Representative Career [ Personal Data ] * Name : In Ok Kim * Date of Birth : 7/20/1973 * Gender : Female |
▣ Education | |
Sook-Myung Women's University (BS, Major : Pharmacy ) | Mar. 1993 - Feb. 1997 |
Jung-Ang University (MS, Major : Cosmetics Sciences) | Sep. 2006 - Aug. 2008 |
SungKyunKwan University (completed Doctorate course: Pharmacy) | Sep. 2013 - Aug. 2015 |
▣ Language | |
Fluent in verbal and written English; proficient in Japanese to conduct international regulatory affairs |
▣ Training(02-19 GMP & Related Topics (40 hours *1-2 times/year) & Qualification | |
Licensed Administrative Agent (No. 20-4038) | 20 |
PIC/s Expert circle (CCCISF ; Control of Cross of Cross Contamination in Shared Facilities) WHO Expert meeting (Concept note for WLA; WHO Listed Authorities) | 19 |
PDA Analytical Method Qualification, Validation, Verification, and Transfer for Biotechnicals |
18 |
Training program of Good Manufacturing Practice Auditor on medical devices (40 hours) Advanced Training program of GMP Auditor on medical devices (ISO13485 : 2016, 40 hours) | 16 |
PIC/s Expert circle meeting on Auditing of ERP/MRP, computerized Lab, PAT system | 09 |
WHO Global Training Network on Vaccine Quality 'GMP" course (40 hours education) | 07 |
01 U.S. DEA's International Chemical Control and Investigation Seminar (40 hours education) | 01 |
pharmacist License Registration | 97 |
▣ Awards | |
MFDS's citation (pharmaceuticals surveillance), Gwacheon city's citation (create happy city) | 19 |
MFDS's Encouragement Prize (cosmetics GMP evaluation information sharing system) | 18 |
Grand Prize at the National Idea Contest (pharmaceutical Product name pre-screening) | 15 |
KFDA's Innovation star by all the staff's evaluation (brainstorm-leader to solve the problems) | 07 |
KFDA's Narcotics-withdrawal contributions citation (area of treatment of drug offenders) | 00 |
▣ Work Experience (Total : 22 years 9 months) | |
Representative Consultant, INNOK Corporation (GMP issues & Registration.) | 20.02~Present |
Renewal of KGMP certificate(Hamsoa pharmaceutical company), advisor(GLG, KPBMA, KPTA) | 20.07 |
Application of quasi-drug manufacturer & Facility investigations, BTK, etc. | 20.06 |
International Marketing Research including status of Licensing of contrast agent, AHPharm | 20.05 |
QA& RA advisor, SIRES/ consult on CMO of Biological product, Sartprius | 20.04 |
Research of pesticide license & GVMP training, SHBC veterinary drug manufacturer | 20.03 |
My Careers at MFDS, KFDA, MHW (Deputy Director, 22 years 4 months) | 97.09-20.02 |
Biopharmaceutical Policy Division, MFDS (the Ministry of Food & Drug Safety) R&D (establishment of Microbiome Therapeutics license system, BIO IT platform, etc.) | 19.08-20.02 |
Medical Products Inspection Division, Gyeongin Food and Drug Safety, Director Pharmaceuticals, Medical Devices, Cosmetics GMP Inspector & Training, Team Manager | 15.09-19.08 |
Research leave, SKKU, R&D of standardization of Health Information | 14.09-15.09 |
Risk Investigation Team, Medical Products Inspection Division, Daejeon FDS Investigator, GMP Inspector of pharmaceuticals, Medical Devices, Cosmetics & Training | 13.06-14.09 |
Pharmaceutical Policy Division, MFDS | 13.03-13.06 |
Pharmaceutical Policy Division, MFDS System development, International Cooperation (U.S. FDA, CDISC, ICH MSSO, DIA), etc. | 13.03-13.06 |
Drug Review Management Division, Drug Evaluation Department, KFDA Pharmaceutical application review, establishment of CDISC based e-CTD Gateway | 12.06-13.03 |
overseas leave with my husband's MBA study at Melbourne university in Australia | 10.07-12.06 |
overseas leave with my husband's MBA study at Melbourne university in Australia | 10.07-12.06 |
Pharmaceutical Quality Division, KFDA, Trainer of GMP inspector (Study Circle) | 08.11-10.07 |
Pharmaceutical Quality Division, KFDA, Trainer of GMP inspector (Study Circle) Pharmaceuticals GMP Inspector, International Cooperation, validation guideline | 08.11-10.07 |
Pharmaceutical Biopharmaceutical Management TFT, KFDA Biopharmaceuticals GMP Inspector, High Risk Biological diagnostics management policy | 06.11-08.11 |
Medical Products Safety Division, Seoul Regional KFDA, PMS Team manager Issue/evaluation/surveillance of Medical Products, PMS (overdone, false Ad., Etc.), KGSP | 02.08-06.11 |
Medical Products Safety Division, Kwangju Regional KFDA Approval/evaluation/surveillance of Medical Products, PMS(overdone, false Ad., Etc.) | 00.12-02.08 |
Narcotics Management Division, KFDA Approval/Allocation/surveillance of Narcotics, cooperation of International(INCB), /concerned agencies(prosecutor, customs, etc.), treatment/campaigns(addicted patients) | 99.03-00.12 |
Division of Pharmaceutical Policy, MOHW (The Ministry of Health and Welfare) enacted and interpreted the pharmaceutical laws(regulations), Regulatory reform, etc. | 98.02-99.03 |
New Drug Development Division, MOHW (The Ministry of Health and Welfare) Support the R&D of New drug precursor and designate and supervise GLP labs, etc | 97.09-98.02 |
▣ Special achievements | |
* Completed permit processing of microbiome therapeutics, provided biopharmaceutical companies with regulatory & license information and drove regulatory reforms through annual meetings. | |
* worldwide prominent key note speaker and 2020 theme title of Global Bio Conference. | |
* developed GMP inspectors training programs (eg. mentor-mentee, weekly seminars, peer review) | |
* developed GMP inspectors training programs (eg. mentor-mentee, weekly seminars, peer review) | |
* GMP inspection of medical products (pharmaceuticals 500s, devices 250s, Cosmetics 60s) and overseas & domestic manufacturing sites(+150s), especially coped with EU WHITELIST's evaluation | |
* evaluated and reviewed medical product application(DMF) (+1,000s) & Surveillances(+500s) | |
* established the overall strategies to join PIC/S and developed CDISC based e-CTD license system. | |
* established GMP guidelines of Computer system validation, designation of Biologicals Testing Institution, clinical cell & gene therapeutics, High Risk Diagnostics product (HIV, HBV, HCV), etc. | |
* participated in diverse PIC/S Expert circle, WHO Consultative conference on the policy of WHO Listed Authority, and spread the knowledge and the trend on that to stakeholders. |