Sachin Jagdale – Mumbai
 |
| (L to R) – Dr Jitendra Dwivedi, Chairman, Trends Exports; Knud Ryhl, Medicines Inspector, Danish Medicines Agency and Bharati Kale, Deputy General Manager, Trends Exports |
Trends Exports recently organised a seminar in Mumbai for understanding regulatory aspects of EU-GMP inspection in Europe. Discussions were held on the expectations of regulatory bodies in Europe before permitting the export of pharma Active Pharmaceutical Ingredients (APIs). Trends Exports is currently involved in export of pharmaceutical APIs, as well as transfer of technology and also as consultant to pharma companies.
The seminar was conducted by Knud Ryhl, Senior Inspector, Danish Medicine Agency. Quality Assurance (QA), Quality Control (QC) and production professionals from the pharma industry attended the seminar. Knud briefed attendees over how to overcome the deficiencies which are being noted during the inspection by various European inspection agencies. Basic information of current EU Legislation, as well as what is being expected in 2013, were also discussed.
Speaking on the occasion, Dr Jitendra Dwivedi, Chairman, Trends Exports said, “I am currently advising companies on EU-GMP besides getting them inspected for EU-GMP certification. The lecture by Knud was one such initiative to educate our pharma professionals about EU-GMP requirements. This seminar was scheduled over two days and on both days there was a huge turn out. We will try to organise such seminars every alternative year at various locales.”
One of the attendees, Raghumitra, Director, Lee Pharma said, “The seminar by Knud was fruitful for API manufacturing companies. It almost covered the complete spectrum of the quality aspects of the API manufacturing units. We look forward to have such seminars in Hyderabad and expect huge footfalls.”
During the seminar, there were question answer sessions, where participants asked Knud questions pertaining to different aspects of regulation.
