Arkus Clinical Trial Support Solutions, Ahmedabad in association with
PharMantra Consulting Services, Hyderabad, is organising a two-day workshop on ‘Practical GCP for successful BA/BE Studies’ on January 7 and 8 at Sheraton, Vashi, Navi Mumbai.
The workshop is focused on practical applications of GCP in BA/BE studies. It will discuss on the “must have” systems for BA/ BE studies (to ensure regulatory compliance), the “good to have” systems for increased productivity and client acceptability and the “nice to have” systems for standing out in the crowd as a service provider.
The event is intended for clinical research professionals in BA/BE studies, CROs, principal investigators, monitors & auditors responsible for GCP compliance. It may provide an insight into practical aspects of BA/BE studies, with respect to GCP applications and systems to ensure execution of regulatory compliant studies.
Dr Anupama Ramkumar, MD and Ranjani Nellore, PhD, RAC will be the trainers in the workshop. Dr Anupama Ramkumar, MD (Med) is a well known GCP trainer & consultant in India and runs Arkus Clinical Trial Support Solutions, a training and consulting firm engaged in assisting sponsor companies running 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 I trials.
Ranjani Nellore, PhD 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.