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Thought Leadership

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Thought Leadership

Acknowledged experts and world leaders .

Our senior team comprises many individual experts and thought leaders within the world of Pharmacovigilance, Medical Safety, IT and AI who contribute to, influence, and participate in the development and future direction of these areas globally.

Team has successful track record from leadership positions at Pfizer, BMS, Vertex, Sanofi, and senior ex-regulators from EMA, CHMP, PRAC, and representing EMA at ICH and CIOMS groups. Ex-member of EMA Innovation Taskforce finding the best new regulatory pathways for innovative products. 

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.
  • Co-Chair, Japan Pharmacovigilance Global Integration Project, Bristol-Myers Squibb
  • Co-Chair, Clinical Scientific Committee, a R&D committee of senior leaders which approves all clinical protocols, Bristol-Myers Squibb
  • Member, Senior Safety Forum, Global Pharmacovigilance and Epidemiology’s governance council, Bristol-Myers Squibb
  • Global Worldwide Safety Standards Committee, Pfizer Global Research and Development

Fellowships

  • Fellow, American College of Physicians (FACP)
  • Fellow, American College of Cardiology (FACC)
  • Fellow of the International Society of Pharmacovigilance (FISoP).
  • Global Fellow of Medicines Development (GFMD).
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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.

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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, many 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.

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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.

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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.

References

iVigee is grateful to have earned the trust of many esteemed clients, and we are happy to provide references upon request.

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Contact us about our technology and services.

Whatever your pharmacovigilance requirements, our world-leading technology platforms and globally experienced operational teams can provide the solution.

Email us at info@ivigee.com or fill in and submit the form below.

Our Business Development team will respond within one working day.



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