Pharmaceutical Regulatory Affairs: Open Access

3^rd International Conference on Pharmaceutical Regulatory Affairs

October 21-23, 2013 DoubleTree by Hilton Hotel San Francisco Airport, CA, USA

Accepted Abstracts

• Europe - New regulations - What impact will the proposed new regulations in Europe have for medical device manufacturer?

  Toni Kennet Jorgensen

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• Embracing recent strategies in global regulatory affairs

  Paschal Iwuh

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• Chirality in pharmaceutical product development: A regulatory perceptive

  Kishore Kumar Hotha

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• Asia and ASEAN, what will be the result of all the harmonization effort going on in the Asian markets, and how should we as manufacturer deal with all these new regulations?

  Toni Kennet Jorgensen

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• A cost-effective and practical approach to risk-based computerized system validation (CSV) for pharmaceutical and medical devices regulated environments

  Ana Villar

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• Quality control in a qualified laboratory - An essential element to safeguard good quality medicines

  Andreas Wiegand

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• Australian regulatory requirements for cosmetics and personal care

  Belinda Pilmore

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• Evidence supporting efficacy: The good laboratory practices orphan

  L. Bruce Pearce

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• Regulatory environment & process in Turkey

  Cigdem Yilmaz

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• Taking your marketing efforts global

  Dale Cooke

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• Ethical practices in investigative interviewing for compliance and investigations

  Dana Rodden

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• Adherence to IEC62366 may not ensure a successful FDA review: A case study

  Dean Hooper

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• QRM - Design and implementation of an effective quality risk management program

  DeVaughn Edwards

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• A comprehensive report of differences and similarities on guidelines and standards on how to reprocess reusable medical devices by professional standard healthcare organizations, societies and government agency

  Elijah N. Wreh

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• Saudi FDA reporting system - NCMDR

  Essam M. Al Mohandis

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• Regulatory affairs in the Middle East

  Faycal Aberkane

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• Regulatory requirements of drug products for human use in EU & Turkey

  Figen Kabadas

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• The European Union way to cosmetic regulation: A new burden or a new opportunity for the cosmetic industry?

  Giulio Pirotta

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• Regulatory environment in the emerging markets: A focus on Middle East and North Africa in the emerging market region to highlight the recent updates in regulation and its shadow on future business in the region

  Hany Gamal

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• RFID technology and regulations for pharmaceuticals

  Ismail Uysal

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• Key strategic consideration for NCE registration in Asia Pacific countries to reduce drug lag

  Jin Shun

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• Impact of the EMA’s new guideline on setting health based exposure limits for risk identification in the manufacture of different medical medicinal products in shared facilities

  Julian Wilkins

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• Requirements of drug-drug interaction studies in the USA and Europe based on recent regulatory FDA and EMA guidelines

  Karl Ludwig Rost

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• Update on biosimilar pre-market requirements in South-East Asia

  Kenny Peng

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• Regulatory in emerging markets

  Kurt Dehaes

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• Quality system controls for clinical trial development and conduct

  Lee Truax-Bellows

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• Validation for the regulated industries

  Les Schnoll

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• Regulation of natural health products in Canada

  Lionel Pasen

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• Validation of processes in pharmaceutical industry

  Mereyim Bouslikhane

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• Proposal for new legislation in Europe

  Micael Johansson

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• Regulatory harmonization - Updates from the field

  Michele Forzley

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• Web based statistical approaches for risk monitoring of sponsor clinical development programs

  Nicole C. Close and Tyson A. Bellamy

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• Creating a global clinical development strategy & regulatory roadmap leveraging emerging drug development markets

  Nidhi Saxena

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• The relevance of safe final destination and rational prescription of drugs under regulatory issues with inclusion of environmental impact analysis on pharmacoeconomics studies

  Nubia Regina de Oliveira

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• Key performance indicator implementation by regulatory affairs

  Philippe Berclaz

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• New developments in benefit-risk decision-making for Rx to OTC switch

  R. William Soller

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• Development and regulatory strategies to bring vaccines faster to the market

  Rajesh K. Gupta

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• Sourcing generic formulations & OTC drugs from Indian pharmaceutical manufacturers: A GMP fiasco waiting to happen?

  Ram Balani

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• Regulatory affairs as a strategy area - Case of study

  Roberta Rodrigues

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• 5 things a realistic and functional quality system should have

  Rosario Quintero-Vives

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• The new proposal for a regulation on medical devices in the EU - What to expect?

  Salma Michor

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• The facts and figures for Middle East and North Africa (MENA) region: A strategic component of global clinical trials

  Satish Chandra-Nair

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• Quality risk management system

  Shruti U. Bhat

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• Regulatory requirements for pharmaceuticals in China

  Wendy (Wen-Ying) Wang

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