공황장애환자에서 광장공포증 동반여부에 따른 스트레스대처방식의 차이

최은영,제영묘,이대수,정영인 대한생물치료정신의학회 2001 생물치료정신의학 Vol.7 No.1

In an attempt to know the factors affecting the development of agoraphobia following panic attacks, the author investigated whether there are differences between coping strategies of panic disorder with and without ago-raphobia. Thirty-seven patients meeting the criteria of DSM-IV panic disorder were divided into 2 subgroups, one group with agoraphobia, another without agoraphobia. Questionaires for the severity of panic symptoms, and of anticipating anxiety for panic attacks, multidimensional coping scale for stress were administered to panic subjects. The results were summarized as follows. 1) Group of panic disorder with agoraphobia complaints trembling or shaking more than group of panic disorder without agoraphobia. 2) There was no differences of degree for the severity of anticipating anxiety between two groups. 3) Group of Panic disorder with agoraphobia had higher score on BDI than Group of panic disorder without agoraphobia. 4) Group of panic disorder with agoraphobia had lower score on active coping, positive interpretation, acceptance than group of panic disorder without agoraphobia, and the differences of these strategies between two groups were not correlated with the score on BDI at the time of investigation. In conclusion, these results suggest that the coping strategies for stress may be a predictor of agoraphobia in patients with panic disorder.

불안장애의 위험주제

제영묘,김명정 大韓神經精神醫學會 1985 신경정신의학 Vol.24 No.1

In order to investigate the presence and the contents of the ideational components of the patients with the anxiety disorders, the authors studied 44 out-and inpatients of anxiety disorders diagnosed by the DSM-Ⅲ criteria at the neuropsychiatric department of Pusan National University Hospital. The results obtained were as follows. Forty three subjects out of 44 patients with anxiety disorders reported to recognize the ideational components of the themes of danger associated with anxiety experiences. 79.5 percent of the subjects had fears of physical disasters; 70.5 percent had psychological and 25 percent, social disasters. Twenty five of them reported two or three themes of danger simultaneously and 18 had themes of either physical or psychological disasters. Particularly there were many who had fear of death and fear of insanity simultaneously. A tendency of more prominent themes of physical disasters was noted in males, cases of acuteonset, cases with panic attacks and those with agoraphobia, and that of psychological disasters in females, cases of insidious onset and generalized anxiety disorder. But statistics failed to show significant difference probably due to insufficient numbers of the subjects. Surveying the contents of each theme, physical disasters were represented by fear of dying or death, psychological disasters by fear of insanity and social disasters by interpersonal rejection or social failure. From these results, the authors suggest that 1) themes of danger are consistently recognied by those with anxiety disorders during experiences of anxiety 2) the content and the intensity of the themes of danger have certain relationship with the intensity of anxiety 3) and the content of the themes of danger can be interpreted as the fear of annihilation.

Analysis of the Relationships Between ESD and DAP, and Image SNR⦁CNR According to the Frame Change of Cine Imaging in CAG : With Focus on 10 f/s and 15 f/s

Myo-Young Jung,Young-Hyun Seo,Jong-Nam Song,Jae-Bok Han 한국방사선학회 2018 한국방사선학회 논문지 Vol.12 No.5

