GCP review and quiz

Speaker Profile

Dr Umakanta Sahoo an MBA, PhD is currently working for a clinical research organisation, Chiltern International, as general manager, heading the CRO business in India. He has an experience of over 12 years in Indian industry in various managerial capabilities, of which, over seven years in CROs as clinical research associate, clinical team leader, project manager and general manager to handle projects of global US & European pharma companies in Oncology, Neurology and Infectious Disease.

Dr Sahoo has been trained by international CROs on GCP, project management, CRA Skills, AE reporting, handling drug supplies, CRA mentoring etc. He was also the visiting faculty for Academy of Clinical Excellence (ACE), Bombay College of Pharmacy.

Synopsis

Clinical research is perceived to be a very promising business for the Indian economy with the advantage of a huge treatment population, a well-oiled regulatory system and constantly developing infrastructure. To support this emerging business, there are a number of key events being organised allowing pharmaceutical companies, CROs, investigators, regulators, academic institutions and even media to come together and share knowledge and expertise. Pharma Confluence is one of such events being organised by Express Pharma Pulse at the Bandra Kurla Commercial Complex in Mumbai between February 24-27, 2005.

The course has been specifically designed for experienced professionals, who are pursuing a career as monitors, clinical research associates, medical monitors, clinical data coordinators, project managers, etc. in pharmaceutical companies, contract research organisations (CRO) and site management organisations (SMO).

Non-adherence to Good Clinical Practice (GCP), protocol, SOP and regulatory requirements during the conduct of a clinical trial results in delays in study timelines, increase in costs of the drug development and affects patient safety.

Monitoring clinical trials to comply with GCP is vitally important to meet regulatory requirements and required SOPs. This module will cover all the key aspects of monitoring a clinical trial to GCP and the Clinical Trial guidelines. This will also include planning and preparation for setting up clinical trials, understanding the responsibilities of different stake holders at both the study site and the sponsor site, and how to carry out the crucial study site visits (including site selection, site initiation, routine monitoring and study close out).

This also describes in detail how the monitor prepares for an audit and/or regulatory inspection including an overview of common audit and regulatory findings. How the monitor can manage the challenges of technological advances on collecting data such as EDC will also be discussed.

The other topics covered in detail are the monitoring process ie. source data verification, monitoring problem and query resolutions, and detect and manage frauds. The key monitoring areas covered in the chapters are on consent process, Ethics Committee proceedings, drug accountability, adverse event reporting, patient recruitment and retention and managing clinical trial budgets, etc.

Throughout this module, interactive exercises and case studies will enhance the overall learning experience of the participants. The course will help the attendees a lot in terms of getting practical tips in clinical trial monitoring and pursuing a meaningful clinical research career in India, the future hub of clinical trial.