식품의약품안전처 자문
2024.07 Expert Advisory Meeting for the use of real-world data in depression clinical trials
2023.10 Expert Advisory Meeting for Korean-guideline of multiple endpoints
2023.09 Expert Advisory Meeting for Korean-guideline of ICH E9(R1)
2023.08 Expert Advisory Meeting for the efficacy of a new drug for COVID19
2023.04 Expert Advisory Meeting for dissolution test using Bootstraps method in model-independent method
2023.03 Consulting for statistical significance and clinical significance of a cell therapy
2023.02 Consulting for bioequivalence study design when the brand-name drug was approved with two doses for two different subgroups
2023.02 Central Pharmaceutical Affairs Council, Issues on protocol amendment of a new treatment of COVID19
2022.09 Central Pharmaceutical Affairs Council, Issues on clinical significance of a cell therapy for gonarthritis.
2022.01 Central Pharmaceutical Affairs Council, Issues on statistical significance of Sacubitril and Valsartan for CHF.
2021.11 Consultation for statistical issues of health functional food
2021.08 Consultation for statistical issues of health functional food
2019.12 Central Pharmaceutical Affairs Council, Issues on the prospective/ retrospective observational and registry trial for the development of new drugs for chronic Graft versus host disease.
2019.11 Central Pharmaceutical Affairs Council, Issues on real data use for the development of new drugs for chronic Graft versus host disease.
2019.09 Central Pharmaceutical Affairs Council, Issues on Keytruda for the second line therapy of head and neck cancer.
2019.08 Central Pharmaceutical Affairs Council, Issues on futility analysis of a anticancer drug.
2019.07 Expert Advisory Meeting for dissolution test using f2 metric.
2019.06 Central Pharmaceutical Affairs Council, Issues on the bioequivalence study of omega 3.
2019.04 Central Pharmaceutical Affairs Council, Issues on a cell therapy for acne scar
2019.04 Consulting for the sample size calculation of diagnostic medical device
2019.04 Central Pharmaceutical Affairs Council, Issues on efficacy of irritable bowel syndrome.
2019.03 Central Pharmaceutical Affairs Council, Issues on the indication of a cell therapy
2019.02 Interviewer of new statistical reviewers for MFDS
2019.02 Central Pharmaceutical Affairs Council, Issues on the hyperlipemia combination drug
2019.01 Central Pharmaceutical Affairs Council, Issues on the efficacy of a cell therapy product for improvement of scars associated with healing process of acne.
2018.12 Central Pharmaceutical Affairs Council, Issues on the second line therapy Atezolizumab for papillary carcinoma
2018.12 Central Pharmaceutical Affairs Council, Issues on the proposed phase III protocol of a cell therapy product for anaplastia gonarthritis
2018.11 Central Pharmaceutical Affairs Council, Issues on the proposed phase I+II protocol of a cell therapy product
2018.11 Consulting for a laser medical product for hair growth
2018.11 Consulting for AI aided diagnostic medical device
2018.11 Expert Advisory Meeting for the development of guidelines for clinical trials for cell therapy products
2018.10 Central Pharmaceutical Affairs Council, Issues on the proposed protocol of a cell therapy product for conditional approval
2018.09 Central Pharmaceutical Affairs Council, Issues on the revised protocol of Streptokinase
2018.08 Central Pharmaceutical Affairs Council, Issues revision of statistical methods for bioassay in the Korean Pharmacopoeia.
2018.08 Consulting for computer aided detection diagnostic medical device
2018.07 Expert Advisory Meeting for bioequivalence of lung inhalant
2018.07 Expert Advisory Meeting for a cell therapy product
2018.07 Central Pharmaceutical Affairs Council, Issues on the hyperlipemia combination drug
2018.06 Consulting for sample size calculation in revised protocol of Streptokinase
2018.06 Expert Advisory Meeting for bioequivalence study with significant carryover effects
2018.06 Central Pharmaceutical Affairs Council, Issues on the protocol amendment of mesenchymal stem cell treatment for amyotrophic lateral sclerosis
2018.05 Central Pharmaceutical Affairs Council, Issues on the re-evaluation of efficacy of Streptokinase
2018.04 Central Pharmaceutical Affairs Council, Issues on the re-evaluation of efficacy of Talniflumate
2018.03 Central Pharmaceutical Affairs Council, Issues on the changes of the number of cases in post-marketing study of Pazopanib
2018.03 Central Pharmaceutical Affairs Council, Issues on efficacy and safety of a stem cell therapy for degenerative arthritis.
2018.02 Consulting for the use of historical control in a rare disease (multiple myeloma)
2018.01 Central Pharmaceutical Affairs Council, Issues on safety of intestinal cleanser with Sorbitol
2017.08 Expert Advisory Meeting for functional cosmetic (dryness due to atopic skin)
2017.08 Expert Advisory Meeting, Issues on medical devices
2017.07 Expert Advisory Meeting for the selection between the risk difference and the relative risk in MRCT. Herceptin Biosimilar for Samsung Bioepis.
