Putting Science to Work

Viral Safety Workshop

Venue: The Oterra Hotel, Electronic City Phase 1, Bengaluru, India.   Date: 12th July 2019

Overview of the Workshop

The workshop will touch upon various aspects of virus safety- regulatory expectations for viral clearance study (VCS), considerations while conducting VCS, study design for VCS, case studies on novel and biosimilar viral clearance studies and viral clearance technologies prevalent in biopharma industry etc.

Highlights of the Workshop
  • Chance to hear from Industry experts in the field of Viral Safety
  • Participants from Indian Biopharma Industry get to meet, interact and share experiences on Viral Safety
  • Opportunity for participants to see the Syngene’s capability on Viral Testing
  • Active participation in round table sessions
  • Query quenching sessions for participants to ask panel of experts in your areas of challenges
Key Speakers

  • Joke Ederveen, Senior Consultant, Edra Services, The Netherlands 
    (Topic - Exemplary stories revealing expectations and practises within the current global regulatory landscape of Viral Safety)
  • Sherri Dolan, Global Technology Consultant, Virus Clearance, Sartorius 
    (Topic - Viral Clearance Strategies Utilizing Orthogonal Technologies)
  • Rahul Fadnis, Site Head, Viral Testing Facility, Syngene International Ltd 
    (Topic - Viral Safety of Biopharma products - Syngene's Role)
  • Hazel Arahna, SME, Viral Clearance and Safety, Sartorius 
    (Topic - Regulatory Perspective and Risk Management for Virus Safety Assurance of Biopharmaceuticals)
  • Jyoti Iyer, General Manager, Biocon Research Limited 
    ( Topic - Viral clearance Case studies for biosimilar and novel mAbs,)
  • Indraneel Sanyal, Process Development Head, Syngene International 
    (Topic - Designing Purification strategies of Low pI mAbs for Virus Clearance)
  • Ravinder Dabas, Business Head - Bioprocess, Asahi Kasei 
    (Topic - Viral clearance study for Virus filtration)
  • Hee Woo Park, Director, Scientific Laboratory Services – APAC, Pall Biotech
    (Topic - Virus Filtration in Continuous Bioprocessing)

Learning Objectives
  • Enhance knowledge and awareness on Viral Safety
  • Understand the viral risk and ways of mitigation
  • Understanding the regulatory expectations from industry experts
  • Making industry aware of Syngene’s capabilities on Viral Clearance
  • Knowhow of Viral Safety and regulations available
  • Gaining insights of attaining viral safety through case studies and anecdotes from industry experts
  • Understanding the Viral Clearance technologies and how industry utilizes them to meet regulatory requirements
  • Designing VCS and considerations
  • Click here to download the Workshop details.

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