The Indian chapter of Parenteral Drug Association (PDA), which was recently set up in Mumbai, is organizing a two-day workshop on Common Technical Document (CTD) for the benefit of the industry. The CTD workshop is being conducted in the country for the first time.

The event, which would take place at Hyderabad on October 18 and 19, 2004 at Hyderabad, is the first of its kind in India and South East Asia, being organized by PDA. The workshop aims at providing hands-on training on how to structure and compile a CTD, besides how to file variations for specific situations and getting prepared for EMEA / CHMP inspections.

At the workshop, Dr Usfeya Muazzam, senior reviewer, German Federal Institute for Drugs and Medical Devices, Germany is to impart training. According to PDA sources, the workshop would be useful to professionals in quality assurance, quality control, regulatory affairs and those who compile, write, review or assess marketing authorization application of their companies.

PDA is a non-profit international association with more than 10,000 scientists involved in the development, manufacture, quality control and regulation of pharmaceuticals, biopharmaceuticals and related products.

Dr Darshan Makhey, vice-president, Corporate Regulatory Affairs and Drug Development, Nicholas Piramal India, has been chosen as the president for PDA India Chapter.