Chapter meeting on Saturday 18th August 2012 at 9 am, the TRC Auditorium(3rd flr)

It gives me great pleasure to invite you to the next meeting of the Tamil Nadu Chapter of the DIA wherein we focus on Regulatory Affairs. This meeting will serve as an interphase between regulators, academia and the pharma industry. I urge all your post graduate students and research / PhD scholars to enroll for this seminar and learn directly from the Regulators of international and national repute, as well as, from the leaders in the Pharma Industry and interact with them during the discussions which follow every session.

AGENDA 0800-0900 0900- 0930 Registration Inauguration

09300-1300 Session 1

0930 1030 Global Perspectives in Regulatory Affairs -'Drug approvals and the FDA Dr. A .D'sa 1030 1115 Indian Perspectives in Regulatory Affairs - Mr P.B.N. Prasad ( DDC South Zone ) o Tea break 11.15- 11.30

1130- 1220 Regulatory trends in emerging markets Dr Ezhilarasan 1220 1300 Panel Discussion

Lunch 1300- 1400

1400- 1700 Session 2

1400- 1445 Overview of IND & NDA requirements 1445- 1515 Overview of CTD and eCTD Dr Arun

Tea Break 1515- 1530

1530 1600 Audits and Inspections Dr Sudakeran C. 1600- 1630 Discussions and Question Answer session - Regulators and Speakers

SUBSCRIPTION - Rs 500

REGISTRATION -Rs 250

Chapter in charge

Dr Annabelle Rajaseharan M.D., M.B.A., 9444066519; 9840636699; anne3654@hotmail.com