08:00 | Registration |
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Round Table Discussion - Looking Forward with Confidence to Regulatory and Commercial Success - Moderator : Dr. Ajaz Hussain |
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09:30 | Looking Forward with Confidence to Regulatory and Commercial Success
Ajaz Hussain, Consultant, Insight Advice & Solutions LLC, United States of America
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09:31 | Looking Forward with Confidence to Regulatory and Commercial Success
Anthony Crasto, Principal Scientist, Glenmark Generics Limited, India
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09:32 | Looking Forward with Confidence to Regulatory and Commercial Success
Bharata Parayitam, Biotechnology Professional, Dr. Reddy’s Laboratories Ltd, India
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10:10 | Tea Break and Networking in Exhibition Area |
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Plenary Talk |
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10:30 |  | Keynote Presentation Emerging Opportunities in Bio-Therapeutics- Converting Biosimilars into Bio"Leaders"
Girish Sahni, Director, CSIR-Institute of Microbial Technology, India
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Session 1 - Development of Biologics |
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11:10 | Physical, Chemical and Biological Characterization and Similarity in Biologics
Ajaz Hussain, Consultant, Insight Advice & Solutions LLC, United States of America
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11:50 | Recommendation for Best Practices in Developing Bioanalytical Assays For Biologics Production, Preclinical and Clinical Programs
Arumugam Muruganandam, Mananging Director & Chief Scientific Officer, Affigenix Biosolutions Pvt Ltd, India
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12:20 | Taking Similar Biologics from Development to their Marketing Authorization: Technical and Regulatory challenges
Sanjay Sonar, Director, BioGenomics Limited, India
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12:50 | Discussion |
13:00 | Lunch Break and Networking in Exhibition Area |
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Session 2 - Biosimilars: Future Perspective |
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14:00 |  | Keynote Presentation Biosimilar Product Development- Challenges and Opportunities
Maharaj Sahib, Director, Wockhardt Ltd, India
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14:40 | Similar Biologics / Biosimilars : An Indian Perspective
Suresh Jadhav, Executive Director, Serum Institute of India Ltd, India
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15:10 | Tea Break and Networking in Exhibition Area |
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Session 3 - Regulatory Challenges for Biologics |
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15:30 | US FDA Guidance and Regulatory Compliance for Biosimilars
Arvind Mishra, Joint President, Cadila Pharmaceuticals Ltd, India
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16:00 | US FDA Guidance and Regulatory Compliance for Biosimilars
Shrivathsa Achar, Manager, Biocon Limited, India
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16:30 | Closing Remarks & End of the Conference |
Add to Calendar ▼2014-02-25 00:00:002014-02-25 00:00:00Europe/LondonBiologics - Quality Biologics for Ensuring Regulatory and Market SucessSELECTBIOenquiries@selectbiosciences.com
