An international workshop on 'Compliance in New and Generic Clinical Drug Development' is being organized jointly by Indian Pharmaceutical Association - Industrial Pharmacy Division and US based Transworld Institute of Professional Development & Training on July 28 and 29, 2006 at Hyderabad.
Dr P Khadgapathi, president, Indian Pharmaceutical Association - Industrial Pharmacy Division informed that IPA - Industrial Pharmacy Division informed this International Workshop will provide an overview of different issues in clinical trial compliance during the development of new and generic drugs.
The workshop will cover the national and international regulatory framework for clinical compliance, ethics of human subject research, compliance issues from different stakeholders in clinical trials. Additionally, the mechanics of trial conducted and pre- and post- trial activities will be discussed. Role of important documents such as informed consent, study protocol and study records will be highlighted. Importance of statistics in trial design will be discussed. One of the key objectives of this workshop is to discuss the important issues that sponsor auditors look into before contracting out the trials.
Dr B Prabha Shankar, president, Transworld Group and secretary, Indian Pharmaceutical Association - Industrial Pharmacy Division informed that Transworld had organized its first international workshop on," Fundamentals of Clinical Trials & Good Clinical Practice in India last year. This year, a two-day workshop has been specially designed for those professionals who are likely to make their career in Clinical Research ( Clinical Trials & BE/BA Studies ) and also for those Doctors, Pharmacists and Scientists working in Hospitals, Pharma Companies and Clinical Research Organizations who are involved as Project Managers, Clinical Research Associates and Clinical data Co-ordinators. Also it is intended for sponsors of clinical research institutions, members of institutional review board or ethical committee.
The workshop would lead to understanding of - the general stages of new drug development from discovery to regulatory approval, key regulations and guideline governing clinical research, importance of ethics and confidentiality in clinical research, importance of GCP and SOP in clinical trials, importance of accredited clinical trial sites and IRBs. It will also help in knowing how to write an SOP and what to expect in audits, design Bioequivalent studies, in vitro in vivo correlation and its implication in generic drug development. There will be interactive sessions during the course of the workshop, which will enable the delegates to learn, understand and gain in depth knowledge about the SOP.
Dr Bhaskara R Jasti, vice president of Transworld group and professor of Pharmaceutics, University of the Pacific, Stockton, CA, USA informed that Transworld is bringing internationally recognized and experienced speakers to offer high quality of presentations on the above topics which are of great interest to the Indian CROs.
Dr Raj Pradhan, Abbott Laboratories, USA, would be addressing the delegates on Preclinical and Clinical Studies in New Drug Development Overview, Regulation of New Drug Development in US/EU/Japan with emphasis on FDA Approval and Monitoring (Audit) Process & EMEA and PMDA, Overview of Generic Drug Approval Process and Regulatory Process of Approving Generic Drugs
Dr Charles Pierce, president, Global Clinical Partners, Inc. USA, will train the delegates in the areas of Protecting Human Subjects in Clinical Research, covering issues like responsibilities of the PI, IEC/IRB, Sponsor, CRO; Protocol and Investigator Brochure, ethics of Human Subject Research and Informed Consent Process.
Dr Carolyln E. Rugloski, i3 statprobe, USA will address the delegates on the topic, "Standard Operating Procedures: Ensuring Good Clinical Practice (GCP) through SOPs ". The Bioequivalence Concept, Design and Analysis of Bioequivalence Study will be discussed by Dr Balakrishna Hosmane, Northern Illinois University, USA. The role of IVIVC (In-Vitro In-Vivo Correlation) and BCS (Biopharmaceutics classification) in Generic Drug Development will also be discussed, in the workshop.