Author Archive

The Next Frontier in Ensuring the Quality of Medicines: Maintaining International Quality and Safety Standards in the Manufacturing and Supply of Active Pharmaceutical Ingredients

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Today Pugatch Consilium launches The Next Frontier in Ensuring the Quality of Medicines: Maintaining International Quality and Safety Standards in the Manufacturing and Supply of Active Pharmaceutical Ingredients. 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 drug regulators across the globe.

Pharmacovigilance is the name given to the mechanisms and tests that together map and ensure the safety of a medicine throughout its life span ...

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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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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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The Creative Industries and the BRICS – full report is now available on our site!

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A review of the state of the creative economy in Brazil, Russia, India, China and South Africa

This review examines the state of the creative economy in the biggest emerging economies in the world namely Brazil, Russia, India, China and South Africa – the BRICS. Although at different levels of development, these economies are in many ways undergoing similar transitions from economies based on manufacturing, industrial output and natural resources to economies in which economic activity is ...

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Dr David Torstensson speaks on clinical trials transparency at American Chamber of Commerce to the EU in Brussels

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Pugatch Consilium Partner, Dr Torstensson presented the main findings of the Pugatch Consilium report Heading in a Different Direction? The European Medicines Agency’s Policy on the Public Release of Clinical Trials Data at the report’s EU launch. The launch took place at the AmCham EU offices in Brussels, Belgium.

The report was commissioned by the US Chamber of Commerce’s GIPC. It examines the debate and policies in place on public disclosure of clinical trials data and information in Europe, the US, ...

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