The Arkus Clinical Trial Support Solutions, Ahmedabad and PharMantra Consulting Services, Hyderabad are organizing a one-day workshop on 'GCP 2010: FAQs Exploring common GCP Myths and Misconceptions' on November 30 in Hyderabad.
This highly interactive workshop is an essential GCP (good clinical practice) refresher and problem solver for all clinical research professionals striving for GCP compliance amidst multiple priorities. It will be a good opportunity to understand where the research professionals commonly misinterpret GCP requirements and add more chaos to the already existing dichotomies. It will also be useful to learn to separate the facts and true expectations of GCP compliance in clinical research in order to become more effective.
Clinical research professionals in sponsor, CRO, SMO companies, principal investigators and site staff can attend the programme to understand more about the GCP. It will be a good platform to learn,explore and discuss common pitfalls of GCP application, common regulatory requirements(form 1572 for instance) and areas where the investigators/monitors/auditors need to watch out for. Dr Anupama Ramkumar MD and Ranjani Nellore, RAC are the trainers of the workshop.
The workshop is significant because in spite of mandatory GCP training offered by organizations prior to getting employees started on the job, misinterpretations, misunderstandings and mis-applications of GCP abound in real life. "During our many CRO and site audits we have sometimes been dismayed at discovering how a lot of unnecessary work and documents are generated in the name of GCP!! From duplication of ICF at sites and measuring leftover food for each subject meal in BE studies,we know we haven't yet seen all. This day-long advanced workshop is a step in the direction of sorting out these common and unusual confusions caused by only theoretical understanding of GCP," said Ranjani Vellore.
Dr Anupama Ramkumar, MD (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.
Ranjani Nellore, 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.