Hello, this is CONNEXO.
We attended the 2024 1st Half PQM (Pharmaceutical Quality Management) Conference.
- Date: Friday, June 28, 2024
- Venue: Hotel Square by Savills (Ansan, Gyeonggi Province, South Korea)
The PQM Conference is held twice a year, bringing together quality professionals from leading domestic bio/pharmaceutical companies and regulatory authorities to share various quality-related cases and regulatory updates.
This year’s first-half event was particularly noteworthy due to new developments announced in the Ministry of Food and Drug Safety’s recently introduced “Food and Drug Regulatory Innovation 3.0.” These included:
- “Simplification of Drug Approval Evaluation Documents”
- “Extension of GMP Validity Periods Through Paper-Based Assessments” for low-risk manufacturing facilities
- Improvement of drug assessment procedures by incorporating digital reference standards for absorption spectrums into the pharmacopeia, enabling conformity decisions through single-sample tests.
Main Topics:
- Practical Applications and Case Studies of Annex 1 and CCS (SK Bioscience Co., Ltd.)
- Enhancing Documentation Efficiency in Quality Departments and AI Utilization Strategies (Daewoong Bio Co., Ltd.)
- What Makes a Good GMP Inspection (Medical Products Inspection Division, Korea Regional Food and Drug Administration)
- Recent Major GMP Violations (Medical Products Safety Division, Korea Regional Food and Drug Administration)
At this event, CONNEXO hosted a booth to showcase NovaTech Environmental Monitoring, Nova Cleaning Validation, and TrackWise. This provided us with the opportunity to introduce our solutions to attendees and provide detailed explanations.