INTERNATIONAL PHARMA REGULATORY CONFERENCE

OMICS Group is delighted to invite you to attend the 2nd International Conference and Exhibition on Pharmaceutical Regulatory Affairs which is to be held on 23-24 November 2012 HICC, Hyderabad, India.

Session Chair
Session Introduction

Title: The regulation of herbal medicines in Brazil

Laerte DallAgnol DALL Solucoes Analticas e Empresariais, Brazil

Download Abstract & Biography Title: Cassia occidentalis: Effect on skin wound healing in mice
induced by Bootrops moojeni venom Leila Maria Leal Parente Federal University of Goias, Brazil

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Title: Global scenario of traditional herbal medicines Impact on

ayurveda Deepika Gunawant Max Ventures, India

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Title: A philosophical and scientific approach to evaluate preventive

& curative medicinal uses of herbal, natural products, food additives, neutraceuticals (ayurveda) and pharmaceuticals (allopath) Dev lal Sharma Omatek lab Pvt. Ltd, India

Download Abstract & Biography Title: Ethnopharmacology and metabolomics: A multidisciplinary

approach for drug discovery from natural sources U.K. Patil Peoples University, India

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Title: Quality assurance of herbal medicinal products: Past, present

& future Tejal R. Gandhi Anand Pharmacy College, India

Download Abstract & Biography Title: Development of herbal formulations through traditional
knowledge and scientific validation Dayanandan Mani University of Lucknow, India

Download Abstract & Biography Title: Development and initial standardization of ayurveda child
personality inventory Suchitra patil SVYASA University, India

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Track 7: Safety and Quality Regulation

Track 7-1 New drug development Track 7-2 Medical device development Track 7-3 Biologics development Track 7-4 Prescription drugs Track 7-5 Drug dosage and labelling

Session Chair
Session Introduction

Title: Discovery of new drug efflux transporters in human cornea prominence in ocular drug delivery and decreased blindness Pradeep K. Karla Howard University, USA

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Title: Silica-based products: New tools to simplify synthesis,

purification & metal removal N. Rajasekar SiliCycle Inc., Canada

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Title: Medication errors in pediatric population: Magnitude and

interventions Deepa Arora Lupin Limited, India

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Title: Explorations of power laws in pharmacy: Implications for

Adverse Drug Events (ADEs) Rao S. Pippalla Talla Padmavathi College of Pharmacy, India

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Title: Tanshinone IIA could inhibit human hepatocellular carcinoma

Hep-G2 cells through inducing ER stress in vitro Chin-Cheng Su Changhua Christian Hospital, Taiwan

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Track 8: Business and Law Enforcement and Education

Track 8-1 The business of pharmacy, medicine and biotechnology Track 8-2 Understanding the health care landscape Track 8-3 Regulatory culture in food and drug administration Track 8-4 Biomedical product development: From boardroom to market Track 8-5 Importance of personnel training and education in regulatory affairs

Session Chair
Session Introduction

Title: How does quality impact business success?

Sunita Sharma Ocimum Bio Solutions, USA

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Title: Saudi pharmaceutical market; Current, future and R&D

Naser L. Rezk King Saud bin Abdul-Aziz University for Health Sciences, KSA

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Title: Medical representatives with gifts: To whom to give and why?

Naseem Akhtar Qureshi Ministry of Health, Saudi Arabia

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Title: Kaleidoscope of healthcare

Devinder Pal Catalyst Pharma Consulting, India

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Title: Importance of personnel training and education in Regulatory

Affairs Sapna L Kanth Liquent Software Private Limited, India

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Title: Holistic pharma for all

S. V. Eswaran University of Delhi, India

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Title: Regulatory affairs a challenge to professionals

S N Kilikar Pharma Consultant, India

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Track 9: Biomedical Intellectual Property Management

Track 9-1 Global biotechnology product registration: E.U., U.S. product regulation Track 9-2 Quality (chemistry/manufacturing Controls), safety and efficacy issues Track 9-3 Intellectual property law for generics and innovator rights Track 9-4 Patents in the pharmaceutical industry: Legal & ethical Issues