2017.07 Central Pharmaceutical Affairs Council, Issues on efficacy and safety of Ursa : 2nd meeting
2017.06 Central Pharmaceutical Affairs Council, Issues on efficacy and safety of a gene therapy (Invossa) : 2nd meeting
2017.06 Central Pharmaceutical Affairs Council, Issues on safety of intestinal cleanser with Sorbitol
2017.04 Central Pharmaceutical Affairs Council, Issues on reviewing protocol of Circulan for re-evaluation of efficacy
2017.04 Central Pharmaceutical Affairs Council, Issues on efficacy and safety of a stem cell therapy
2017.04 Central Pharmaceutical Affairs Council, Issues on efficacy and safety of a gene therapy (Invossa) : 1st meeting
2017.04 Central Pharmaceutical Affairs Council, Issues on efficacy and safety of Ursa : 1st meeting
2017.03 Expert Advisory Meeting for exact confidence intervals for evaluation of vaccine efficacy
2017.03 Central Pharmaceutical Affairs Council, Issues on the changes of the number of cases in post-marketing study of a cell therapy product
2017.02 Expert Advisory Meeting for Meditoxin in treatment of cervical dystonia
2017.01 Central Pharmaceutical Affairs Council, Issues on safety of intestinal cleanser with Sorbitol
2017.01 Expert Advisory Meeting for evaluating pharmacokinetic study of Raloxifene
2016.12 Expert Advisory Meeting, Issues on medical devices
2016.11 Central Pharmaceutical Affairs Council, Issues on safety of intestinal cleanser with Sorbitol
2016.10 Central Pharmaceutical Affairs Council, Issues on the re-evaluation of efficacy of Zipeprol
2016.06-2016.12 Investigations for preparing scientific guideline of evaluating biosimilarity
2016.09 Central Pharmaceutical Affairs Council, Issues on the re-evaluation of efficacy of Circulan
2016.08 Meeting for multi-regional clinical trial working group
2016.07 Consulting for clinical trial design of acute Pneumococcal
2016.07 Central Pharmaceutical Affairs Council, Issues on the efficacy of Medi-toxins
2016.06 Consulting for clinical trial design of acute bacterial sinusitis
2016.04 Central Pharmaceutical Affairs Council, Issues on the efficacy of Mosapride for functional dyspepsia.
2016.02 Consulting for bioequivalence study with clinical endpoint in eye bath drop.
2016.01 Central Pharmaceutical Affairs Council, Issues on the development of Varicella vaccine.
2016.01 Organizing Committee for Global Bio Conference 2016
2016.0-1 Committee for revising the guideline “Basic Principles of Clinical Trials in Korea”
2015.09 Consulting for the determination of Korean sample sizes in multi-regional vaccine clinical trials
2015.08 Contribution for the development of Korean statistical guideline for clinical trials
2015.08 Consulting for sample size recalculation based on unblinded interim analysis
2015.07 Consulting for evaluation of efficacy of a new treatment for rare disease (Buerger’s disease)
2014.10 Expert Advisory Meeting, Issues on medical devices
2013.05 Expert Advisory Meeting, Issues on medical devices
2012.10 Consultation for revision of guidelines for antibiotics
2011.11 Expert Advisory Meeting, Issues on biosimilar products
2010.12 Central Pharmaceutical Affairs Council, Issues on the efficacy of glucosamine.
2010.07 Central Pharmaceutical Affairs Council, Issues on the safety of Sibutramine (Abbott).
2010.03 Central Pharmaceutical Affairs Council, Issues on the efficacy and safety of poweracen solution in fatigue patients.
2010.01 Central Pharmaceutical Affairs Council, Issues on the efficacy and safety of nicorandil for acute heart failure.
2009.10 Central Pharmaceutical Affairs Council, Issues on the revision of bioequivalence criteria for highly variable drug.
2009.09 Central Pharmaceutical Affairs Council, Issues on the efficacy and safety of theophyline for asthma in children.
2009.03 Central Pharmaceutical Affairs Council, Issues on waiver of therapeutic confirmatory clinical trials of docetaxel for metastatic esophageal cancer (Sanofi-Aventis)
2008.12 Central Pharmaceutical Affairs Council, Issues on the efficacy and safety of Rotarix for Rotavirus (GlaxoSmithKline Biologicals)
2008.11 Central Pharmaceutical Affairs Council, Issues on assessing and comparing to the safety of ‘SK Chemicals SK influenza V vaccine inj’ and ‘Sanofi Pasteur inj’ in Korea healthy children and adolescents.
2008.03 Central Pharmaceutical Affairs Council, A Phase I experimental medicine study to validate pharmacodynamic pain assessment in healthy volunteers in a randomized double blind placebo controlled two way crossover design with an opioid analgesic (Remifentanil)
2008.03 Deliberation of the plan of internal research in Department of Applied Statistics in KFDA
2008.02 Consulting for a biostatistician in KFDA, EMEA guideline <Points to consider on adjustment for baseline covariates>
2008.02 Consulting for a biostatistician in KFDA, EMEA guideline <On missing data>
2008.01 Consulting for a biostatistician in KFDA, EMEA guideline <Points to consider on multiplicity issues in clinical trials>
2008.01 Consulting for a biostatistician in KFDA, ICH E9 <Statistical principles for clinical trials>
2007.12 Consulting for a biostatistician in KFDA, Multiple testing
2007.11 Deliberation of internal research in Department of Applied Statistics in KFDA
2007.11 Consulting for a biostatistician in KFDA, subgroup analysis
2007.10 Consulting for a biostatistician in KFDA, non-inferiority trials
2007.09 Consulting for a biostatistician in KFDA, sample size determination
2007.06 Consulting for a biostatistician in KFDA, stratification