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SELECTBIO Conferences Biologics - Quality Biologics for Ensuring Regulatory and Market Sucess

Biologics - Quality Biologics for Ensuring Regulatory and Market Sucess

Date: Tuesday, 25 February 2014
Location: Mumbai, India


Keynote Speakers

Maharaj Sahib

Maharaj Sahib
Director, Wockhardt Ltd

Girish Sahni

Girish Sahni
Director, CSIR-Institute of Microbial Technology

Overview

SELECTBIO is organizing an international event “GENERICS AND BIOLOGICS” conference and exhibition on February 24-25, 2014 in Ramada Hotel and Convention Centre, Mumbai, India.

Quality and structure of biologics is of utmost importance because of their dependency on extremely narrow specifications in manufacturing processes. This track on Biologics will focus on development of quality biologics on one hand and regulatory requirements and compliance issues as well as expedited approval and market introduction of biosimilar competitors on the other hand.  Biosimilars or follow-on-biologics or subsequent entry biologics provide potential cost saving opportunities for drug manufacturers and therefore will be in the spotlight.

This event is co-located with our 2nd international event on “QbD in Pharma Development” and an exhibition featuring latest technology and equipment in formulation development, bioanalysis and software for QbD studies. Registered delegates will have unrestricted excess to all tracks and exhibition.

Agenda Topics

  • Biosimilar mAbs in US, Europe and Emerging Economies
  • New Regulatory Requirements for Biosimilar Approval and Success in India
  • Physical, Chemical and Biological Characterization and Similarity in Biologics
  • Pre-clinical and Clinical Similarity
  • US FDA Guidance and Regulatory Compliance for Biosimilars

Sponsorship and Exhibition Opportunities

Ira Sood, Exhibition Manager
i.sood@selectbio.com
7696225050

Confirmed Speakers to date

Shrivathsa Achar, Manager, Biocon Limited
Anthony Crasto, Principal Scientist, Glenmark Generics Limited
Ajaz Hussain, Consultant, Insight Advice & Solutions LLC
Suresh Jadhav, Executive Director, Serum Institute of India Ltd
Arvind Mishra, Joint President, Cadila Pharmaceuticals Ltd
Arumugam Muruganandam, Mananging Director & Chief Scientific Officer, Affigenix Biosolutions Pvt Ltd
Bharata Parayitam, Biotechnology Professional, Dr. Reddy’s Laboratories Ltd
Sanjay Sonar, Director, BioGenomics Limited


Exhibition Sponsors Media Sponsors Networking
U-Networks

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