Olca joined NDA in 2018 and specialises in helping clients across a wide range of products in various developmental stages during interactions with the EU regulatory authorities. Her vast range of scientific as well as operational regulatory expertise allows her to successfully take on both a strategic and a more operational role depending on the client’s specific needs.
Key Areas Of Expertise
Successful development of Regulatory strategy for Phase I-IV drug development, focusing on the EU market and overseeing international and global filings
- Early and late-stage development of small molecules, biological, orphan and non-orphan medicinal products as well as ATMPs
- Regulatory roadmaps
- EMA and national Scientific Advice procedures
- Orphan application designations
- Paediatric development, PIP/waiver strategy and authoring
- Clinical trials
- MAAs submission to approval
- Life cycle management, new indications, variations
- Authoring regulatory MAA submission and core CTA documents
- Managing, preparing, and finalising quality regulatory documents, including gap analyses
- therapeutic experience in oncology, haematology, immunology, CNS and metabolic diseases
- Interaction with Regulatory Authorities
- Leading cross-functional submission teams
Olca held EU and International Regulatory Affairs positions at, CRO Clinipace Worldwide, CSL Behring, Novartis Pharma and in biotech Evolva SA, gaining 13-year experience across all stages of product development and life cycle management in, hematological and solid cancers, metabolic diseases and CNS therapeutic areas. Olca has a PhD degree in Biochemistry from the Federal Institute of Technology Zurich (ETH).
Novartis experience with 5 HTA’s and EMA joint scientific advice.
Jun 1, 2013, Novartis Company Internal publication. A critical assessment of the first joint HTA advice (pilot project) obtained for the market access / clinical development of 3 compounds
Yeast artificial chromosomes employed for random assembly of biosynthetic pathways and production of diverse compounds in Saccharomyces cerevisiae Aug 1, 2009 Microbial Cell Factories publication (Maiden name Titiz)
Dr Olca Huijsmans