#32: Preparation of Risk Evaluation and Mitigation Strategies Assessment Reports
Catherine Sigler, DVM, PhD, MPH
- Executive Director, Safety, Epidemiology, Registries, & Risk Management (SERRM)
- UBC, An Express Scripts Company, United States
Dr. Catherine Sigler is a Senior Epidemiologist and Executive Director in United BioSource Corporation (subsidiary of Express Scripts Inc.) department: Surveillance, Epidemiology, Registries and Risk Management (SERRM). She provides technical expertise in pharmaceutical safety issues as relate to epidemiologic approaches and REMS. Since January 2015, she has also led the Value Demonstration Team that is focused on generating the real world evidence needed to gain and maintain market access. She has broad therapeutic-area experience and direct expertise in risk management strategies including signal evaluation and the design, conduct, and analysis of case-control, cohort, registries, and large observational studies.
Annette Stemhagen, DrPH, FISPE
- Senior Vice President, Safety, Epidemiology, Registries & Risk Management
- UBC, United States
Dr. Stemhagen has more than 30 years of research experience, 20 yrs in safety surveillance. She has expertise in design, conduct, and analysis of peri-approval registries, LSS, actual use studies, including >35 regulatory-mandated safety studies. She has developed REMS for more than 80 products.
Mark A. Ammann, PharmD
- Catalyst Regulatory Services, LLC, United States
Mark A. Ammann is the owner and President of Catalyst Regulatory Services, LLC. Prior to founding Catalyst, Mark established and built a successful Regulatory Affairs consulting practice at United BioSource Corporation where he served as Vice President of Regulatory Affairs and provided strategic regulatory consulting to a range of clients from start-up pharmaceutical companies to large multinational corporations. He has over 25 years of experience in the pharmaceutical industry and held positions with increasing levels of responsibility within Regulatory Affairs at three major pharmaceutical companies (Novartis, Pharmacia and Pfizer). He received his Doctor of Pharmacy degree from University of Michigan.