'Medicinal product' presentation slideshows

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Clinical trial training course: Botanical new drug development form Clinical points of view

Clinical trial training course: Botanical new drug development form Clinical points of view. Tien-Tzu Tai MD. Center for Drug Evaluation, Taiwan. DISCLAIMER. 2. 2.

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GGR / RCM database 2007

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Francis P. Crawley Good Clinical Practice Alliance - Europe &

The Future of GCP and EU Regulations Annual Conference of the Bulgarian Association for Clinical Research Sophia, Bulgaria 14 December 2007. Francis P. Crawley Good Clinical Practice Alliance - Europe & Chairman, GCP Drafting Group World Health Organization fpc@gcpalliance.org. 1.

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Istanbul April 2011

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Dr. Pasqualino Rossi CHMP member

I farmaci generici nelle prospettive europee VI CONFERENZA NAZIONALE SULLA FARMACEUTICA CATANIA, 16/11/2206. Dr. Pasqualino Rossi CHMP member. - flash - Around Europe. SWEDEN

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EU Directive 2001/83/EC

EU Directive 2001/83/EC. Dr. P. V. Appaji , M.Pharm , Ph.D Director General, PHARMACEUTICALS EXPORT PROMOTION COUNCIL OF INDIA Hyderabad Email: dg@pharmexcil.com. Presentation by. CONTENTS. Which are EU Countries? Objectives of EU Directive 2001/83/EC

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The Practice of Granting SUPPLEMENTARY PROTECTION CERTIFICATES

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Medicines Policy and equity in health How can generic drug producers contribute?

Medicines Policy and equity in health How can generic drug producers contribute?. Christian Wieser GENAS Slovak Generic Association. E U legislation.

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Generic substitution and licensing

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POST APPROVAL CHANGE MANAGEMENT PROTOCOLS IN THE EUROPEAN UNION

POST APPROVAL CHANGE MANAGEMENT PROTOCOLS IN THE EUROPEAN UNION. (EC) No 1234/2008 1 October 2012 CHMP / CVMP Quality Working Party /EMA. Summary. 1. Post approval change management protocol (PACMP) 2. Concepts 3. Variation categories in the EU

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Introduction to the D T JV T aipei Symposium

Introduction to the D T JV T aipei Symposium. Dr. Wilhelm Volk 1 A Pharma International. Introduction to the D T JV T aipei Symposium. facts & trends affecting the pharmaceutical world definition of Generic pharmaceutical product different areas of the law are applicable/important

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Advanced Therapy Medicinal Products - ATMPs -

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Weesziekten en weesgeneesmiddelen

Weesziekten en weesgeneesmiddelen. Weesziekte of zeldzame ziekte : Prevalentie < 1/2000 Bv : mucoviscidose 1/5000, hemofilie 1 /10.000 Maar: ziekte van Crohn 6/2000, ijzerstapelingsziekte ( hemochromatose ) 1/200

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Q3. Will the cells be Genetically Modified?

Interim UK Regulatory Route Map for Stem Cell Research & Manufacture Version: 24.06.09. Start Here. Key:. Q1. Are the stem cells intended for Human Application? Discuss with HTA. Post-marketing Surveillance of Stem Cell ATMP. Positive Opinion of EMEA: Marketing Authorisation Granted.

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