Previous projects

Previous Human Health projects:

• External expert (Rapporteur) to the European Commission for the assessment of chemical mixtures toxicity

• External expert to the European Commission on the Threshold of Toxicological Concern (TTC)

• External expert (Rapporteur) to the European Commission on PFOS

• External expert (Rapporteur) to the European Commission on the Technical Guidance Document for risk assessment

• Peer review of more than 30 submissions for the OECD High-Production Volume Chemicals Programme

• Toxicology and preclinical assessments for more than 500 substances

• Safety evaluations of more than 150 cosmetics, including oral care products

• Monitoring of more than 500 toxicological studies

• Drawing up a risk-assessment methodology for ingredients of household products

Previous Regulatory Affairs projects:

• Developing a worldwide regulatory strategy. We have done this for several compounds

• Arranging and participating in a briefing meeting with the Innovation Task Force of the European Medicines Agency (EMA)

• Scientific and Regulatory Advice meetings with Health Authorities. We have extensive experience with the European Medicines Agency, but have also arranged and participated in meetings with other Health Authorities, such as the FDA (Pre-IND meetings, end-of-Phase II meetings, Advisory Committee Meetings), BfArM and PEI (Germany), the MHRA (UK), the Danish Medicines Agency (Denmark), Fimea (Finland), the MPA (Sweden) and CBG-MEB (The Netherlands)

• Applications for clinical trial approval in Switzerland and several countries within the European Union

• Applications to obtain designation as an Orphan Medicinal Product from the European Medicines Agency

• Applications for Paediatric Investigation Plans at the European Medicines Agency

• Successfully obtained access to the priority medicines (PRIME) scheme of the European Medicines Agency and obtained breakthrough designation from the EMA

• Marketing Authorisation Applications in the European Union. We have coordinated the procedures for 15 Centrally Authorised medicinal products. In addition, we have some experience with the Mutual Recognition Procedure

• Type I and Type II Variations. We have handled over 20 Variation Procedures

• Preparation and review of Product Information (SmPC, Package Leaflet and Labelling). A major contribution to guidance documents in this area has been made as a member of the Quality Review of Documents and Product Information Quality groups at the European Medicines Agency