The RWE Equation: Finding the Right Late-Stage Study Design

White Paper – The Real-World Evidence Equation: Finding the Right Late-Stage Study Design Florian Eichmann, PhD, Principal, Scientific Affairs & Real World Evidence, Late Stage, inVentiv Health Clinical Stuart McCully, PhD, Vice President, Regulatory Consulting, Late Stage, inVentiv Health Clinical Although real-world evidence (RWE) has become increasingly popular for its insight into the use and […]

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Is your App a medical device? It’s healthy to know: MHRA issues updated guidance

Updated guidance issued to help identify the health apps which are medical devices and make sure they comply with regulations and are acceptably safe. From counting steps to helping healthcare professionals prescribe treatment for burns injuries, healthcare apps and stand-alone software are a part of everyday life. You might not realise depending on an unregulated […]

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EU Commission releases draft Privacy Code of Conduct for mHealth apps

The European Commission has drafted a code of conduct on privacy for mobile health (mHealth) apps (the “Code”). The Code has been submitted to the Article 29 Data Protection Working Group for approval. The Code aims to provide a user friendly guide to compliance with European data protection legislation for mHealth app developers. Once the […]

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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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