Drug Regulation

SpicyIP Event: Global Pharma Regulatory Summit India 2012, Mumbai


This is a gentle reminder for those of you interested in pharma regulation, from the same folks who organised the Pharma IPR Summit recently. The organisers send us the following details. You can also click through on the banner on the left for further details.

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Event Name: Global Pharma Regulatory Summit India 2012

Dates: 28 Feb – 2 March 2012 [individually bookable days]
Venue: Holiday Inn Mumbai International AirporMumbai, India
URL: www.pharmaregulation-india.com
Contact Person: Ms Asan Bano
Contact Number: +91 (022) 4046 1466
Contact Email: [email protected]

Over 150+ attendees have registered for the Pharma Regulatory business conference (28 Feb-2 March), taking place at the Holiday Inn Mumbai International Airport, Mumbai, India!

With only 10 seats remaining, I wanted to ensure you and your team don’t miss out on this comprehensive programme, designed specifically for you as you look to overcome global regulatory complexities, ensure early market entry and drive generics exports worldwide.

Register today!
Register online, or contact us on +91 (022) 4046 1466 or [email protected] today! Visit www.pharmaregulation-india.com for further details.
Region focused agenda:

  1. 29 Feb: US regulations – Learn practical insights to ensure flawless submissions for:
  • DMF and ANDA filing procedures
  • CTD and ECTD submissions
  • Variation handling process
  • Critical pharmacovigilance requirements
  • Approval of 505 (b)(2) applications
  • Dosage based deficiencies
  1. 1 March: EU regulations – Gain in-depth insights through live examples and comprehensive query handling sessions on:
  • Stability and impurity profiling requirements
  • Generic drug application filing procedure
  • Post approval supplements
  • Variation guidelines
  • Requirements for hybrid applications in the EU
  1. 2 March: India, Japan and ROW regulations – Understand and overcome complexities involved in gaining swift regulatory approvals for DMF and generic applications in:
  • India
  • Japan
  • Latin America
  • Australia
  • Russia
  • China
  • South Africa

  1. Plus! 28 Feb: If you are a new entrant to the market, you cannot miss our Pharma Regulatory Awareness Workshop – benefit from in-depth understanding of the comprehensive regulatory procedure for filing DMF and generic applications in regulated markets


To register contact Ms Asan Bano on +91 (022) 4046 1466 or email [email protected] today!

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