- Regulatory, preclinical and clinical Roadmap
- Scientific Advice and Follow-ups with AEMPS
- Preparation of IBs and IMPDs
- Design of regulatory toxicology studies
- Revision of Phase I clinical results
- Regulatory Support during development
- Phase I clinical trial on going
- All planned patients have been vaccinated
- Interim Safety data report will be available in the next weeks.
- Sonja van Meirvenne, CMC expert/ eTheRNA NV
- Joel Montane, regulatory Affairs Officer/ Asphalion S.L.
- Koen Huygens, QP/ eTheRNA NV
- Marta Rayo Lunar, Scientific & Regulatory Affairs Manager/ Asphalion
- Rob Gruters, Sponsor of the Phase II trial/ EMC