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#32: 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 Science Officer
    • UBC, United States

    Dr. Annette Stemhagen is an epidemiologist, with over 30 years of public health research experience, including 20 years in the biopharmaceutical industry. She provides strategic consulting in epidemiology, pharmacovigilance, and risk management, and works with UBC teams to develop and implement creative and innovative study design solutions. She has specific expertise in REMS. She has designed and directed implementation of risk intervention programs, risk management evaluation studies, Risk Evaluation and Mitigation Strategies (REMS), and risk minimization programs for EU Risk Management Plans for more than 120 products. She was appointed as the first Industry Representative to the FDA Drug Safety and Risk Management Advisory Committee.

  • 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.

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