The Evolution of Pharmacovigilance: Labeling, Packaging and Pharmacopeia Standards

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Today Pugatch Consilium launches The Evolution of Pharmacovigilance: Labeling, Packaging and Pharmacopeia Standards. Authored by Professor Meir Pugatch, Dr David Torstensson and Ma’ayan Laufer this report provides a deep-dive analysis of the next generation of challenges facing pharmacoviglance regulators.

Pharmacovigilance is the name given to the mechanisms and tests that together map and ensure the safety of a medicine throughout its life span – from test tube to patient. As patients and healthcare professionals around the world access and use more ...

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Clinical Data and Disclosure Policies

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Pugatch Consilium, in partnership with the US Chamber’s Global Intellectual Property Center, releases Clinical Data and Disclosure Policies: The European Union, Member States, and International Best Practices. This report provides an exhaustive analysis of the clinical data transparency aspects of EU Parliament Regulation 536/2014 on clinical trials and EMA’s finalized policies on Publication and Access to Clinical Trials Data, as well as a review of the wider policy implications and interface of these policies vis-á-vis current data disclosure policies at ...

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How to Stay One Step Ahead of an Outbreak

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Pugatch Consilium’s Prof. Meir Pugatch and Rachel Chu publish an article in fDi Magazine (http://www.fdiintelligence.com/) on how building an innovation culture can help countries prepare for the outbreak of diseases such as Ebola. The article is part of Pugatch Consilium’s ongoing analysis and intelligence database on biopharmaceutical investment and innovation policy.

How to stay one step ahead of an outbreak  – Read more on our Research & Analysis Reports Page

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The US Chamber and Pugatch Consilium launch the third edition of the GIPC IP Index

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This week Pugatch Consilium, in partnership with the US Chamber’s Global Intellectual Property Center, released the third edition of the annual GIPC International IP Index. The 2015 edition of the Index, entitled UP: Unlimited Potential, maps the intellectual property environment in 30 economies. Overall, although challenges remain across the board, positive steps are being taken in many of the economies included in the Index. In fact, 20 of the economies mapped in 2014 improved their scores in the 2015 edition. The ...

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New article in IP Today – Staying Ahead: How Can Robust IP Protection Help Countries Prepare for the Next Ebola?

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This week IP Today published an article by Pugatch Consilium Partner, Rachel Chu.

Looking at the race to develop the Ebola vaccine as well as other new medicines, the article draws a connection between investment in R&D, clinical trials and the protection of IPRs – all aimed at developing next generation healthcare technologies and medicines.

“Although increasing resources directed towards the health system is among the most obvious steps policymakers can take, one element often overlooked is the level of support toward ...

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Developing a Culture of Pharmacovigilance

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Today Pugatch Consilium launches Developing a Culture of Pharmacovigilance. Authored by Professor Meir Pugatch, Dr David Torstensson and Ma’ayan Laufer this report examines one of the most important facets of a high quality drug regulatory structure, namely that of pharmacovigilance.

Pharmacovigilance is the name given to the mechanisms and tests that together map and ensure the safety of a medicine throughout its life span – from test tube to patient. As patients and healthcare professionals around the world access and ...

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Understanding the drivers of biopharmaceutical clinical research: Why do some countries get all the investment?

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Today Pugatch Consilium releases Scaling Up Global Clinical Trial Activity: Key Trends and Policy Lessons. This study uses regression analysis of data on 50 countries to provide a roadmap for creating a policy environment that is conducive to clinical trials. The study also benchmarks performance in the level of scope of clinical trial activity.
The main messages of the report are:

  • The creation of a pro-innovation culture is just as, if not more, important as improvements to health system capacity for ...
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