Saturday, December 18, 2010

Two-Day Workshop on Practical GCP for Successful BA/BE Studies

Two-Day Workshop on Practical GCP for Successful BA/BE Studies

Dates: 7-8 January 2011
Location: Hotel Four Points by Sheraton, Vashi, Navi Mumbai

By
Arkus Clinical Trial Support Solutions, Ahmedabad &
PharMantra Consulting Services, Hyderabad

Trainers :- Dr. Anupama Ramkumar, M.D.
Ranjani Nellore, Ph.D., RAC

Cost of the program: Rs. 9250/-
(Inclusive of course material, lunch and refreshments)

Who would benefit?
All clinical research professionals in BA/BE studies in sponsor and CRO companies, principal investigators, monitors & auditors responsible for GCP compliance. This workshop will provide invaluable insight into practical aspects of BA/BE studies, with respect to GCP applications and systems to ensure execution of regulatory compliant studies and exceed customer expectations.

About the trainers:
Dr Anupama Ramkumar, M.D (Med) is a well known GCP trainer & consultant in India and runs Arkus Clinical Trial Support Solutions, a rapidly growing, training and consulting firm engaged in assisting sponsor companies running their trials in India, auditing and monitoring CROs/sites and other vendors for optimal trial conduct and logistics. She has been a part of the clinical research Industry in India since its early days and has herself been an Investigator on Phase 1 trials while working as the Medical Director at Lambda Therapeutic Research, Ahmedabad,India.

Ranjani Nellore, Ph.D. RAC is a regulatory affairs certified professional with over 12 years of pharmaceutical industry experience in USA and India. She has submitted clinical trial applications and INDs to FDA, MHRA, TPD (Canada) and DCGI for several NCEs. She has participated in meetings with the EMEA and USFDA. She is an invited speaker at national and international meetings and renders customized training programs. She has now established PharMantra Consulting Services which provides regulatory consulting services to the global health science industry.

If bioequivalence is part of your business, Don’t miss this workshop!!
To register, please send email to:Anupama@arkusresearch.com ; ranjani@pharmantra.com or

Call Dr. Anupama at 98254 13761 or Dr. Ranjani at 99590 72225