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Documents Gene Therapy / Cell Therapy / Stem Cells – Regulations for the "New Biologics"

1. Gene Therapy / Cell Therapy / Stem Cells – Regulations for the "New Biologics" William R. Tolbert, Ph.D. AOAC-SCS Regulatory & Compliance Conference…

Documents Cell Therapy Manufacturing: Regulations and Facilities

1. Cell Therapy Manufacturing:Regulations and Facilities William R. Tolbert, Ph.D. BIOCOM Meeting – August 11, 2005 2. Roadblocks to Commercial Cell Based Products Regulatory…

Documents Genetic engineering and Gene therapy Right or wrong? Genetic engineering is one of the fastest...

Slide 1Genetic engineering and Gene therapy Right or wrong? Genetic engineering is one of the fastest growing medical sciences. There are 2 types of cell and so 2 types of…

Documents La nouvelle réglementation des médicaments de thérapie innovante Nicolas FERRY ANSM.

Page 1 La nouvelle réglementation des médicaments de thérapie innovante Nicolas FERRY ANSM Page 2 Procédure de mise sur le marché selon la DIR 2001/83/EC EMA Commission…

Documents Informa Atmp Gert Bos Nov 2009 Final

1. Regulatory challenges for combination-ATMP products Gert Bos BSI HealthcareDrug device Combination ProductsInforma, Prague, CZ17 November 2009 2. This presentation …

Documents Guidelines for the Inspection of Tissue and Cell Procurement and Tissue Establishments

INSPECTION OF TISSUE AND CELL PROCUREMENT AND TISSUE ESTABLISHMENTS Guidelines for Competent Authorities Edition II May 2008 European Union Standards and Training in the…

Health & Medicine Gene therapy

Slide 1 Dr. IFTHAQAR. H. F Definiton: An experimental technique for correcting defective genes that are responsible for diseases by replacing them. Several approaches to…

Documents Biomedical Engineering & Ethics Theresa Kennedy BME 181 Section March 4, 2013.

Slide 1 Biomedical Engineering & Ethics Theresa Kennedy BME 181 Section March 4, 2013 Slide 2 What are Ethics? The rules of conduct recognized in respect to a particular…

Documents Cancer Gene therapy Gene therapy Gene therapy involves the direct genetic modification of cells of.....

Slide 1 Slide 2 Cancer Gene therapy Slide 3 Gene therapy Gene therapy involves the direct genetic modification of cells of the patient in order to achieve a therapeutic goal.…

Documents CELL BASED THERAPIES LEGAL & REGULATORY Presentatienaam datum Presentator .

Slide 1 CELL BASED THERAPIES LEGAL & REGULATORY Presentatienaam datum Presentator www.axonadvocaten.nl Slide 2 Begin with the end in mind Determine regulatory qualification…