Medication Errors: Will the New Requirements Impact Your Processes?

Why Should You Attend:

In the European Union (EU), national competent authorities and EMA play a key role in identifying and reducing the risk of medication errors before and after the authorization of a medicine. For all medicines the presentation, labelling and leaflet are designed to prevent medication errors. However, in some cases, additional measures are needed to ensure that the medicine is used correctly, for example by introducing educational programs for healthcare professionals and patients. EMA will now systematically communicate on any additional measure decided upon at EU level to prevent medication errors. The new webpage will offer a reference point to patients and healthcare professionals for key advice on how to prevent medication errors in order to ensure the safe use of medicines.

This webinar will assist attendees in understanding the shift caused by the new requirements and in evaluating the possible impact on pharmacovigilance/signal detection procedures and the need for corrective actions.

Learning Objectives:

• To understand the shift caused by the new requirements
• To evaluate the possible impact on pharmacovigilance/signal detection procedures and the need for corrective actions

Areas Covered in the Webinar:

• Medication errors: definitions and examples
• The new approach to benefit/risk ratio
• The new reporting requirements
• Possible impact on procedures/processes

Who Will Benefit:

• QPPVs
• Safety managers and officers
• Regulatory affairs executives/managers

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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