X선 장비를 이용한 심장혈관 조영술 시 프레임 변화에 따른 입사 표면 선량과 흡수선량을 비교⦁분석하여 피폭의 차이를 알아보고자 하였고 image J를 통한 촬영 영상의 SNR과 CNR을 측정⦁분석하여 프레임 변화가 영상 화질에 주는 영향을 비롯해 검사에 있어 적절한 프레임 선택의 방안을 모색하고자 하였다. 2017년 6월부터 2017년 10월까지 본원에서 CAG를 시행한 30명(남19, 여11)을 대상으로 하였고, 환자들의 연령대는 49-82세(평균 65±9세), 몸무게45-91kg (평균 67±8.9kg), 키 150-179cm (평균 165.1±8.9kg), BMI 19.5-30.5(평균 24.5±2.9)이었다. 입사표면선량 및 흡수선량은 후향적으로 Air kerma값과 DAP를 획득하여 비교․분석 하였고 SNR과 CNR은 Image J를 통하여 측정⦁분석 한 후 공식에 대입하여 결과 값을 도출하였다. 통계 분석을 통한 상관관계 확인을 위해 통계프로그램은 SPSS를 사용하여 프레임 변화에 따른 입사표면선량과 흡수선량 및 SNR ․ CNR의 상관관계 등을 분석하였다. 10프레임으로 촬영할 때와 15프레임으로 촬영 할 때 모두 입사표면선량과 흡수선량관계는 통계적으로 유의하지 않았다(p>0.05). SNR과 CNR의 관계에선 10프레임으로 촬영했을 때의 SNR(3.374±2.1297)과 CNR(0.234±0.2249)이 15프레임에서의 SNR(4.929±2.8532)과 CNR(0.391±0.3025)보다 SNR1.43±0.4861, CNR 0.132±0.0555로 낮았으나 통계적으로는 유의하지 않았다(p>0.05). 상관관계 분석결과에서는 BMI와 air kerma, DAP간에, air kerma와 DAP간에, SNR과 CNR간에 통계적으로 유의한 결과를 얻었다(p<0.001, p<0.001). 결론적으로 심장혈관 조영술 시 10프레임과 15프레임으로 변화를 주어 촬영하여도 입사표면선량과 흡수선량은 큰 차이를 나타내지 않았으며, 10프레임보다 15프레임 촬영에서의 SNR과 CNR이 증가하였으나 통계적으로는 유의하지 않았기에 본 논문을 통해 환자와 시술자 모두 10프레임과 15프레임 촬영으로 인한 X선 피폭 문제뿐 아니라 영상의 화질감소에 관한 우려 역시 줄어들 수 있을 것으로 사료된다. This study aimed to investigate the difference of X-ray exposure by comparing and analyzing entrance surface dose and absorbed dose according to the frame change in coronary angiography using an X-ray machine. Moreover, appropriate frame selection measures for examination, including the effect of frame change on the image quality, were sought by measuring and analyzing the SNR and CNR of the image through image J. The study was conducted on 30 patients (19 males and 11 females) who underwent CAG at this hospital from June 2017 to October 2017. In regard to the patients, their age range was 49-82 years (mean of 65±9 years), body weight was 45-91 kg (mean of 67±8.9 kg), height was 150-179cm (mean of 165.1±8.9 kg), and BMI was 19.5-30.5(mean of 24.5±2.9). For the entrance surface dose and absorbed dose, air kerma value and DAP were obtained and analyzed retrospectively. The SNR and CNR were measured and analyzed through imageJ, and the result values were derived by applying the values to the formula. As for the statistical analyses, the correlations between the entrance surface dose and absorbed dose, and between the SNR and CNR were analyzed by using the SPSS statistical program. The relationship between the entrance surface dose and absorbed dose was not statistically significant for both 10 f/s and 15 f/s (p>0.05). In terms of the relationship between the SNR and CNR, the SNR (3.374±2.1297) and CNR (0.234±0.2249) in 10 f/s were 1.43±0.4861 and 0.132±0.0555 lower, respectively, than the SNR (4.929±2.8532) and CNR (0.391±0.3025) in 15 f/s, which were not statistically significant (p>0.05). In the correlation analysis, statistically significant results were obtained among the BMI, air kerma, and DAP; between air kerma and DAP; and between SNR and CNR (p<0.001, p<0.001). In conclusion, there was no significant difference between the entrance surface dose and absorbed dose even when the images were taken by changing the frame from 10 f/s to 15 f/s at the time of the coronary angiography. SNR and CNR increased at 15 f/s than at 10 f/s, but they were not statistically significant. Therefore, this study suggests that the concern of the patient and practitioner regarding image quality degradation, as well as the problem of X-ray exposure caused by imaging at 10 f/s and 15 f/s, may be reduced.

