Dr. Happ holds a PhD and brings to ReMedys 19 years of experience in regulatory affairs.
She has delivered successful applications for new biotech products, devices, and lifecycle management worldwide, including EU (via centralised procedure, mutual recognition and national procedures), Japan and USA.
She successfully negotiated with EMA and EU national agencies and participated in FDA, TGA and Health Canada meetings. Dr. Happ has a broad therapeutic development expertise metabolic endocrinology, reproductive health, dermatology, oncology and rheumatology. She is a recognized training expert on clinical development with focus on regulatory affairs topics and has been an invited speaker to several international conferences & training courses on Orphan Drugs. Dr. Happ is ReMedys key consultant on al regulatory matters.