Global Pharma Regulatory Summit India 2012 (Global Pharma Regula)

Venue: Mumbai

Location: Mumbai, Maharashtra, India

Event Date/Time: Feb 28, 2012 End Date/Time: Mar 02, 2012
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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.

With increasing competition and complexities involved in complying with rapidly evolving regulatory protocols, companies are seeking hands-on insights into effective execution of stringent regulatory guidelines to ensure early entry and a smooth approval process in both highly mature and emerging markets.

Join 100+ industry leaders at this business-critical summit and learn implementable strategies to support efficient approvals of your Indian generics in key export hot-spots.

Regional Focus Days

Each day is focused on a different region – allowing you to choose the areas of most relevance to your business:

US – 29 February 2012; EU – 1 March 2012; India and ROW – 2 March 2012

Attend the days of your choice to get in-depth insights into:

• Global regulatory regimes and developments

• Most recent regulatory updates and ever-changing regulations in key export markets

• Effective query handling strategies for DMF and generic applications filing in both regulated and semi-regulated countries

• Pharmacovigilance compliance in key markets

• Clarifying requirements for hybrid and 505(b)(2) applications in EU and US

Plus! Introduction to Global Regulations Workshop - 28 February 2012

A must-attend interactive workshop for new entrants or companies planning to enter into regulated markets focusing on the basic regulatory protocols and critical documentation needs that will lead to successful and swift approvals of your generic products

New for 2012!

- Extended Query Handling Sessions – Come armed with your most challenging questions and leave with a toolkit of practically implementable solutions pertaining to effective deficiency handling in both regulated and emerging markets

- Interactive Regulatory Awareness Programme – A must attend workshop for new entrants with structured presentations, break out sessions and frequent Q&A to help you get to grips with the basic regulatory requirements in the US and EU markets

- Speed networking – Meet a wide variety of people in quick succession and strike-up profitable relationships…. bring plenty of business cards!

To register and for further information, please contact Ms Asan Bano at +91 (022) 4046 1466 or email