Social Networks and Pharmacovigilance: What Will Change?

Why Should You Attend:

A key benefit of social media is that it can be mined to generate hypotheses related to drug efficacy and safety. These data may provide an early warning about potentially serious but rare adverse events (AEs). However, social media also presents technical and regulatory challenges as pharmaceutical companies are required to report to regulatory authorities all AEs of which they become aware that contain the 4 required elements for reporting.

However, the emergence of social media and its use by biopharmaceutical manufacturers and their stakeholders present promising new opportunities along with challenges for pharmacovigilance (PV) professionals and procedures and processes will probably need to be reviewed and updated

Learning Objectives:

• To examine the different types of social networks (Facebook, Twitter, etc.) and identify similarities and differences.
• To understand the shift in the benefit/risk ratio determination and data collection caused by the possible use of these new media.
• To understand the present and future approach to addressing the problem.
• To evaluate the possible impact on pharmacovigilance/signal detection procedures and the need for corrective actions.

Areas Covered in the Webinar:

• Social networks: Overview and examples
• The existing guidelines: A critical appraisal
• Social networks and the new approach to benefit/risk ratio
• Possible impact on procedures/processes
• The role of artificial intelligence
• Possible evolutions and outcomes

Who Will Benefit:

• PV Stakeholders
• General Managers
• Policy Makers
• Knowledge Management Specialists
• PV Executives
• Regulatory Affairs Executives
• QPPVs
• IT Professionals

Instructor Profile:

Since January 2016, Marco Anelli serves as the head of pharmacovigilance and medical affairs advisory services at Product Life Group, an international consultancy company. Previously, he has been R&D director at Keypharma, an Italy-based ProductLife Group company, and was responsible for the coordination of all clinical and preclinical aspects of projects run internally and on behalf of clients.

Drawing on a career in the pharmaceutical industry that spans 25 years, Mr. Anelli provides expert oversight on a wide range of R&D and medical affairs related activities. He has participated in and coordinated all stages of drug development -- from formulation to Phase I-IV and pharmacovigilance. In addition, he is a qualified QPPV and has prepared and overseen more than 200 non-clinical and clinical overviews and summaries.

In recent years, has worked extensively in the fields of pharmacoeconomics and health technology assessment. He has a medical degree from Milan University, specializations in medical statistics and clinical pharmacology from Pavia University and an international master’s degree in health economics and pharmacoeconomics from Pompeu Fabra University in Barcelona.

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