Compensation for Research Injuries: National Regulations and International Standards

Jun 27, 2013

Research regulations worldwide aim to prevent research injuries, as well as to provide remedies for injuries suffered by research participants, regardless of what or who may have caused those injuries. The ICH-GCP guidelines mandate that sponsors make provisions for compensation for research-related injuries, but largely leave compliance to applicable national or local regulatory requirements. Chitra Lele and Suhasini Sharma at Sciformix discuss the hotly- debated topic of how and why patients are to be compensated, and how worldwide regulations differ considerably. [prettyfilelink src=”http://ipimediaworld.com/wp-content/uploads/2013/06/5-Compensation-for-Research-Injuries.pdf” type=”pdf”]Compensation for Research Injuries[/prettyfilelink] ...

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What the Unitary Patent Means for the Pharmaceutical Industry

Jun 27, 2013

After nearly four decades in the pipeline, the countries of the European Union have finally signed an agreement that is expected to lead to a system of Unitary Patents. They will have pan-European effect and an associated Unified Patent Court to enable enforcement of the Unitary Patent across Europe. If the agreement is ratified by European member states, this will represent the most radical change to the patent landscape in Europe of the past 40 years. Martin MacLean at Mathys & Squire LLP examines the issues surrounding its implementation, and how it will affect the pharmaceuticals industry. [prettyfilelink src=”http://ipimediaworld.com/wp-content/uploads/2013/06/4-What-the-unitary-patent-means-for-the-pharmaceutical-industry.pdf” type=”pdf”]What ...

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Cancer: The Major Medical Challenge in Europe Today (Cancer Cures Made in Austria)

Jun 27, 2013

Austria is at the forefront in the fight against cancer in Europe, and plays a leading part in the worldwide campaign, with several pioneering initiatives. Be it innovative immunotherapy, novel molecular targets or radiation therapy, researchers and oncologists throughout Austria are working to develop and commercialise diagnostics and treatments. Sonja Polan at Life Science Austria explains how at the core of Austrian cancer research, multidisciplinary research networks are bringing industry, healthcare and primary research together. [prettyfilelink src=”http://ipimediaworld.com/wp-content/uploads/2013/06/3-Cancer-The-major-medical-challenge-in-europe-today.pdf” type=”pdf”]Cancer The major medical challenge in europe today[/prettyfilelink] ...

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Grabbing Hold of the Bar of Success in Drug Development

Jun 27, 2013

Globalisation and other recent developments such as stricter quality control criteria, evolving technologies, and the increasing stringency of regulatory standards, have imposed enormous pressures on biotechnology drug manufacturers. With such difficult basic conditions, only a limited few compounds will ever make it to Phase III, and even fewer will make it through to approval and to commercial manufacturing. Paul Nelles, at Vetter Pharma-Fertigung GmbH & Co. KG, explores whether a contract development and manufacturing organisation (CDMO) can help lower this bar? Or perhaps help to lift you higher, thus helping to improve a company’s odds of achieving success? [prettyfilelink src=”http://ipimediaworld.com/wp-content/uploads/2013/06/1-Grabbing-Hold-of-the-Bar-of-Success-in-Drug-Development.pdf” ...

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