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Health & Medicine Microbiology and Immunology

1. Program Coordinator: Laura Kasman, Ph.D. [email_address] 2. M&I program currently 17 Ph.D. students 4 MD/Ph.D. students 1 DMD/Ph.D. student 2 Masters students 15 Departmental…

Documents EUFETS_CompanyPresentationDEC14

1. WELCOME TO EUFETS GMBHYour Provider ofIntegrated Product Development Services for Cell & Gene TherapyEUFETS GmbH - A Company of BioNTech AG 2. EUFETS is part of BioNTech…

Documents 37168

4 Biological Products: Manufacturing, Handling, Packaging and Storage Nahla S. Barakat King Saud University, College of Pharmacy, Dept. of Pharmaceutics, Saudi Arabia 1.…

Documents 16 th Annual NIH SBIR/STTR Conference Functional Down-to-Earth Advice for understanding the FDA...

Slide 1 16 th Annual NIH SBIR/STTR Conference Functional Down-to-Earth Advice for understanding the FDA Chris Sasiela, PhD, RAC NHLBI Office of Translational Alliances and…

Documents FDA Oversight of Cell Therapy Clinical Trials Celia Witten, Ph.D., M.D. Office Director, Office of.....

Slide 1 FDA Oversight of Cell Therapy Clinical Trials Celia Witten, Ph.D., M.D. Office Director, Office of Cellular, Tissue, and Gene Therapies CBER/FDA ISSCR/CIRM/ISCT Workshop…

Documents European Parliament Advanced Therapies Hearing May 11, 2006 Advanced Therapies The proposed EU...

Slide 1 European Parliament Advanced Therapies Hearing May 11, 2006 Advanced Therapies The proposed EU regulation from the viewpoint of a Pharmaceutical company with experience…

Documents OCTGT Guidance Document Update

OCTGT Guidance Document Update Rachael Anatol, Ph.D. Associate Director for Policy-New Legislation February 26, 2014 Outline Good Guidance Practices Guidance basics Guidances…

Documents Deborah Hursh, Ph.D. Office of Cellular, Tissue, and Gene Therapies

Mitochondrial Manipulation Technology in Assisted Reproduction For the Prevention of Transmission of Mitochondrial Disease or Treatment of Infertility Deborah Hursh, Ph.D.…

Documents Innovation Through Collaboration: Why the CSS Working Groups are Important to the FDA Steve Wilson,....

Innovation Through Collaboration: Why the CSS Working Groups are Important to the FDA Steve Wilson, DrPH, CAPT USPHS Director, FDA/CDER/OTS/OB/DBIII 2014 Computational Science…

Documents The FDA Review Process

The FDA Review Process Dan Takefman, PhD Chief, Gene Therapy Branch DCGT/OCTGT/CBER/FDA IOM Meeting 6/4/13 Overview IND Review Process Regulatory framework Discipline review…