Session Topics

Session I

9:30 - 9:45 AM

Welcome and Introduction to the Conference

Chairman, Program Committee
Professor S. K. Gupta,
PhD Dean & Director General,
Institute of Clinical Research, India

Keynote Address

9:45 - 10:05 AM

Clinical Trial: New Horizon - India

Dr. Surinder Singh, MD
Drugs Controller General of India,
Ministry of Health and Family Welfare,
Govt. of India

10:05 - 10:25 AM

Government Initiatives for Promoting Clinical Development in India

Mr. Debasish Panda, IAS
Joint Secretary, Ministry of Health &
Family Welfare, Govt. of India

Session II

10:25 - 10:40 AM

ICRI 2008 Award Winners

In order to fulfill its mission of Promoting Ethical Clinical Research in India, ICRI recognizes the outstanding contributions made by individuals and honour them with awards on the recommendation of the jury of experts. ICRI Award 2008 goes to:

Life Time Achievement Award

Dr. (Mrs.) Nilima , MD, DM
Ex Dean - Seth G. S. Medical College and
KEM Hospital and Director, Maharashtra
University of Health Sciences, Nasik

Distinguished Investigator Award

Dr. S. H. Advani, MD
Medical Oncologist
Former Chief Consultant Tata Memorial Hospital, Mumbai




10:40 - 11:00 AM Morning Refreshment and Tea Break

Session III

Special Plenary Presentation

11:00 - 11:20 AM

Clinical Trials Conducted Outside United States:
New USA - FDA Regulations

Professor Joshua Sharlin, PhD
President, FDA Smart Inc., Former US FDA
Drug Reviewers, Washington,
DC. World Class trainer to over 3500
attendance during the last 10 years on
mission critical topics to deliver US FDA
regulatory compliance Master Consultant to
Global Pharmaceutical, Biotech Biologics and
Medical Devices Companies.

Session IV

Bioethics : Protection of Human Subjects

Multi Track Sessions
Accountability in Clinical Research and public confidence is of
paramount importance. Informed Consent, Transparency and
Protection of Human Subjects are of paramount importance.
This session will focus on various related issues.

11:20 - 11:40 AM

Drug Development: Ethics and Public Confidence is a Must

Professor Adil Shamoo, PhD
Chief Editor Accountability in
Research University of Maryland School of
Medicine, USA

11:40 - 12:00 PM

Confronting the Compliance Myth: How Can We Really
Protect Human Subjects?

Professor Greg Koski, Ph.D, MD
Senior Scientist, Institute Health Policy
Massachusetts General Hospital and
Associate Professor of Anesthesia Harvard
Medical School, USA

12:00 - 12:20 PM

Ethical Decision Making in Clinical Research Management...
Listening to your Moral Imperative

Mr. Mark Koscin, M.T., CCRA, ACRP
Vice President of Human Research
Technologies Inc. USA

12:20 - 12:40 PM

Exploring Ethical Issues Beyond Good Clinical (Research) Practice

Mr. Thomas E. Merchant, ESQ
Former Vice President
Glaxo SmithKline, USA

Session V

Plenary Session

12:40 - 1:00 PM

Post Marketing Surveillance & Risk Management

Dr. Stanley Edlavitch
Professor, Epidemiology and Director
Graduate Training, School of Medicine
University of Missouri Kansas City, USA




1:00 - 1:40 PM Networking Luncheon and ICRI Students Poster Presentation

Session VI

Special Plenary Session

1:40 - 2:00 PM

Initiatives of DST in Promoting Drug Discovery and Clinical Research in India

Dr. G. S. Samathanam Advisor
Department of Science & Technology (DST)
New Delhi, India

Session VII

Clinical Research & Development

2:00 - 2:20 PM

CRO Opportunities in India

Dr. Kiran Marthak, MD,
Director, Veeda, India

2:20 - 2:40 PM

Beyond Cost and Time Savings: What Can India Offer for Drug Development

Dr. Nermeen Varawalla MD,
DPhil (Oxon), MBA Vice President,
Scientific & Medical Affairs
PRA International, USA

2:40 - 3:00 PM

Current Scenario of CR in India: Where it is heading

Dr. Sadhna Joglekar
Vice President, Medical and Clinical Research
Glaxo Smithkline, India

3:00 - 3:20 PM

Emerging Challenges in Clinical Research in India

Dr. Anand Bidarkar
Vice President – Business Development
SIRO Clinpharm, India

Session VIII

Capacity Building In Clinical Research

3:20 - 3:40 PM

Clinical Research Professionals in India: A Case for Continuous Skill Building

Dr. Mohanish Anand
Head - Clinical Research
Pfizer, India

3:40 - 4:00 PM

Challenges of Time Management in a Clinical Trial Project

Dr. Arun D. Bhatt
President,
ClinInvent Research Pvt. Ltd., India





4:00 - 4:15 PM Evening Refreshment and Tea Break

4:15 - 4:35 PM

Changing Roles of CRA

Dr. Sonal Vora
Sr. Director, Clinical Operations
Sanofi Aventis, India

4:35 - 4:55 PM

Current Challenges in Creating Capabilities and Scales in Clinical Research

Dr. Kratish Boppana
Sr. Vice President
Manipal Acunova, India

Session IX

India Advantage and Outsourcing Opportunities
Informed Consent Process and Regulations

4:55 - 5:15 PM

Realizing India Advantage in Clinical Trial

Dr. Vasudeo Ginde
President
Igate, India

5:15 - 5:35 PM

Hospitals and Clinical Research: Does it Improve Patient Care?

Dr. Amit Varma,
COO and Director Critical Care Medicine
Fortis Healthcare Ltd., Delhi India






4:00 - 4:15 PM Evening Refreshment and Tea Break

5:35 - 5:55 PM

Clinical Trials: A Clinician's Perspective

Dr. Vijay Kher
Director Nephrology & Renal Transplantation
Fortis Healthcare Ltd., Delhi, India

5:55 - 6:15 PM

Current Developments in Indian Pharmacopoeia for
Quality Assurance

Dr. G. N. Singh
Director
IPCL, India

6:45 PM Onwards Welcome Reception and Cocktail Dinner (For Industry Delegates and Sponsors)