Sigrid is an expert in clinical oncology with extensive regulatory experience working in the European Medicines Agency (EMA) system. Sigrid applies her knowledge to successfully support companies on the clinical aspects of drug development.
Key Areas Of Expertise
Profound regulatory expertise in the clinical oncology space, including:
- Oncology drug development, including clinical trial design and regulatory strategy
- Marketing authorisation applications (MAAs), including regulatory clinical and scientific requirements
- Scientific advice for oncology drugs
- Chemical substances, biologicals and ATMPs
- EU product information (SmPC) content issues
- Tissue agnostic/Histology-independent drug development
Health technology assessment (HTA):
- Reimbursement applications including relative effectiveness
- Health economic principles
Clinical area of expertise:
- Oncology
Before NDA
Before joining NDA, Sigrid Klaar spent 14 years at the Swedish Medical Products Agency (MPA) as clinical assessor of marketing authorisation applications for oncology drugs in the EU centralised procedure and providing scientific advice to industry.
For 9 years, Sigrid was also highly involved in the EMA Oncology Working Party that supports the CHMP for oncology issues, most recently as its vice chair. She led the work on important guidance documents to industry, including updates of the Anticancer guideline.
Sigrid has special expertise in the contents of the EU product information, and she initiated and was a key contributor to the Appendix 3 to the Anticancer guideline that outlines the rules for oncology products for SmPC section 4.8 on Adverse reactions.
In addition, Sigrid has 5 years’ experience in health technology assessment (HTA) as medical advisor to the Swedish Dental and Pharmaceutical Benefits Agency (TLV). This includes health economic appraisals based on cost-utility analysis, as well as EUnetHTA joint clinical assessment (JCA) of relative effectiveness. She also worked on the new EU HTA regulation and the planning of its implementation.
Sigrid has a background as a M.D. and PhD. from Uppsala University, and as clinical Specialist in Oncology from the Karolinska University Hospital of Sweden.
Her clinical and research focus was breast cancer.