Dr Sif Ormarsdóttir former CHMP and SAWP member has joined the NDA Advisory Board. Dr Ormarsdóttir has a Ph.D. in medicine and is a specialist physician in gastroenterology, hepatology and internal medicine.
In 2001 Sif was employed by the Medical Products Agency in Sweden as a clinical assessor. In 2003, she moved to work for the Icelandic Medicines Agency and at the same time started her own private practice. Between 2004-2010 she was a member of the CHMP and the SAWP. As a member of the EWP, she was the coordinator for three regulatory guidelines in the field of gastroenterology and in 2010 she became the chair of the Gastroenterology Drafting Group at the EMA.
From 2011 to 2016 Sif worked for AstraZeneca as Associate Director Physician/Liver Safety Expert, where she was Chair and clinical lead of the Hepatotoxicity Safety Knowledge Group.
Dr Ormarsdóttir is joining the NDA Advisory Board, a unique team of experts comprising some of the most well-known names in the industry, many of whom have been involved in designing the regulatory and HTA systems in place today. Together, they provide strategic advice and unbiased second opinions to pharmaceutical clients during part of, or the complete end-to-end drug development life cycle. This also includes support and advice during interaction with regulatory agencies, be it at scientific advice, during review of a marketing authorisation application or at any stage post-authorisation.
Dr Werner Van den Eynde, Vice President NDA Advisory Board, commented on the appointment:
“The NDA Advisory Board is one of a kind – no other professional body comes as close to reflecting the current opinions and practices of the world’s regulatory and reimbursement agencies. I am very excited to welcome Dr Sif Ormarsdóttir on board. With her experience in and in-depth knowledge of gastroenterology, hepatology and diabetes as well as pharmacovigilance and liver safety she will be able to add tremendous value to clients in these areas and help them to make new and promising medicines available to patients.”