Session Chair
Session Introduction

Title: Challenges in patentability for incremental innovation in the

Pharmaceutical industry Komal Shah-Bhukhanwala Innovar IP, India

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Title: The rise of Indian generics, globally and at home

Kamaraju Chitrapu Indian School of Business, India

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Title: On-site audits approach: A tool for Quality Risk Management

V. Siva Kumar Micro Labs Limited, India

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Title: Patenting in India balancing access to affordable medicines

and patents for pharmaceutical innovators Manthan D Janodia Manipal College of Pharmaceutical Sciences, India

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Title: Patent law compliant research methodology in pharmaceutical

research Vipin Mathur Lachoo Memorial College of Science & Technology, India

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Title: Optimising the bang for buck in the realm of therapeutic

ontology using patent and XP documents Sankar Sundaram JSS University, India

Download Abstract & Biography Title: Patents in Indian pharmaceutical industry: Legal and ethical
issues B. S. Kuchekar MAEERs Maharashtra Institute of Pharmacy, India

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Title: Corrective action & preventive action (capa system) and

regulatory inspection S N Kilikar Pharma Consultant, India

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Track 10: Regulatory Compliances in Health Care

Track 10-1 FDA and EU regulatory policies Track 10-2 Regulatory aspects of NDA and ANDA: Regulatory filing and submissions Track 10-3 Compliance programs and policy guides Track 10-4 GMP, GCP, GLP and GRP's

Session Chair
Session Introduction

Title: EU Regulatory Affairs

Nagesh Maddula Biovision Consultants Ltd., UK

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Title: European regulatory framework for drug approval through the

centralized system Andrea Laslop Austrian Agency for Health and Food Safety, Austria

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Title: Informed consent process, the bane of unethical clinical

research Augustine Onyeaghala University College Hospital, Nigeria

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Title: A convergence of regulatory policies at FDA and EMA

Mallika Rajasekaran Aris Global Software Private Limited, India

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Title: Regulatory perspectives on drug dissolution testing

Deepika Agarwal Dr. Reddys Laboratories Ltd., India

Download Abstract & Biography Title: Managing US Food and Drug Administration inspections at
Indian clinical trial sites- CRO perspective Ashutosh Jani Accutest Research Laboratories, India

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Title: Overcoming the challenge of differing guidelines for

compliance with GMP by different authorities Mithilesh Trivedi OmniActive Health Technologies Ltd, India

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Title: Understanding facility validation for GMP compliance

J. Ramniwas Sai Pharma Solutions Inc., India

Download Abstract & Biography Title: Need of Good Laboratory Practice in pharma industry
P. V. Mohanan Sree Chitra Tirunal Institute for Medical Sciences and Technology, India

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Track 11: Novel Strategies for Growth in the Pharma and Regulatory Environment

Track 11-1 Regulatory issues, quality control, and business development Track 11-2 Clinical trials in emerging markets Track 11-3 Benefit/risk assessment during drug development Track 11-4 Strategic development towards FDA approval Track 11-5 Regulatory challenges in nano and biotech therapeutics

Session Chair
Session Introduction

Title: Effective regulatory information management

Bobby George Reliance Life Sciences, India

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Title: A country perspective in exploring the links between hospital

pharmacies and pharmaceutical industry: A case study application Ana Margarida Santos Bravo Lisbon University Institute, Portugal

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Title: Pre-analytics- a challenge less heeded

Aparna Jha Ahuja SRL Diagnostics, India

Download Abstract & Biography Title: Facelift of CDSCO

Mohammad Shahbaz Alam Meher Pharma International, India

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Title: PEGylation products, mono and combination therapiesIncreasingly clearing regulatory hurdles and reaching market Sandeep Arora Chitkara university, India

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Title: New drug application under section 505(b) (2): Preferred

USFDA regulatory approval pathway Balaram Gajra Charotar University of Science and Technology, India

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