Agenda

Day 1, April 29, 2010

8:00 - 9:00 AM      Continental Breakfast

 

9:00 - 9:30 AM       Opening Remarks/Introductions

                     (Mukesh Kumar, PhD RAC, President, GAIBP & Jan Pierre, MPH, Principal Consultant,

                     Quintiles)

 

9:30 - 10:30 AM     Emerging Markets:  Opportunities and Challenges

                     (Debapriya Dutta, PhD, Counselor S&T, Indian Embassy, Washington DC + Yaun Lin,

                     PhD, Marco Polo, Inc.)

 

                              (Recording of sessions above)

 

10:30-10:45 AM     Break

 

10:45-11:15 AM     Innovative Regulatory Pathways

                     (Edward Tabor, MD, Vice-President, Quintiles)

 

11:15-12:15 PM     Study Design Challenges and Solutions

           (Larry Tamarkin,PhD, CEO, CytImmune, Inc + Ashok Srivastava MD, Senior VP,

           Diverse Lynx)

 

                              (Recordings to sessions above)

 

12:15-1:15 PM       Lunch

 

1:15-1:30               Getting a Clinical Trial Initiated in India; A Sponsor’s Perspective

                    (Rita Khanna, PhD, JD, General Counsel, Aeras Global TB Vaccine Foundation)

 

1:30-2:15               How to Get Clinical Trial Approval in India

                    (Mukesh Kumar, PhD RAC, Senior Director, Amarex + A B Ramteke, Deputy DCGI,

                    India)

 

2:15-3:00              Recent Changes in the Indian Regulatory Processes

                   (Shoibal Mukherjee, MD DM, Senior VP, GVK Bio, India)

 

                             (Recordings of sessions above)

 

3:00-3:15              Break

 

3:15-4:00              Ethical standards for global clinical trials – An IRB’s perspective

                   (Felix Khin-Maung-Gyi, PharmD, MBA RAC, CEO Chesapeake IRB) 

 

4:00-5:00              Roundtable Discussion – Quality Issues Impacting FDA Submissions

                   (Edward Tabor, MD, Quintiles + Larry Tamarkin,PhD, CEO, CytImmune, Inc., Moderated

                   by Mukesh)

 

5:00-5:30              Wrap-Up

 

5:30-7:30              Reception

 

Day 2, April 30, 2010

 

 

8:00-9:00              Continental Breakfast

 

9:00-9:45              Regulatory Trends in Global Trials: Major Issues with Non-US Clinical Data 

                   (Ekopimo Okon Ibia, MD, Director of US Regulatory Policy, Merck & Co.) This presentation

                  will be available at a later time, please checkback again.

 

9:45-10:30            Preparing for an FDA GCP Audit

                   (Mukesh Kumar, PhD RAC + Jan Pierre, MPH)

 

                             (Recordings of sessions above) This recordiing will be available at a later time, please checkback

                                                                                  again

 

10:30-10:45          Break

 

10:45-11:30          Roundtable Discussion – Regulatory Standards for Quality Clinical Trials 

                                (Ashok Srivastava MD, Senior VP, Diverse Lynx , Ekopimo Okon Ibia, MD, Director of US

                                Regulatory Policy, Merck & Co. Panel moderated by Jan Pierre, MPH)

 

11:30-12:00          Wrap-Up: Checklist for Planning, Executing and Managing Clinical Trials in India

                   (Mukesh Kumar, PhD RAC, Amarex, LLC, Munish Mehra, PhD, CEO, Global Drug  

                   Development Experts, Inc)

 

                   (Recordings of sessions above)