Heli Suila
Finnish Medicines Agency (FIMEA)
Dr Heli Suila joined the Finnish Medicines Agency (FIMEA) in 2015 as a quality assessor for biological medicinal products. Her main activities and responsibilities have included assessments of European Medicines Agency (EMA) centralized marketing authorization applications, scientific advices, as well as national clinical trial applications. She has a strong background in molecular cell and stem cell biology. At EMA, Dr Suila is the Finnish member of the Committee for Advanced Therapies (CAT).
Appearances
DateJune 10, 2021Session Chairs
Lyell Immunopharma, Inc.Orca BioFinnish Medicines Agency (FIMEA)Session Speakers
Medicines and Healthcare Products Regulatory Agency (MHRA)European Medicines Agency (EMA)Emergence and Advancement of Technologies: Regulatory Challenges and ConsiderationsSingapore HSACBER, FDA
DateOctober 19, 2021The EU Medical Device Regulation (MDR), which came into full effect in May 2021, has brought in new requirements for drug delivery devices often used for biologic products…Session Chairs
Speaker
Session Speakers
Notified Body No. 0318, based at the Spanish Medicines Agency (AEMPSUCB Farchim SABSI Group
