4th Annual Conference on Drug Discovery and Clinical Development in India: Scientific and Regulatory Advances Across Borders

Date(s) And Time(s):
Nov 15 2009 8:00AM - Nov 18 2009 5:00PM

Location:
Hotel the Sheraton
District Centre
Saket
New Delhi 110017
New Delhi
India

Overview:

CONFERENCE TOPICS

Pre-Conference Workshops:

· Registration of Drugs and Biologics in Canada
· Overview of Global Medical Device Regulations
· Regulatory Policy roundtable

Update on Global Regulatory Landscape:

· Regulatory Strategic Discussion with Global Regulatory Leaders (Invitees: DCGI, FDA, EMEA, PMDA, Health Canada, TGA, and MHRA)
· Development of medical devices: global regulatory requirements
· Opportunities for establishing globally centralized laboratories in India.
· India’s Patent Laws and their impact on biopharmaceutical industry 4 years after promulgation
· India vs. ICH regulatory framework for safety reporting

Drug Discovery:

· R&D Strategy: Value creation through strategic partnerships
· Translational medicine (and Biomarkers)
· Opportunities for India to become one of the global leaders in Innovative R&D

Quality:

· Quality Assurance in a Global Economy: Challenges and Opportunities

Pharmacology and Toxicology:

· Preclinical considerations for development and global registration of drugs and biologics

Development of Biologics:
· CMC, Preclinical and Clinical development of biotechnology-derived products
· Can India unlock the potential for worldwide availability of Biosimilars
· Vaccines: Regulatory challenges in development

Clinical Trials:

· Optimization of early and late phase trials

· Expanding the concept of Phase I Clinical Research

· Clinical trials in pediatrics: Role of incentives and/or exclusivity in promoting pediatric development for existing drugs and new molecular entities

· India’s potential in rare and neglected diseases: Clinical and Regulatory considerations

· Exploiting Pharmacogenomics for Personalized Medicine: Avesthagenome Project – A study of the Parsi population of India

· Case studies for acceptability of clinical data from India for registration in ICH regions

· Clinical trials in Ayurvedic medicine: Prospects and challenges in development

· Antigene/Antisense Therapeutics: Current Status, Promise and Opportunities

· Quality/Regulatory monitoring of clinical supply

· Site and Investigator Experience in India

Pharmacovigilance:

· Signal detection, assessment and characterization of serious adverse events

Biopharmaceutics:

· Biopharmaceutical classification system (BCS)

Bioinformatics and Data Management:

· Current status and future prospects of bioinformatics in India

· Clinical data management in 2010 and beyond: India as a Leader

Combination Products:

· Regulatory considerations for global development and registration of combination products

Drug Delivery:

· Novel drug delivery systems: Value creation through new formulations and delivery mechanisms

Value Proposition in Clinical Research:

· Risk/benefit assessment of clinical trials – by regulatory authorities, ethics committees, subjects

· Human subject protection – including ethics committees responsibilities and validation; clinical trial insurance

· Conflicts of interest in clinical trials

·  Legal liabilities on clinical researchers

· Training of all stakeholders in clinical research

· Societal and media perceptions – bringing about understanding through communication

· Harmonization of regulatory standards used in clinical research with global requirements

· Meeting global clinical 'quality' standards

· Stem cells and gene therapy: Legal and ethical challenges

Regulatory:

· Engaging with regulators during drug development: current status and recommendations for the future

CHAIR FOR SCIENTIFIC ADVISORY BOARD

AND PROGRAM COMMITTEE

SATISH C. TRIPATHI, PHD, RAC

President, Biomedical Consulting International, Inc.

Chicago - New York - Mumbai

SCIENTIFIC ADVISORY BOARD COMMITTEE

PUSHPA M. BHARGAVA, PHD

Formerly Director, Center for Cellular and Molecular Biology,

India

PROFESSOR SURESH K. GUPTA, PHD, DSc

Dean & Director General, Institute of Clinical Research (India)

NANDINI KUMAR, MD

Consultant, Indian Council of Medical Research, New Delhi

NARGES MAHALUXMIVALA, MD

Physician Consultant and formerly Senior Advisor, Clinical

Development Services, Quintiles India

PROFESSOR SHIRLEY MURPHY, MD

Professor Emeritus, University of New Mexico School of

Medicine, Albuquerque and formerly Director, Office of

Translational Sciences, CDER, FDA, USA

PREM K. NARANG, PHD

Vice President, Head-Global Regulatory Affairs, Medical

Diagnostics, General Electric, USA

SUPRIYA SHARMA, MD, MPH, FRCPC

Director General, Therapeutic Products Directorate, Health

Canada

STEPHEN E. WILSON, DRPH, CAPT. USPHS

Director, Division of Biometrics III, CDER, FDA, USA