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

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

Co-Located Conference Agendas

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

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

09:01

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

09:03

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

Plenary Talk

09:30

Keynote Presentation

Challenges & Advancements in Complex Generics Formulations
Ajaz Hussain, Consultant, Insight Advice & Solutions LLC

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

11:00

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

11:30

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

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

12:30

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

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

14:30

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

15:00

Patenting Complex Generic Products
Mandar Shah, Vice President, Promed Group Ltd.

15:30

Tea Break and Networking in Exhibition Area

15:50

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

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

16:31

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

16:32

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