Indian pharma companies have a large chunk of their revenues coming from exports. With some focusing on the generics market in the US, Europe and semi-regulated markets, others are turning their attention to custom manufacturing for innovator companies.

The only factor coming in between is from the regulatory authorities . The USFDA's warning letters and import alerts, if issued, are a huge setback to companies. These issues have come to light only in the last decade when India's exports to US were ramped up. More than eleven Indian drug makers have been issued such warning letters so far this year by the FDA, which has also ordered recall of certain drugs manufactured in India. Domestic companies need to learn and gain experience in handling USFDA issues so that they avoid the misses.

Keeping this in mind CPhI India brings you the 4th Edition of Global Pharma Regulatory Summit scheduled on 22-23-24 April in Mumbai, focusing on the clarification and solution to the most critical regulatory issues faced by the Indian Pharma companies. This three day strategic summit provides insights on the US, Europe, Indian and ROW region which are constitute to the major revenue of any Indian Pharma company.

Countries taking part at GPRS

Whats New in 2015?
  • Quality Based Review CMC Evaluations of ANDAs
  • Expectation of USFDA towards ICH M7- Genotoxic impurities
  • Bioequivalence requirement for modified released formulations
  • Quality by Design through statistical, analytical and risk-management methodology in the design, development and manufacturing of medicines and PAT perspective
  • Harmonisation of guidelines – ROW

Who should attend?
  • Regulatory Head
  • Regulatory Managers
  • Regulatory Executives

conference website