ICSQA Annual Conference 2017: Good Laboratory Practice Regulatory Quality System for Non-clinical studies: Global Requirements and Trends

Natesan Settiagounder PhD, RQAP-GLP, President ICSQA
Satish Murthy V, MSc, RQAP-GLP, Secretary ICSQA
Muktha Bhagavan MSc, RQAP-GLP, Treasurer ICSQA

In this news article, we wish to furnish highlights of the Indian Chapter of SQA (ICSQA) Conference held 10-11 August 2017 at Advinus Therapeutics Limited, Bengaluru. A total of 113 professionals participated in the conference. The inaugural speech was given by Dr. Ekta Kapoor, Scientist E and Full time GLP Inspector from the Indian National GLP Compliance Monitoring Authority (NGCMA), and the keynote speech was delivered by Dr. Vinita Sharma, the former head of NGCMA. Participants included QA professionals, scientists, study personnel, business development personnel and project management professionals from various organizations including testing facilities, research institutes, sponsors, independent consultants, and others.

The key objectives of the conference were:

  • Education through information exchange and knowledge sharing

  • Bringing together professionals to deliberate on the requirements and challenges of GLP quality systems

  • To promote a high level of regulatory quality and compliance

There were six sessions, as detailed below:

Session 1: GLP - Global Regulations and Recent Changes

Session 2: Challenges of Multi-site Studies

Session 3: Requirements of Pathology Peer Review

Session 4: Computer System Validation and Data Integrity

Session 5: SEND Requirements for U.S. FDA Submissions

Session 6: Checks and Balances for Improving Compliance

Overall, there were sixteen presentations by professionals. Additionally, there was a separate open “Panel Discussion” to address a range of general questions relating to GLP regulations, requirements, challenges, and approaches. On day 1 of the conference, there was a cultural program in the evening, performed by the Advinus cultural program team.

Overall, the conference went well with lots of appreciation for the organizers and for Advinus for providing support for conducting the program. The feedback expressed by participants was very much encouraging for organizers.

A few photographs taken during the program are produced below: