Pharmaceutical Regulatory Affairs: Open Access

4^th International Conference on Pharmaceutical Regulatory Affairs

September 08-10, 2014 DoubleTree by Hilton Hotel Raleigh-Brownstone-University, USA

Scientific Tracks Abstracts

• Assessment of the antibacterial activity of actinomycetes isolated from terrestrial soil of King Saud University campus

  Arunachalam Chinnathambi

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• Extractables and leachables: Regulatory perceptive

  Kishore Kumar Hotha

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• Challenges and latest regulations about medical devices in Middle East region

  Sara Hegazi

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• Implementation of changes aligned to regulatory framework

  Mohammad Iqbal Hossain

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• Pharmabiotics: A regulatory hurdle in Europe

  Magali Cordaillat-Simmons

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• Combining nanotheranostics and photomedicine: Design and synthesis of nanophotomedicine

  Jayeeta Bhaumik, Joydev K Laha and Uttam C Banerjee

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• Have FDA expedited programs really shortened drug review time? an analysis of newly approved therapies and how FDA expedited programs have impacted drug development timelines

  Krasimira Pekova

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• Key considerations of orphan products designation and registration regulation

  Mona Mohammed

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• Consent decree, why, how, and what to do?

  Adam Sabouni

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• Leaderships role in implementing and maintaining pharmaceutical quality systems

  Brian Hill

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• Combination products and convergence: An overview of clinical benefits, regulatory issues & manufacturing challenges

  Michael Drues

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• Business and regulatory environment of biopharmaceuticals and biosimilars in Latin America

  Ricardo Ibarra-Cabrera

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• Herbal medicines: Product licence to traditional herbal registration in the UK

  Mariam Aslam

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• Implementing a periodic validation review program: A case study

  Charles Stock

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• Biomedical nanotechnology: The smaller the thing, the bigger the challenge !

  Michael Drues

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• CAPA program management via the DMAIC methodology

  Roger E Gould

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• Applied QbD hybrid approach: A case study

  Charles Stock

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• Validation of software as a service ERP system: Compliant use of cloud computing

  David Hawley

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• Investigating problems, applying risk management and creating sustainable solutions

  Brian Hill

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• Global regulatory best practices: Companion diagnostics

  Abhishek Harde

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• Improving clinical research operations: Optimizing the use of current biomarkers

  Augustine Onyeaghala

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• Hidden danger of few extensively used vegetables and herbs renowned for the treatment of diabetes

  Nasreen Fatima

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• A guide to an effective clinical trial protocol in cGMP & cGCP as a tool for sustenance of ethical principles and regulatory requirements in the pharmaceutical and research industry

  Peter Odeh

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• Production and analysis of biosimilars and follow on biologics in developing countries

  Wael Ebied

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• Risk based intercultural property assessment

  Jerry Xu

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• USP monograph modernization-procedure review and development

  Donald Min

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• Regulatory roadmap for initiating a cell therapy drug into clinical trials in the US

  William Lee

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• A quality and regulatory it strategy for multi division life science companies

  Roger E Gould

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• A minimally invasive needle endoscope for the visualization of deep brain tissues in vivo

  Jun Ki Kim

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• Pharmaceutics & novel drug delivery systems

  Tariq Jamshaid

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• An investigation about complex formation tendencies of Fe(III) and Fe(II) with anti-Parkinsoniandrug, levodopa, (-)-3-(3,4-dihydroxyphenyl)-L-alanine at physiological pH

  Syed Zafar A Zaidi, Nasreen Fatima and Iftikhar I Naqvi

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• Regulatory challenges of nano therapeutics

  Arpit A Patel

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• Saudi pharmaceutical market and pharmacy education

  Naser L Rezk and Hussam Baghdady

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• Required amendments in the cosmetic products legislation in India

  Gupta R N and Kumar Sujit

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• Quality risk management system

  Rashid Mahmood

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• CHP-Complaint handling process an approach in response to the dissatisfaction regarding substandard and a counterfeit drug

  Syed Zafar Abbas Zaidi

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