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EU IP HD Webinar – Freedom to Operate

Published by European Commission (EC)

CoursesTrainingWebinars

It is a common practice for the company to conduct a Freedom to Operate (FTO) search to determine and reduce the risks of potential patent infringement prior to launching a new product or service. The FTO search is performed to find relevant third parties’ patents that may cover the new product or service. The FTO is also called “Patent Clearance”. If the company completely neglects the FTO search, and then, later on, the product is found to infringe a third parties’ patent, it is most likely that the company would be sued by the patentee as an infringement of the patent.

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European Medicines Agency. Qualification of Novel Methodologies for Drug Development: Guidance to Applicants (EMA/CHMP/SAWP/72894/2008). 2014.

Published by European Medicines Agency (EMA)

Drug DevelopmentEMAGuidelinePharmaceuticals 

This guidance is for qualification process addresses innovative drug development methods and tools. It will focus on the use of novel methodologies developed by consortia, networks, public/private partnerships, learned societies and pharmaceutical industry for a specific intended use in pharmaceuticals R&D. 

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European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). ICH S5 (R3) Guideline on Reproductive Toxicology: Detection of Toxicity to Reproduction for Human Pharmaceuticals. Step 5. 17 February 2020. EMA/CHMP/ICH/544278/1998

Published by European Medicines Agency (EMA)

Animal ModelsClinical TrialsEMAGuidelinePharmaceuticals ToxicityVaccine

This guideline applies to all pharmaceuticals, including biopharmaceuticals, vaccines (and their novel constitutive ingredients) for infectious diseases, and novel excipients that are part of the final pharmaceutical product. 

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