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Pharmacology / Clinical research / Biosimilar / Drugs / European Medicines Agency / European Directorate for the Quality of Medicines / Good manufacturing practice / Food and Drug Administration / Quality by Design / Pharmaceutical sciences / Pharmaceuticals policy / Pharmaceutical industry


EUROPEAN GENERIC MEDICINES ASSOCIATION (EU) & GENERIC PHARMACEUTICAL ASSOCIATION (USA) JOINT EGA & GPHA RESPONSE TO THE EU-US HIGH LEVEL WORKING GROUP
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Document Date: 2013-07-17 03:28:44

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File Size: 182,19 KB

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Company

Different Regulatory IP Systems / US High Level Working Group / Level Working Group / Extension Market Share (volume) Advanced Manufacturing / High-Level Working Group / /

Continent

Europe / /

Country

United States / Australia / South Korea / India / /

Currency

USD / EUR / /

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Event

FDA Phase / /

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IndustryTerm

generic medicinal products / manufacturing provision / biosimilar medicinal products / respective healthcare systems / pharmaceuticals / manufacturing sector / manufacturing base / software applications / data/ market exclusivity systems / reference product / pharmaceutical market / manufacturing sites / manufacturing practice inspections / reference products / manufacturing / release products / active pharmaceutical ingredients / generic and hybrid applications / pharmaceutical supply chain operators / generic products / medicinal products / /

Organization

European Medicines Agency / GENERIC PHARMACEUTICAL ASSOCIATION / US Food and Drug Administration / Therapeutic Goods Administration / GENERIC MEDICINES ASSOCIATION / EUROPEAN GENERIC MEDICINES ASSOCIATION / European Union / Pharmaceutical Association / /

Person

Gareth Macdonald / /

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Position

Pharma Technologist / Corporate Responsibility Coordinator / pilot international collaboration programme / /

Product

biosimilars / /

ProgrammingLanguage

DC / /

Technology

biopharmaceuticals / API / /

URL

http /

SocialTag