Tag Archives | RWE

RWE

RWE – What are the Opportunities across the product life cycle?

What are the real-world evidence tools and how can they support decision making? EMA-EuropaBio Info Day – 22nd November 2016 Dr Alison Cave, Principal Scientific Administrator, Pharmacovigilance and Epidemiology Department, EMA [View Slide Deck…] RWE – What are the Opportunities across the product life cycle? Medicines Development Population-based databases to characterize frequency and distribution of […]

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Germany – Impact of Amendment of the German Drug Act on NIS

The German Bundestag adopts Fourth Act on the Amendment of the German Drug Act and Other Provisions Author: Mark Heinemann, Princpal Regulatory Consultant, RWE and Insights, inVentiv Health The 4th law on the amendment of the German Drug Act came into force on December 24, 2016 (G. v. 20.12.2016 BGBl. I S. 3048 (Nr. 63)). […]

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Research Involving Human Beings in France – Impact on NIS

Author: Mark Heinemann, Princpal Regulatory Consultant, RWE and Insights, inVentiv Health An important modification of the French research law framework occurred in November 2016 with the coming into force of decree No. 2016-1537.  The law describes the modalities for research involving humans and eventually adds ‘non-interventional research’ to the research law framework. The most recent […]

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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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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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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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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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Webinar: Pragmatic Studies for Real World Evidence – Lifting the Veils

Regulators, Health Technology Assessment (HTA) agencies and health care payers are increasingly demanding Real World Evidence (RWE) to support both initial product approval/reimbursement as well as continuing approval/reimbursement over a product’s life cycle. Clinical trials are frequently conducted to demonstrate safety and efficacy, Non-Interventional Studies (NIS), patient and product registries to generate RWE, but increasingly […]

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What are Pragmatic Clinical Trials?

There has been a recent resurgence in the use of the term ‘pragmatic clinical trial’, but what are they? This free report (2015-11-22_Pragmatic-Clinical-Trials_CHCUK#1) summarises the current literature, proposed legislative changes (i.e., the EU Clinical Trials Regulation) and guidelines on pragmatic clinical trials (PCTs). Topics covered, include: What are Pragmatic Clinical Trials (PCTs)? What is the […]

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