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Report by RQA India Chair: Jamila Joseph

 

The first Regional Forum of the RQA in India was held on 23 Feb 2019 at the iconic Taj Mahal Palace Hotel in Mumbai in the rooftop banquet hall, Rendezvous. It was attended by 50 Quality Management professionals from all across India, including both members and non-members of RQA. The event began at 9 AM with the rendition of the National Anthem and a lighting of the lamp to symbolize auspicious beginnings.

The RQA India Chair, Jamila Joseph of Reliance Life Sciences, opened the proceedings with an introduction to RQA and explained its mission and vision, and the salient features of the Volunteer Programme. Kamaldeep Singh Grover of Vimta Labs spoke on quality standards -ISO 17025, ISO 15189 and GLP and set the stage for a session on management review, cost of quality and QbD by Amit Guru of Sparta Systems. 

This was followed by some lively debate on the topic of whether complying with the law of the land comes in the way of complying with global quality standards. Audience votes were collected before and after the debate and a clear winner emerged as the majority voted to say that global quality standards can be met regardless of the challenges posed, as long as there is a will to do so. While Ram Sundaram of Abbott Healthcare moderated the debate, both sides of the motion were represented by Anupama Ramkumar of Arkus Research, Amey Mane of Dr. Reddy's Laboratories, Harish Sankarankutty of George Clinical, and Rohan Shah of Rhizen Pharmaceuticals. 

Sandhya Ravi of Prameya Health shared her perspective on research quality as a clinician and Ethics Committee member.  During the fireside chat on data integrity, Labhu Sanghani of Jai Research Foundation highlighted the importance of calibration and site SOPs, and discussed the impact of inspection findings. Anupama Ramkumar then conducted an interactive web-enabled session to drive home several ICH E6(R2) points on data integrity. The entire audience participated using their cellphones and the results were displayed in real time for all to brainstorm on.

Jayashree Acharya of RxLogix spoke on Agile in product development for software products used in pharma, Computer Systems Validation and how to move to the cloud, while Kiran Choudhari of Reliance Industries introduced the delegates to the potential uses of blockchain and AI within healthcare. 

The Chair welcomed feedback from all delegates and emphasized that this was the start of a research quality movement for India that everybody now needs to drive through constant communication and close networking.

Each session was marked with deep sharing of experiences and plenty of Q&A. The networking breaks were very lively and the food was enjoyed by all. Individual interviews were set up by facilitator, Ananth Subramanian during the breaks to capture the aspirations and expectations of the attendees. Rashmi Bangalore of Jubilant Biosys gave away the mementos to the speakers. 

The RQA would like to thank Sparta Systems and RiverArk for their sponsorship of this event.  We hope it has laid the groundwork for events to follow in the future.