured Speaker Michiel Paus, Organon Pharma BV, who will present "Chinese vs. Harmonized Pharmacopoeia Approaches: A Case Study on Dissolution Acceptance Criteria". Register by September 29.
Attendance and Substitution Policy
CASSS reserves the right to withdraw, replace, add, or substitute presenters, speakers, and other guests without notice. Entry into the conference is at the sole discretion of CASSS and CASSS reserves the right to refuse entry to anyone for any reason.
"Chinese vs. Harmonized Pharmacopoeia Approaches: A Case Study on Dissolution Acceptance Criteria"
Michiel Paus
Organon Pharma BV
This talk will discuss the nuanced differences between the acceptance criteria of the harmonized USP/EP/JP approach and the Chinese Pharmacopeia implementation. It will also provide a brief introduction to dissolution testing as a case study. Outcomes from statistical simulations will be shared, highlighting the impact of these differences and the associated risks from a manufacturing perspective. Attendees will gain valuable insights into the practical implications of these variations and learn from real-world regulatory experiences.
Michiel Paus
Organon Pharma BV
Michiel Paus leads the Center for Mathematical Sciences (CMS) team at Organon, a group of five expert statistical consultants that provides global decision support to Organon’s Manufacturing Division. Their work focuses on the non-clinical side of manufacturing for both small and large molecules, covering areas such as development, supply, and life-cycle management. With expertise in risk assessments, root-cause analyses, and regulatory filings, Paus and his team bring a deep understanding of the statistical and regulatory challenges faced in manufacturing. This positions him to provide key insights into dissolution testing criteria, statistical differences, and manufacturing risks covered in this talk.
Promote Your Participation
Here are some ways you can share your message:
- Follow CASSS on Facebook, X, and LinkedIn. Stay up-to-date on the latest Discussion Group announcements and opportunities. Links can be found in the right column or at the bottom of this page.
- Share your participation via your personal Facebook, X, and LinkedIn accounts. Whether you are a recurring presenter or this is your first time attending, we are grateful to have you join us this year.
- Share the news with your colleagues who run your organization's official social media channels. We are proud to show our community your participation - let your community convey their support too.
- Personalize your email signature. Add an image or short message to your default email signature to let your colleagues know you will be attending the Discussion Group.
- Remember to tag CASSS on all social media posts.
If you have any questions about this media kit, please reach out to Renee Olson.
Register Now
Save your spot for the virtual Netherlands Area Biotech (NLab) Discussion Group on 1 October 2025. Register by September 29, 2025.
