Cognitive Computing in Pharmacovigilance: Revamping Drug Safety Using an Advanced Computing System

The cost of conducting pharmacovigilance is increasing year-on-year with the growing volume of cases received by the pharmaceutical companies. Among the major functions of a pharmacovigilance department, case management is considered to be the most resource-intensive process. Cognitive computing algorithms could automate several activities in pharmacovigilance, decreasing the overall costs of conducting pharmacovigilance. This white paper explores the use of …

Re-Imagining Drug Safety Powered by Genomics, Information Integration and Emerging Technologies

|| Whitepaper by Tata Consultancy Services. Pub. 17/08/2017 Abstract Scientific advancements, emerging technologies, and extensive information have created new opportunities for modernizing drug safety.  Simultaneously, the pharmacovigilance regulatory landscape is shifting to ensure improved safety for patients. This is the time to reimagine the  drug safety sector to transform it into an advanced, proactive and patient-centric practice. Introduction The global …

Pharmacovigilance Compliance strategies

At the World Drug Safety Congress Europe 2014 event, Noha Kassem, Senior Director, Quality and Head of the European Regional Centre, gave a presentation on “Pharmacovigilance Compliance strategies.” Download and learn: Pharmacovigilance Quality System Quality System Objectives Compliance in Pharmacovigilance Role of Quality Scope of Monitoring and Oversight Internal Audits Tiers of Oversight Download Presentation Found this interesting? You might …

Changing face of benefit risk management

At the World Drug Safety Congress Europe 2014 event, Lesly Wise, Takeda development Centre Europe, gave the presentation “Changing faceof Benefit Risk Management.” Download and learn: A brief History of Risk Management The impact of the 2012 legislation on risk management What do we need from a BR process Download Presentation Found this interesting? You might also be interested in …

Risk Minimisation: Tools and Evaluation of Effectiveness.

At the World Drug Safety Congress Europe 2014 event, Michael Forstner, Head PV Europe, Boehringer Ingelheim, gave the presentation “Risk Minimisation: Tools and Evaluation of Effectiveness.” Download and learn: What is happening? What does this mean? Nature of errors made in case and literature review which may be due to lack of vigilance Can’t we just hire more people and …

Social media and mobile reporting: Impact on PV operations.

Last year at the World Drug Safety Congress Europe, Dr David Lewis, Global head of pharmacovigilance, Novartis, gave the presentation “Social media and mobile reporting: Impact on PV operations.” Download and learn: Social Media landscape and pharmaceutical medicines Regulations guidelines for PV of digital media Mobile reporting applications for pharmacovigilance Social media as a source of ICSR s & potential …

Safety, pharmacoepidemiology and research in practice: assessment of causation

At last years World Drug Safety Congress Europe 2014 event, Anca Miclea, Senior Specialist Medical Safety and Epidemiology Global Pharmacovigilance, Abbott laboratories, gave the presentation “Safety, pharmacoepidemiology and research in practise: assessment of causation.” Download and learn: Safety and pharmacoepidemiology in the current practises Causation in pharmacoepidemiology Causation and signal assessment: credibility of research findings Take home message Download Presentation …

A-Z of HPAPI eBook, in support of the World HPAPI Congress 2015

Download eBook: A-Z of High Potency APIs

High potency APIs, highly potent compounds, HAPI, HPAPI – there are many ways to communicate the hazard, but the confusion surrounding the mitigation of the risks remains abundant. During our research, as we put together this year’s High Potency API World Congress, it became clear, that for this fairly new sector within the pharmaceutical industry, there were indeed challenges surrounding …

EU PV, Legislation, GVP, changes, Drug Safety

EU PV Legislation & GVP Modules: Challenges

At the 2014 World Drug Safety Congress Americas, Dr Janet Hormbrey, Merck Sharp and Dohme, gave a presentation on “EU PV Legislation & GVP Modules: Challenges”. Download and learn: GVP Implementation Upcoming Modules Implementation Challenges Module V – Risk Management Plans Module VII – Periodic Safety Update Report Module VIII – Post Authorisation Safety Studies Module IX – Signal Management …