Tools for Compliance – SOPs Guide to defining need, development and maintenance of SOPs
&
Regulatory Inspections : Preparing for and meeting expectations
17 - 18 July 2009 at The Residence Hotel & Convention Centre & Ramada, Powai, 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. 5500/-per workshop
(Inclusive of course material, lunch and refreshments; discounts available for groups and individuals who register for both workshops)
Who would benefit – Clinical research professionals in sponsor, CRO, SMO companies, principal investigators and site staff engaged in activities requiring compliance with regulatory and GCP requirements.
About the trainers:
Dr Anupama Ramkumar, M.D (Med) is a well known GCP Trainer 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, helping identify/audit 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 US FDA. 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.
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
