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SELECTBIO Conferences Generics - Expanding the Base: Improving Business and Regulatory Predictability for Complex, Niche Generics

Generics - Expanding the Base: Improving Business and Regulatory Predictability for Complex, Niche Generics Agenda



Co-Located Conference Agendas

QbD in Pharma Development 2014 | 


Other Track Agendas

Biologics - Quality Biologics for Ensuring Regulatory and Market Sucess | Generics - Expanding the Base: Improving Business and Regulatory Predictability for Complex, Niche Generics | 

Print Agenda

Monday, 24 February 2014

08:00

Registration


Round Table Discussion -Pharmaceutical Equivalence - What do we need to consider - Moderator : Dr Ajaz Hussain

09:00

Pharmaceutical Equivalence - What do we need to consider
Ajaz Hussain, Consultant, Insight Advice & Solutions LLC, United States of America

09:01

Pharmaceutical Equivalence - What do we need to consider
Vipan Dhall, Vice President & Head, Piramal Pharmaceutical Development Services Pvt Ltd, India

09:03

Pharmaceutical Equivalence - What do we need to consider
Venkateswarlu Vobalaboina, Managing Director, Neuheit Pharma Technologies Pvt Ltd, India


Plenary Talk

09:30

Ajaz HussainKeynote Presentation

Challenges & Advancements in Complex Generics Formulations
Ajaz Hussain, Consultant, Insight Advice & Solutions LLC, United States of America

10:10

Tea Break and Networking in Exhibition Area


Session 1 - Complex Generic Formulations

10:30

Current trends,Challenges and Role of Partnering in Development of Complex Generic Formulations for India and Emerging Markets
Harvinder Popli, Managing Director, Zandria Farmaceutica Pvt Ltd, India

11:00

Complex Generics- Pricing Pressures & Cost Reduction Strategies for India Drug Industry
Venkateswarlu Vobalaboina, Managing Director, Neuheit Pharma Technologies Pvt Ltd, India

11:30

Generic ANDA Filing in eCTD Format
Rajashri Ojha, Founder & Director, Raaj Global Pharma Regulatory Affairs Consultants, India


Session 2 - New Markets and Opportunities for Generics

12:00

Exploring New Destination for Generics - Japan Pharmaceutical Market
Praveen Khullar, Senior Director, Sanofi Aventis Group, India

12:30

Contract Research and Manufacturing-Generics & NCE's
Anurag Hitkari, Principal Advisor/Vice President, PragMetis Pharmaserve LLP, India

13:00

Lunch Break and Networking in Exhibition Area


Session 3 - Innovation: Route for Generics Pharma Industry's Success

14:00

Innovation: Route for Generic Pharma Industry's Success
Rajeev Raghuvanshi, Vice President, Dr Reddy's Laboratories Ltd, India

14:30

Accelerated Growth through Innovation
Ashish Gogia, Vice President, Cadila Pharmaceuticals Limited, India

15:00

Patenting Complex Generic Products
Mandar Shah, Vice President, Promed Group Ltd., United States of America

15:30

Tea Break and Networking in Exhibition Area

15:50

From Biostudies to Biowaivers using IVIVC
Bhupinder Singh Bhoop, Dean, UIPS, Panjab University, India


Round Table Discussion - Improving Regulatory Predictability for Generics Registration - Moderator : Dr Subir Basak

16:30

Improving Regulatory Predictability for Generics Registration
Subir Basak, President, Jubilant Life Sciences Limited, India

16:31

Improving Regulatory Predictability for Generics Registration
Anthony Crasto, Principal Scientist, Glenmark Generics Limited, India

16:32

Improving Regulatory Predictability for Generics Registration
Rajashri Ojha, Founder & Director, Raaj Global Pharma Regulatory Affairs Consultants, India


Add to Calendar ▼2014-02-24 00:00:002014-02-24 00:00:00Europe/LondonGenerics - Expanding the Base: Improving Business and Regulatory Predictability for Complex, Niche GenericsSELECTBIOenquiries@selectbiosciences.com