Report on R Clinic (R-Clinic-FY1819-01)
Golden Jubilee Women’s Biotech Park (GJBP), Chennai
RIFC’s first R Clinic organized on 10th July 2018 at the Golden Jubilee Women’s Biotech Park (GJBP), Chennai, as a part of the “BIRAC TiE WinER program” under the initiative of BIRAC’s Regional BioInnovation Center (BRBC) at Venture Center. It was an interactive session between the “women entrepreneurs,” who are final participants of TiE WinER Award and “experts in the regulatory field.”
Wherein, it addressed the regulatory requirements and roadmap for securing the regulatory approvals, importance, and valuation of voluntary certifications in marketing a product in various jurisdictions. Also, the event enlightened the QMS, documentation requirements, identification, and mapping of applicable standards& guidelines.
Ms. Syamni Sasidharan, Quality Assurance Executive from MolBio Diagnostics Pvt. Ltd., Goa. She focused on the certification requirements, licensing process flow manufacture for sale or distribution, for In Vitro Diagnostic medical device and addressing the queries of licensing authorities under the new Medical Devices Rule 2017 of the D&C Act 1940 and the planning and preparation of Quality Management System as per ISO 13485:2016. She also clarified the route for clinical investigation of medical devices and clinical performance evaluation of In Vitro diagnostic medical device.
Mr. Anil Chaudhari, CEO of Operon Strategist, Pune. He explained the importance of Design Control at the early stage of product realization could avoid the post-market design changes, which ultimately lead to the business continuity and saves re-design cost. He showcased real-world examples of product recalls due to improper design, ignoring the user needs, not considering the historical incidents of relevant devices. A journey of Design Control as per 21 CFR 820.30 was an eye-opening for new entrepreneurs, where they understood the design input-output, a difference between verification and validation.
The overall feedback received was satisfactory, though there are certain areas where the entrepreneurs would like more information namely how to take their processes further and the companies/agencies that can help them with their entire regulatory process.
RIFC will be communicating with the entrepreneurs further to resolve their queries and or direct them to the appropriate consultants.
Some of the pointers for our next R Clinic would be:
Focus on areas of Biologics, Therapeutics, and drugs.
Cost vs. Compliance.
RIFC, Venture Center, Pune