Christine Hirt is Management Consultant and responsible for regulatory business consulting at MAIN5. She has more than 20 years of experience in the field of Regulatory Affairs and worked for serveral pharmaceutical companies, most recently 8 years as Head of Regulatory Affairs (where she implemented an eCTD system) then at a Sofware vendor as Director Regulatory Competence Center before she joined the consulting company MAIN5. Christine is an internationally recognized expert for regulatory business and eCTD/XEVMPD/IDMP guidelines and regulations as well as an active member in several associations, such as DIN/ISO TC/WG6, IRISS, BPI and MEGRA. She consulted industry as well as agencies on their way to eCTD and IDMP.
Participa ativamente das atividades do IDMP Adoption Expert Group do WG6/TC215/ISO que contribui estimulando a adoção global do IDMP. Participa em outros grupos de especialistas e fóruns de debate sobre a implementação global do IDMP.