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.