재활치료환자의 비위관(nasogastric tube)제거에 따른 비디오투시연하검사(VFSS)의 중요성 평가

정묘영(Jung myo-young),최남길(Choi nam-gil),한재복(Han jae-bok) 한국콘텐츠학회 2014 한국콘텐츠학회 종합학술대회 논문집 Vol.2014 No.11

심장혈관 조영술에서 씨네(cine)촬영의 프레임변화에 따른 ESD와 DAP 및 영상의 SNR⦁CNR 관계 분석: 10f/s과 15f/s을 중심 으로

정묘영(Myo-Young Jung),서영현(Young-Hyun Seo),송종남(Jong-Nam Song),한재복(Jae-Bok Han) 한국방사선학회 2018 한국방사선학회 논문지 Vol.12 No.5

X선 장비를 이용한 심장혈관 조영술 시 프레임 변화에 따른 입사 표면 선량과 흡수선량을 비교⦁분석하여 피폭의 차이를 알아보고자 하였고 image J를 통한 촬영 영상의 SNR과 CNR을 측정⦁분석하여 프레임 변화가 영상 화질에 주는 영향을 비롯해 검사에 있어 적절한 프레임 선택의 방안을 모색하고자 하였다. 20 17년 6월부터 2017년 10월까지 본원에서 CAG를 시행한 30명(남19, 여11)을 대상으로 하였고, 환자들의 연령대는 49-82세(평균 65±9세), 몸무게45-91kg (평균 67±8.9kg), 키 150-179cm (평균 165.1±8.9kg), BMI 19.5-3 0.5(평균 24.5±2.9)이었다. 입사표면선량 및 흡수선량은 후향적으로 Air kerma값과 DAP를 획득하여 비교․분석 하였고 SNR과 CNR은 Image J를 통하여 측정⦁분석 한 후 공식에 대입하여 결과 값을 도출하였다. 통계 분석을 통한 상관관계 확인을 위해 통계프로그램은 SPSS를 사용하여 프레임 변화에 따른 입사표면선량과 흡수선량 및 SNR ․ CNR의 상관관계 등을 분석하였다. 10프레임으로 촬영할 때와 15프레임으로 촬영 할 때모두 입사표면선량과 흡수선량관계는 통계적으로 유의하지 않았다(p>0.05). SNR과 CNR의 관계에선 10프 레임으로 촬영했을 때의 SNR(3.374±2.1297)과 CNR(0.234±0.2249)이 15프레임에서의 SNR(4.929±2.8532)과 C NR(0.391±0.3025)보다 SNR1.43±0.4861, CNR 0.132±0.0555로 낮았으나 통계적으로는 유의하지 않았다(p>0.0 5). 상관관계 분석결과에서는 BMI와 air kerma, DAP간에, air kerma와 DAP간에, SNR과 CNR간에 통계적으로 유의한 결과를 얻었다(p<0.001, p<0.001). 결론적으로 심장혈관 조영술 시 10프레임과 15프레임으로 변화를 주어 촬영하여도 입사표면선량과 흡수선량은 큰 차이를 나타내지 않았으며, 10프레임보다 15프레임 촬영에서의 SNR과 CNR이 증가하였으나 통계적으로는 유의하지 않았기에 본 논문을 통해 환자와 시술자 모두 10프레임과 15프레임 촬영으로 인한 X선 피폭 문제뿐 아니라 영상의 화질감소에 관한 우려 역시 줄어들 수 있을 것으로 사료된다. This study aimed to investigate the difference of X-ray exposure by comparing and analyzing entrance surface dose and absorbed dose according to the frame change in coronary angiography using an X-ray machine. Moreover, appropriate frame selection measures for examination, including the effect of frame change on the image quality, were sought by measuring and analyzing the SNR and CNR of the image through image J. The study was conducted on 30 patients (19 males and 11 females) who underwent CAG at this hospital from June 2017 to October 2017. In regard to the patients, their age range was 49-82 years (mean of 65±9 years), body weight was 45-91 kg (mean of 67±8.9 kg), height was 150-179cm (mean of 165.1±8.9 kg), and BMI was 19.5-30.5(mean of 24.5±2.9). For the entrance surface dose and absorbed dose, air kerma value and DAP were obtained and analyzed retrospectively. The SNR and CNR were measured and analyzed through imageJ, and the result values were derived by applying the values to the formula. As for the statistical analyses, the correlations between the entrance surface dose and absorbed dose, and between the SNR and CNR were analyzed by using the SPSS statistical program. The relationship between the entrance surface dose and absorbed dose was not statistically significant for both 10 f/s and 15 f/s (p>0.05). In terms of the relationship between the SNR and CNR, the SNR (3.374±2.1297) and CNR (0.234±0.2249) in 10 f/s were 1.43±0.4861 and 0.132±0.0555 lower, respectively, than the SNR (4.929±2.8532) and CNR (0.391±0.3025) in 15 f/s, which were not statistically significant (p>0.05). In the correlation analysis, statistically significant results were obtained among the BMI, air kerma, and DAP; between air kerma and DAP; and between SNR and CNR (p<0.001, p<0.001). In conclusion, there was no significant difference between the entrance surface dose and absorbed dose even when the images were taken by changing the frame from 10 f/s to 15 f/s at the time of the coronary angiography. SNR and CNR increased at 15 f/s than at 10 f/s, but they were not statistically significant. Therefore, this study suggests that the concern of the patient and practitioner regarding image quality degradation, as well as the problem of X-ray exposure caused by imaging at 10 f/s and 15 f/s, may be reduced.

