The Algorics team were delighted to be involved in last week’s Indian Cancer Congress.  Our VP Clinical Solutions, Abby Abraham, participated in the lively panel discussion ‘ICH GCP (R2): Its impact on how trials will be run’ with industry experts from CDSCO, IQVIA, Navitas, Nextvel Consulting LLP, Qmatra and BIOCAD.  The panel were pleased for the opportunity to engage with the attending Joint Drugs Controller General of India. Abby sums up the discussions for us below:

 

  • India’s regulatory framework is becoming conducive to conducting clinical research.  We discussed the importance of ICH-E6 (R2) and its global impact on evolving Indian regulations.
  • We had open minded and collaborative discussions between the various clinical research stakeholders and the role of India to drive the new model.
  • Pragmatic views were shared by the regulatory authority on ICH-E6 (R2) addendum.
  • There was acceptance in the panel that technologies that worked in the past cannot holistically enable new process requirements.

 

Thank you to all those that attended the session in-person and helped to create an interactive and informative session for all those involved.