Drug Regulation

SpicyIP Event: Global Pharma Regulatory Summit India 2012, Mumbai

This event comes specially 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. Please don’t forget to mention that you came via SpicyIP.

Event Name: Global Pharma Regulatory Summit India 2012

Dates: 28 Feb – 2 March 2012 [individually bookable days]

Venue: Holiday Inn Mumbai International Airport, Mumbai, India

URL: www.pharmaregulation-india.com

Contact Person: Ms Asan Bano

Contact Number: +91 (022) 4046 1466

Contact Email: [email protected]

India tops US $11 billion global generics export list

Global regulatory compliance is by far the biggest factor related to success, as pharmaceutical companies look to exploit the increasing demand of Indian generics in key export markets.

Join 120+ heads, executives, managers and team leaders of Regulatory Affairs, Quality Assurance, Quality Control and more at the Pharma Regulatory business conference and learn implementable strategies to support efficient approvals of your Indian generics in key export hot-spots.

Book for the day of your choice by registering online, or contacting Ms Asan Bano on +91 (022) 4046 1466 or [email protected] today!

Special offer for SPICY IP readers!

Our early bird discount packages that expired on 3 Feb, is now open only to SPICY IP subscribers!

Don’t miss – register quoting “SPICYIP” & take advantage of our special discounts valid until 24 Feb!

Region focused agenda:

(a) 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

(b) 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

(c) 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

To register and benefit from early bird discounts, please contact Ms Asan Bano on +91 (022) 4046 1466 or email [email protected] today!

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