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Clinical research / Pharmacology / Pharmaceutical industry / Drug safety / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use / Biotechnology / Regulatory requirement / Food and Drug Administration / Japan Pharmaceutical Manufacturers Association / Pharmaceutical sciences / Pharmaceuticals policy / Research


INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE Final Concept Paper S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals Dated a
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Document Date: 2012-06-22 05:08:19


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City

Washington DC / Brussels / /

Company

Safety Expert Working Group / /

Continent

Europe / /

Country

Japan / United States / /

IndustryTerm

Biotechnology product categories / pharmaceuticals / biotechnology science / biotechnology products / blood products / biotechnology safety / manufacturing process changes / /

MedicalCondition

diseases / disease / chronic therapy / /

Organization

FDA / European Union / Group Certain / ICH Steering Committee / Steering Committee / /

Person

R. Lee R. Bass / E. Maki R. Lee / /

Technology

tissue engineering / antibodies / Biotechnology / /

SocialTag