The Korea Institute of Drug Safety and Risk Management (KIDS) said that it has conducted the 2019 KIDS-APEC Pharmacovigilance Center of Excellence (CoE) training program from Sept. 4-5.
|Participants share a moment during the 2019 KIDS-APEC Pharmacovigilance Center of Excellence conference, held at the Best Western Premier Seoul Garden Hotel located in Mapo-gu, Seoul, on Wednesday.|
The APEC Regulatory Harmonization Steering Committee (RHSC) endorsed KIDS to conduct the APEC Pharmacovigilance CoE Pilot Program in 2016, and also designated it as the formal CoE in 2017. After the designation, the agency has been holding the program annually.
This year, regulators and speakers from 15 countries -- Azerbaijan, Cambodia, Chile, Indonesia, Japan, Korea, New Zealand, Peru, Philippines, Saudi Arabia, Singapore, Sweden, Taiwan, Thailand, U.S -- participated in the program. The purpose of this training is to support harmonization and capacity building within the APEC region and share the recent trends in pharmacovigilance field, KIDS said.
The programs consisted of lectures and a hands-on exercise that cover key topics in the whole lifecycle of pharmacovigilance, such as adverse event reporting, collecting, analysis and evaluation, decision-making, safety measures, and risk communication.
This year’s training provided new topics, such as medication error reporting system, pharmacovigilance inspection, enhanced practical exercise on the medical dictionary for regulatory activities (MedDRA), and signal detection.
The program also included sessions to introduce the pharmacovigilance system and share the action plans for the regulatory harmonization in pharmacovigilance of Korea, as well as a session for participants from various APEC economies to share their experiences and strategies to improve the pharmacovigilance system.
“I hope the program this year provided a great opportunity to share experience and challenges in each country and also enhance the regulatory capacity in pharmacovigilance,” KIDS President Han Soon-young said. “KIDS will continue to strive to provide better programs that fulfill participants’ needs.”