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

Accepted Abstracts

• Problems of enforcements of regulations on pharmaceutical industry in Bangladesh

  Abdullah Al Faruque

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• Regulatory Affairs in emerging markets

  Ahmed Muhammad Farag

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• Engineering algorithms to classify, detect, localize breast and leg tumors

  Ahmad Taha Abdulsadda

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• EU Medical device regulation

  Ajrulla Zuta

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• Medication review procedures in European countries

  Anna Bulajeva Anna

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• Nanosimilars: Overview of critical regulatory attributes

  Arpit A Patel

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• Active substance master files: What is changing in the EU regulatory framework for drug substances?

  Laura Castagno

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• Green tea extract: Its potential protective effect on bleomycin induced lung injuries in rats

  Azza H El-Medany and Jamila EL-Medany

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• Comparative study between angiotensin converting enzyme inhibitors and angiotensin receptor blockers on ulcerative colitis induced experimentally in rats

  Azza H El-Medany, Hanan H Hagar and Jamila H El-Medany

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• Effective methods for software and systems integration for software companies and institutions

  Boyd L Summers

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• The importance of software engineering reviews and audits conducted and performed for software companies & institutions

  Boyd L Summers

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• Regulatory affairs in herbal products - Indian perspective

  D D Patra

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• Novel controlled release microsponges for topical infections

  Gannu Praveen Kumar and Venu Nani

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• A retrospective analysis of prescribing practices through WHO prescribing indicators at four selected hospitals of west Ethiopia

  Jimma Likisa Lenjisa and Tadese Haile Fereja

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• The U.S. food and drug administration’s regulation of brand and generic drug products

  Karl M Nobert

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• Is there a need for an intellectual property (IP) policy in South Africa?

  Makhapa Makhafola

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• Common technical document-Widely accepted reviewer friendly common dossier format for submission to health authorities for approval of pharmaceuticals

  Manu Babbar

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• The delay in the examination of applications for registration at ANVISA and lawsuits in Brazil

  Marcio Raposo de Almeida

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• The precautionary principle and its metamorphosis

  Margherita Paola Poto

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• Generic pharmaceutical market of Japan-Regulatory policy leading to successful evolution

  Mihajlo B Jakovljevic

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• Strengthening regional collaboration among ASEAN regulatory laboratories to ensure quality assurance in pharmaceuticals

  Maria Soledad Lopez-Distor

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• Biopharmaceutics classification system based studies to establish biowaiver status of levofloxacin brands

  Muhammad Faisal Baig

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• Regulation of regulatory affairs regarding veterinary products in MENA region

  Nacef Hacene Chahir

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• Quality by design- Regulatory considerations for pharmaceutical analytical methods

  M V Narendra Kumar Talluri

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• The European paediatric regulation: Strategies for effective negotiation and agreement of a pragmatic paediatric investigation plan (PIP)

  Natalie Thomas

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• Influence of ASEAN cosmetics community (AEC) 2015 in SEA and its impact on the landscape of the personal care and cosmetic industry; cosmetics regulatory scheme implementation

  Neeranard Jinachai

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• Clinical trial agreements: Important or just one more study document?

  JoAnn P Pfeiffer

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• Solubility enhancing of sertraline using liquid-solid technique

  S Pradeepti

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• Cellular transformation and gene expression during adhesion deprivation

  Rajeswari Jinka

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• Regulatory requirements for API - CTD, CEP and active substance master file in EU

  Rikul Patel

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• Indian Pollution Control Board’s regulations leading to green chemistry real world case in Indian pharmaceutical industry

  R K Sharma

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• Quality risk management methodology in pharmaceutical industry (ICH Q9/FDA/WHO)

  Rober Remon Saad Habashy

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• Regulatory framework for pharmaceuticals as endocrine disruptors: A critical review

  Roeb Garcia-Arrazola

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• Required amendments in the cosmetic products legislation in India

  Kumar Sujit and Gupta R N

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• Risk based internal audit- an effective approach

  Shabbir Dhamani

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• Key implications in Brazilian regulatory environment from the innovation point of view

  Suzana de Lima R de Deus

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• Prevalence and antimicrobial susceptibility pattern and methicillin resistant Staphylococcus aureus isolated from raw bulk milk samples from smallholder dairy farms in Jimma, Ethiopia

  Tadele Tolosaa, Girma Kebede, Joren Verbeke, Sofie Piepers, Karlien Supré and Sarne De Vliegher

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• Oversight of clinical investigations- A risk based approach to monitoring

  Taghrid Obied

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• Efficiency in the context of data quality: The role of design and technology

  Vikram Kukkadi

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• Regional factors impairing multicentral clinical trial results

  Vladimir Popov

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