Seminar on GCP ends on a high note
EPP News Bureau – Bangalore
WITH a motive of achieving pharmaceutical excellence, Express Pharma Pulse, had organised a seminar cum workshop on Good Clinical Practice (GCP). The two-day workshop discussed the evolution of GCP, its needs and current trends in GCP. It received an overwhelming response from as many as 70 participants representing academic institutions, pharmacy colleges, medical colleges and industry across the country.
The faculty comprised of Dr P Satishchandra, NIMHANS, Bangalore; Dr Prem Pais of St John’s Medical College, Bangalore; Jeroze Dalal, AstraZeneca, Bangalore; Dr Akash Ganju of Pfizer India; Sanjay Sane, Novartis, Mumbai and Dr Chetan Tamhankar, SIRO, Mumbai who enlightened the participants on various issues from development to regulatory skills required to adhere to GCP.
Dr K Nagarajan, a distinguished scientist based in Bangalore, the chief guest on the occasion, educated the participants on the path to new drug discovery and development. He also opined that pharma research outsourcing is the key for getting drugs to market faster. ‘‘Factors like reduced time of development, incomplete awareness of regulatory affairs in a foreign country, large requirement of patient population have stressed on the need for outsourcing clinical research,’’ he added.
Dr Arun Bhatt, consultant in pharmaceutical medicine and clinical pharmacology, Mumbai, was the co-ordinator of the event who briefed the participants on the evolution and needs of GCP. He expressed his views on the process of informed consent. Later in the day, he also dealt with administrative issues in clinical trials like drug supply, publication and finance.
Dr Akash Ganju from Pfizer India, spoke on the sponsor’s responsibilities and on identifying investigators and investigator qualifications. Speaking on Adverse Event Reporting (AER) and guidance for hospitalisations, Sanjay Sane, manager, Clinical Development and Drug Safety, Novartis, said minimum information is required for Serious Adverse Effect (SAE) report and typical quality problems. He also said that AER is the joint responsibility of sponsor and investigator.
Dr Prem Pais, Department of Medicine and Epidemiology, St John’s Medical College, Bangalore presented a paper on the role of ethics committee in GCP trial and the ethical principals of clinical research. He also stressed on the responsibilities of the Institutional Review Board (IRB) and on the importance of records keeping and documentation. Laying emphasis on Investigator meeting Jeroze Dalal, manager, Clinical Operations, AstraZeneca Pharma India, said investigator meeting is a critical component of clinical trial preparation process. ‘‘It provides a platform for airing concerns that various sites may share and helps to reach common solutions,’’ she opined.
Quality assurance and audit, another key issue in GCP was discussed by Dr Chetan Tamhankar, general manager, SIRO Clinpharm, Mumbai. “Ethical obligations, confidentiality with transparency and quality are the three things that have to be kept in mind,” he said. “As clinical research professionals, we all are bound to be audited and scrutinised and checked upon. Auditing is a positive activity and a positive learning tool” he asserted.
“The purpose of audit is to determine whether the rights and safety of the subjects have been adequately protected and ensure validity of data and integrity of clinical study. It also reviews the sponsor and investigator activities,” Dr Chetan remarked.
Sharing her thoughts with the august gathering, Dr Kala Suhas Kulkarni, Medical Advisor at The Himalaya Drug Company in Bangalore, said “Today India has become the prime location for clinical trials. We need to upgrade research with more and more guidelines.” Pointing out that India lacks multi centric studies, Dr Kulkarni said industry and academia has to work closely. There is also a need to identify few key areas for herbal drug research and we need go into comparison of natural and allopathic form of drugs” she added.