International Summit on GMP & GCP:USA, Europe, Japan, Asia Pacific (GMP & GCP-2012)

Venue: DoubleTree by Hilton Philadelphia Center City, USA.

Location: Philadelphia, pennsylvania, United States

Event Date/Time: Dec 03, 2012 End Date/Time: Dec 05, 2012
Registration Date: Sep 14, 2012
Early Registration Date: Aug 13, 2012
Abstract Submission Date: Jun 25, 2012
Paper Submission Date: Jun 25, 2012
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Description

OMICS Group cordially invites all the participants across the globe to attend the International Summit on GMP & GCP: USA, Europe, Japan, Asia Pacific during December 3-5, 2012 at DoubleTree by Hilton Philadelphia Center City, USA.

GMP&GCP-2012 is a remarkable event which brings together a unique International mix of large and medium Health & Research, pharmaceutical companies, clinical research organizations, leading universities and research institutions making the conference a perfect platform to share experience, foster collaborations across industry and academia, and evaluate emerging technologies across the globe.

Venue

Additional Information

OMICS Group International Summit on GMP & GCP: USA, Europe, Japan, Asia Pacific paves path for accelerating scientific discoveries with the theme of "Current Issues and challenges in the Implementation of GMP & GCP regulations". GMP & GCP-2012 is comprised of 9 tracks and 47 sessions designed to offer comprehensive sessions that address current issues in GMP & GCP. Submit your Abstract to any of the following Tracks. All related Abstracts are accepted. Register now for the conference by choosing an appropriate package suitable to you. Abstract Submission Register Executive Editors Gregory Luke Larkin Yale University School of Medicine, USA Shufeng Zhou University of South Florida, USA Karim A. Alkadhi University of Houston, USA Mark A. Rothstein University of Louisville School of Medicine, USA Q. Ping Dou Wayne State University, USA Peter Robert Martin Vanderbilt Psychiatric Hospital, USA Y. W. Francis Lam University of Texas, USA William R. Ravis Auburn University, USA Christina Puchalski George Washington University School of Medicine, USA George Khushf University of South Carolina, USA Francesco Marotta Texas University, USA Track 1: Current Regulations and Quality Standards Track 1-1 FDA regulations and CFR Track 1-2 EU-GMP guidelines Track 1-3 WHO-GMP guidelines Track 1-4 Role of Pharmaceutical Inspection Convention and Co-operation Scheme (PIC/S) Track 1-5 Asia Pacific: GMP Regulations Track 2: Current GMP guidelines for Pharmaceuticals Track 2-1 GMP for Active Pharmaceutical Ingredients (API) Track 2-2 Ophthalmic solutions Track 2-3 Parenterals Track 2-4 Topical solutions Track 2-5 Recombinant DNA products and cellular therapeutic agents Track 2-6 Licensing in pharmaceutical production Track 2-7 Packaging materials Track 3: GLP, GCP, and cGMP Track 3-1 Food processing technologies Track 3-2 Finished products management Track 3-3 Recall system under GMP Track 3-4 Marketing authorizations Track 3-5 Standard operating procedures (SOP) Track 3-6 Biological waste management Track 4: Clinical Trial Regulations Track 4-1 Regulatory approval and role of FDA in GLP Track 4-2 GLP's in pre-clinical studies Track 4-3 Global current techniques to improve clinical trial practices Track 4-4 Quality and risk management Track 4-5 Challenges and solutions of clinical trials Track 4-6 Pharmaceutical clinical trial legislation Track 5: Good Clinical Practice Track 5-1 Role of ICH in designing GCP principles Track 5-2 Institutional review boards and the informed consent process Track 5-3 Responsibilities of sponsors and investigators Track 5-4 Ethical aspects in clinical trials Track 5-5 Post-approval regulatory requirements Track 6: Investigational Medicinal Products Track 6-1 Regulatory requirements for IMPs Track 6-2 Inspection at investigational sites Track 6-3 Requirements for labelling and packaging Track 6-4 Non IMP requirements Track 7: Legal Requirements for Medical Devices Track 7-1 Regulatory requirements Track 7-2 Design controls Track 7-3 Validation/qualification Track 7-4 Regulatory audits Track 7-5 CAPA and risk management Track 8: Computational strategies in GMP/GCP Track 8-1 Implementation of computerised systems Track 8-2 Suppliers, software developers, and quality management Track 8-3 QMS and software standards attributes Track 8-4 Computational validation and audits Track 8-5 GAMP validation approach Track 9: GMP Meets GCP Track 9-1 Interface between GMP and GCP Track 9-2 GMP and GCP inspections Track 9-3 Role of qualified person in GMP and GCP Track 9-4 Quality indicators in GMP/GCP

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