Trends in Pharmacovigilance – Market Research and Future Impact

Life Sciences, Clinical Trials, Pharmaceutical Regulation, Pharmaceutical, Drug Safety,
  • Monday, May 14, 2018

This webinar will discuss an overview of key findings within recent pharmacovigilance market research conducted by Industry Standard Research. It will offer insight into the latest trends, best practices and challenges small, mid and large size pharmaceutical companies face with pharmacovigilance internal processes and effectiveness, outsourcing and more. Learn what drivers and key challenges play critical roles in patient safety, complying with all health agency regulations and minimizing company risk. Also explored will be actual case studies and examples of how leading pharmaceutical companies today are partnering with Bioclinica to overcome internal pharmacovigilance challenges and develop best practices.

Speakers

Angus McCulloch, Senior Vice President, Safety & Regulatory Solutions, Bioclinica

Angus McCulloch is an experienced leader in the Pharmacovigilance industry with 30 years of experience in the management and delivery of operational excellence results. He has driven numerous transformation programs in Drug Safety, Regulatory Affairs, Clinical Development, and R&D, and was also accountable for practice management and expansion of the Pharmacovigilance Operations and consulting practice.  In addition to operations programs, Angus has advised his clients in the selection, customization, and delivery of technology platforms to support their drug safety operations.  Prior to this role Angus held leadership roles at TCS, Cognizant, IBM and Accenture.  Angus holds bachelor’s degrees in Biology and Industrial Engineering from Purdue University.

Message Presenter

Andrew Schafer, President, Industry Standard Research

Mr. Schafer joined Industry Standard Research (ISR) in 2010 as President after spending eight years with Quintiles. As President of ISR, Mr. Schafer is responsible for directing syndicated research products, custom market research efforts, and strategic planning. While at Quintiles he was responsible for primary market research activities, leading strategy, functional service provider, and market development activities for data management and biostatistics, corporate new service introduction, and led the North American Corporate Strategy function. Prior to his work in the pharmaceutical industry, Mr. Schafer spent 10+ years in the telecommunications industry focusing on new product development and introduction. Mr. Schafer received undergraduate degrees in Finance and Economics and a MBA in Marketing and Statistics from Syracuse University.

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Who Should Attend?

    • Head, SVP, VP, Senior Director, Director, Associate Director, Manager, Associate Manager:
        • (Drug) Safety/Safety Operations or Pharmacovigilance
        • Pharmacovigilance Case Processing
        • Pharmacovigilance Reporting
        • Aggregate Reporting
        • Patient Safety
        • Medical Writing
        • Clinical Development and Product Safety
        • Global Direct Safety
        • Benefit & Risk
        • Drug Safety and Risk Management
        • Safety Leader
        • Medical Director of PV and Patient Safety
        • Medical Scientific Liaison
        • Drug Safety Operations
        • Strategic Planning
        • Signal Detection
  • QPPV (Qualified Person for Pharmacovigilance)
  • Head of Therapeutic areas

Xtalks Partner

Bioclinica

Bioclinica is a global life sciences solution provider that utilizes science and technology to bring clarity to clinical trials – helping companies to develop new life-improving therapies more efficiently and safely. Successful clinical trials require the ability to see key details and uncover hidden insights, and Bioclinica’s hundreds of experienced scientific, medical, and domain experts bring unmatched insight across the development lifecycle, from the initial protocol to post-approval. The company’s cloud-based offerings include medical imaging; cardiac safety; clinical adjudication; randomization and trial supply management and optimization; electronic and eSource data capture; site payments and forecasting; pharmacovigilance; trial management; and risk-based monitoring solutions. A true multifaceted partner to trial sponsors and Contract Research Organizations (CROs), Bioclinica offers an integrated App xChange partner ecosystem, a global network of research sites, patient recruitment services, and post-approval research expertise to provide committed, detail-focused service through all stages of drug development. The company’s thousands of employees serve more than 400 pharmaceutical, biotechnology and device organizations – including all of the top 20 biopharmaceutical companies and leading CROs – through a network of offices in the U.S., Europe, and Asia.

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