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

Scientific Tracks Abstracts

• The master validation plan: A vision of things to come

  Steven Mattos

  PDF HTML

• Points to consider when managing regulatory submissions in Asia Pacific countries

  Linda Yang

  PDF HTML

• Complaints handling and post marketing surveillance

  Harshit Thakkar

  PDF HTML

• USA and EU regulatory submissions for veterinary medicines

  Karolina Bate

  PDF HTML

• Regulations in the emerging market of nutraceuticals: From paradigms to practice

  Kerry Diaz

  PDF HTML

• Who does design control best? (Successful medical device manufacturers do)

  Steve Jwanouskos

  PDF HTML

• Combination products: Current regulations, challenges and global trends

  Chitra Edwin

  PDF HTML

• Overview and successful strategies for INDs and NDAs

  Michelle Carpenter

  PDF HTML

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

  JoAnn P. Pfeiffer

  PDF HTML

• Regulatory impact of applying computational predictive models to design, develop, and commercialize drug products

  Mary T. am Ende

  PDF HTML

• Regulatory affairs in emerging markets- Understanding the importance of local knowledge strategy identification

  Mamoona Firdous Naqvi

  PDF HTML

• FDA process validation guidance & principals Vs EMA guidance

  Rober Remon Saad Habashy

  PDF HTML

• Globalization of pharmaceutical industry - Need of the hour

  Sunny Chopra

  PDF HTML

• Current trends in computerized system validation - Challenges and solutions

  Garikapati Pavan Kumar

  PDF HTML

• Challenges in providing adequate high-level education in regulatory affairs, especially in view of small countries

  Elvi Metsaranta

  PDF HTML

• Cleaning validation

  Rashid Mahmood

  PDF HTML

• Liposome characterization required for regulatory approvals

  Donald Kruppa

  PDF HTML

• Effective methods for software and systems integration

  Boyd L. Summers

  PDF HTML

• Australian pharmaceutical patent system under review - To ‘balance’ the interests of pharmaceutical product innovators and the generics industry

  Gint Silins

  PDF HTML

• Medicines regulation in Australia and New Zealand - Unique and changing; An industry perspective

  John L. Miller

  PDF HTML

• Best industry practices - Audits and inspection

  Kahl Melodie

  PDF HTML

• External price referencing system - Implementation in Albania and consequences

  Ledia Cikopana

  PDF HTML

• Good distribution practices (cGDP) and related regulatory affairs at the Brazilian supply chain

  Frederico Rapussi

  PDF HTML

• The quality journey; From the Stone Age to modern times, and the lessons learned

  Mohammed R. Khan

  PDF HTML

• Analytical Test Method Validation (AMV) of Finished Pharmaceutical Products (FPP) & system suitability requirements

  Rober Remon Saad Habashy

  PDF HTML

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

  William Lee

  PDF HTML

• Regulatory submissions for blood products at Saudi FDA

  Ali Mohammed Alsamil

  PDF HTML

• In vivo antidiarrheal and ex-vivo spasmolytic activities of the aqueous extract of the roots of Echinops kebericho Mesfin in rodents and isolated guinea-pig ileum

  Fisseha Shiferie

  PDF HTML

• Quality management and accreditation in a mixed research and clinical analytical laboratory setting

  Netta Fulga

  PDF HTML

• Biosimilars and non-innovator biotherapeutics in MENA region: Opportunities and challenges

  Ibrahim Aljuffali

  PDF HTML

• Remote internal quality audits - Effective and efficient

  Garikapati Pavan Kumar

  PDF HTML

• Electronic compliance monitoring and return on investment

  Allan Wilson

  PDF HTML

• Strategic management of global post approval regulatory activities

  Linda Yang

  PDF HTML

• Regulatory strategy should be business strategy

  Rama K. Pidaparti

  PDF HTML

• Pricing policy for a patent medicine? Need for changing the framework of rewarding an innovation

  Anantha Naik Nagappa

  PDF HTML

• Quality risk management system

  Rashid Mahmood

  PDF HTML

• Management of IP in a multi - collaborative framework: DST/Mintek nanotechnology innovation centre as a case study

  Makhapa Makhafola

  PDF HTML

• Problems encountered by third world countries especially Pakistan in pharmaceutical regulatory affairs and their remedies

  Shoaib Ahmed

  PDF HTML