On June 28, 2024, CONNEXO attended the 2024 1st Half Pharmaceutical Quality Management (PQM) Conference, held at Hotel Square by Savills in Ansan, Gyeonggi Province, South Korea. This semiannual event brings together quality professionals from Korea’s leading bio and pharmaceutical companies, as well as key representatives from regulatory bodies, to share practical case studies and updates on evolving standards.

This year’s conference was especially significant with updates tied to the Ministry of Food and Drug Safety’s “Food and Drug Regulatory Innovation 3.0” initiative. Highlights included:

• Simplified documentation for drug approval evaluations

• Extended GMP validity through paper-based assessments for low-risk manufacturing sites

• Improved assessment procedures via digital reference standards for absorption spectra, enabling single-sample conformity tests

The agenda featured in-depth sessions such as:

• Annex 1 and CCS Case Studies (SK Bioscience Co., Ltd.)

• AI in Quality and Documentation Efficiency (Daewoong Bio Co., Ltd.)

• Best Practices for GMP Inspections (Korea Regional Food and Drug Administration, Medical Products Inspection Division)

• Recent GMP Violations and Trends (Medical Products Safety Division)

At the conference, CONNEXO hosted a booth featuring NovaTech Environmental Monitoring, Nova Cleaning Validation, and TrackWise®. The event provided a valuable opportunity to demonstrate our digital solutions in real time and discuss how we support compliance, operational efficiency, and data-driven decision-making in regulated environments.

We appreciate the interest and engagement from all attendees and look forward to further collaboration with the Korean life sciences community.

For more information, contact us at [email protected]