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#33: Preparation of Risk Evaluation and Mitigation Strategies Assessment Reports


Instructors

  • Catherine  Sigler, DVM, PhD, MPH

    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

    Annette Stemhagen, DrPH, FISPE

    • Senior Vice President and Chief Scientific Officer
    • UBC, United States

    Dr. Stemhagen is an epidemiologist with over 30 years of public health research experience, including 20 years in safety surveillance of pharmaceutical, biotechnology, and vaccine products. She is the SVP of Safety, Epidemiology, Registries and Risk Management and Chief Scientific Officer at UBC, where she provides strategic consultative services to Sponsors, particularly in the areas of REMS, observational studies and RWE. Dr. Stemhagen has specific expertise in safety surveillance and design, implementation, and analysis of epidemiologic studies, Risk Evaluation and Mitigation Strategies (REMS) registries, large streamlined safety studies, and actual use and observational studies for products in Phase IIIb and post approval.

  • Mark A. Ammann, PharmD

    Mark A. Ammann, PharmD

    • President
    • 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.