National Workshop on Pre-clinical and Clinical Research exclusively for Siddha Professionals during 3-4th November 2009
In an era of increasing international popularity for Traditional Systems of Medicine and the evolution of the concept of Integrated System of Medicine as an accepted practice in patient management, there is an urgent need for Indian systems of Medicine to adopt Evidence Based Medicine concepts for international acceptance. As Siddha Medicine is being approached largely, there is an urgent need for Siddha Professionals to know-how of modern preclinical and clinical research. In this direction, National Institute of Siddha, Central Research Institute for Siddha (presently renamed as Siddha Central Research Institute) and Sri Ramachandra University with support of Department of AYUSH, Ministry of Health and Family Welfare, Govt. of India, conducted a “National Workshop on Pre-clinical and Clinical Research” exclusively for Siddha Professionals during 3-4th November, 2009 at Sri Ramachandra University, Chennai. Hon’ble Thiru.S Gandhiselvan, Union Minister of State for Health & Family Welfare, Govt. of India inaugurated the Workshop in presence of Shri.B.Anand, Joint Secretary, Dept. of AYUSH, Shri.G.A.Raj Kumar, Principal Secretary & Director, Dept. of Indian Medicine & Homoeopathy, T.N.Govt., Shri. V. R. Venkataachalam, Chancellor, SRU, Prof.Dr. K. Manickavasakam, Director I/C – NIS, Dr. S. Thanikachalam, Chairman – Workshop, Dr.T.Anandan, Asst. Director, CRI – Siddha. Hon’ble Minister mentioned in his inaugural address that while the value of traditional siddha was recognized by Western societies, the lack of scientific validation of its efficacy stood in the way of a more widespread acceptance. Thus, Siddha professionals needed to be exposed to the technical know-how of modern pre-clinical and clinical research.
The following topics covered in the workshop
- Good manufacturing practice and quality control of Siddha Medicines – Regulatory aspects
- Need for conducting regulatory toxicology in GLP facilities
- Importance of ethics in pre-clinical research
- Designing a Pre-clinical study
- Interfacing Pre-clinical and Clinical research
- Regulations governing clinical research in India
- History of GCP/ICH & Principles of GCP
- Informed Consent Process & Overview of safety reporting
- Study design and Clinical Trial Protocol
- Essential documents for conducting a clinical trial
This workshop has underscored the importance of adhering the concepts of GMP, GCP, pre-clinical and clinical regulatory issues in drug validation. A total of 250 Siddha professionals had participated and benefited by this two days workshop.