Antibody on a white background. Vector diagram of the basic unit of immunoglobulin.

New GVP Module – Biological Medicinal Products

Guideline on Good Pharmacovigilance Practices (GVP). Product- or Population-Specific Considerations II: Biological Medicinal Products The European Medicines Agency (EMA) has adopted a new chapter to its guidelines on good pharmacovigilance practices (EU-GVP), entitled “Product- or population-specific considerations II: Biological medicinal products“.  The new chapter provides guidance on how to better monitor and manage the safety […]

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EU Collaboration Strengthens Safety Monitoring of Medicines

European Commission publishes three-year report on implementation of pharmacovigilance legislation Closer collaboration between the European Medicines Agency (EMA), the European Commission and the EU Member States, enabled by the new European pharmacovigilance legislation, has enhanced the monitoring of the safety of human medicines throughout their life cycle, for the benefit of patients. This is highlighted […]

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GVP Module IX – Consultation Open

Draft guideline on good pharmacovigilance practices (GVP) – Module IX – Signal management (Rev. 1) Regulation (EC) No 726/2004, Directive 2001/83/EC and Commission Implementing Regulation (EU) No 520/2012 (hereinafter referred to as REG, DIR and IR, respectively) include provisions for signal management in the European Union (EU) [DIR Art 107h, REG Art 28a, IR Chapter […]

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Female medicine doctor filling in patient medical history list during ward round while patient communicating with doctor. Medical care or insurance concept. Physician ready to examine and help

Enhancing the Application of Real-World Evidence In Regulatory Decision-Making

Enhancing the Application of Real-World Evidence In Regulatory Decision-Making Washington Plaza Hotel • Washington, DC March 3 & 4, 2016   Event Details The last decade has seen important progress in the development of evidence from routine clinical practice, and there has been a growing interest in harnessing such real-world evidence (RWE) to fill in […]

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Surgery, Operation Equipment in Hospital.

Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices

FDA has issued a draft guidance to clarify how they evaluate real-world data to determine whether it may be sufficiently relevant and reliable to generate the types of real-world evidence that can be used in FDA regulatory decision-making for medical devices. Real-World Data (RWD) is data collected from sources outside of traditional clinical trials. These […]

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HIPAA document with magnifying glass

Another Reminder to Keep Electronic PHI Secure

Another Record HIPAA Settlement, Another Reminder to Keep Electronic PHI Secure 4 August 2016, the US Department of Health & Human Services’ Office for Civil Rights (OCR) announced that Advocate Health Care Network (Illinois’ largest healthcare system) will pay a record $5.5 million settlement for violating HIPAA. The violations include failure to properly assess risks […]

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ABPI – Real World Evidence Workshop Report Published

The ‘Real world evidence’ workshop was held on 17 September 2015 as part of the Academy’s FORUM programme. It brought together participants from across industry, regulatory, academia and policy to explore the acceptability of real world evidence in regulatory and Health Technology Assessment (HTA) decision-making, aspirations for the use of this evidence in a regulatory context, […]

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