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Thought Leadership

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Thought Leadership

iVigee experts are respected leaders within the world of Pharmacovigilance, IT and AI.

Our senior team comprises many individual thought leaders who contribute to and influence the direction of these areas globally.

Their expertise, experience, and participation in the development and future of the industry around the world is significant, and notable examples of this in different areas include:

International and Regulatory Committees, and Learned Societies

  • Advisory Board member at the International Society of Pharmacovigilance.
  • Advisory Board member at the SFDA.
  • Member of the EMA CHMP/Pharmacovigilance Working Party.
  • Chair of the Special Interest Group on the Pharmacovigilance Career Framework.
  • Leader of the ISoP Global Pharmacovigilance Professional Certification program.

Fellowships

  • Fellow of the International Society of Pharmacovigilance (FISoP).
  • Global Fellow of Medicines Development (GFMD).
Group of business people attending a pharmacovigilance conference

International Presentations

Our team has delivered hundreds of presentations on various pharmacovigilance topics at global conferences, including:

  • DIA Global, Europe, China, MENA, Japan, Latin America Annual Meetings.
  • ISoP Annual Meetings and Mid-year trainings worldwide.
  • Scientific organizers of the ISoP Seminar on Intelligent Automation in Pharmacovigilance (known as the Boston Seminar) since 2016.
  • APEC Pharmacovigilance Center of Excellence.
  • Korea Institute of Drug Safety.
  • EUPV Congress.
  • Oracle Health Sciences Safety Consortium Innovation Summit USA.
  • RQA courses and congresses.
  • DIA Global Pharmacovigilance and Risk Management Strategies.

Webinars and Trainings

Serving as DIA Faculty members, our experts have taught courses on:

  • Excellence in Pharmacovigilance for Clinical Trials and Post-authorization (uninterrupted teaching since 2006).
  • Practical Guide to Pharmacovigilance.
  • Signal Management.
  • Benefit-Risk Management.
  • Risk Management Plans.
  • Periodic Safety Update Reports (PSURs).
  • Pharmacovigilance System Master File (PSMF).
  • Artificial Intelligence in Pharmacovigilance.

Additionally, they are faculty members for university courses at King’s College London, Imperial College London, London School of Hygiene and Tropical Medicine, and the University of Hertfordshire.

Publications

Our team has co-authored international guidelines, including:

  • ICH E2F.
  • Volume 9A.
  • CIOMS IX.
  • EMA Guideline on safety and efficacy follow-up - risk management of advanced therapy medicinal products.

References

iVigee is proud to have many esteemed references that may be provided upon request.

Awards

Recognized for their outstanding contributions to pharmacovigilance, members of our team have received Excellence in Service awards from the DIA and been previously involved in companies who received the HM Queen’s Award for International Business.

Certificates

Our experts have obtained a wide range of advanced professional certifications from prestigious training courses and seminars focused on pharmacovigilance, risk management, and regulatory sciences.