재활치료환자의 비위관(nasogastric tube)제거에 따른 비디오 투시연하검사(VFSS)의 중요성 평가

정묘영(Myo young Jung),최남길(Nam gil Choi),한재복(Jae bok Han),송종남(Jong nam Song),김원진(Weon jin Kim) 한국방사선학회 2015 한국방사선학회 논문지 Vol.9 No.1

뇌경색, 뇌 신경장애 및 뇌졸중환자 중 급성기 환자는 의식이 없어 연하기능장애로 인한 흡인성 폐렴을 유발하기 때문에 비위관(nasogastric tube)을 삽입하고 영양공급을 한다. 재활훈련 후 회복기에 침상선별검사를 시행하지만 임상적 검사를 통해서는 무증상흡인은 발견할 수 없다. 그래서 연하장애로 비위관을 삽입한 연하재활치료 중인 환자 10명을 대상으로 VFSS를 시행하여 식이재료에 따른 삼킴 정도, 자세에 따른 삼킴을 재활의학과전문의가 평가 후, 흡인이 있거나 삼킴 곤란 등이 있으면 연하재활치료를 시행하여 환자의 상태에 따라 약 30일∼50일후에 재평가를 시행한 후 흡인이 없을 시 비위관을 제거 하였다. 이때 VFSS 영상을 기능적 연하곤란척도를 이용, 분석하여 부여된 점수를 통계 산출 하였는데 비위관 유지군은 49.79±9.431을 보여 흡인의 위험을 나타내며, 비위관 제거군은 11.20±1.932로 흡인의 위험성이 낮아 비위관 제거관련 의미 있게 낮은 점수를 보였다. 두 군의 유의성을 평가하기 위해 Mann-Whitney test를 시행한 결과 𝑝<0.001로 통계적으로 유의하다고 평가하였다. 결론적으로 VFSS는 구강, 인두, 식도의 구조적 이상과 움직임을 가장 효과적으로 평가, 기도흡인여부를 즉시 확인 및 환자에게 적합한 식이나 연하자세를 결정할 수 있어 비위관 제거를 위한 연하평가에 가장 확실한 표준검사로 제안할 수 있다. Acute phase patients who are unconscious and are suffering from cerebral infarction, cranial nerve disorders, or cerebral apoplexy are susceptible to aspiration pneumonia due to dysphagia. In these cases, a nasogastric tube is inserted to supply nutrients. Although bedside screening tests are administered during recovery after rehabilitation, clinical examinations may not be able to ascertain asymptomatic aspiration. Therefore, a video fluoroscopy swallowing study (VFSS) was performed in 10 patients with dysphagia after rehabilitation therapy; these patients had nasogastric tubes inserted, and a rehabilitation specialist assessed the degree of swallowing based on the patients' diet and posture. If aspiration or swallowing difficulties were observed, dysphagia rehabilitation therapy was administered. The patients were reassessed approximately 30 50 days after administration of therapy, based on the patients' condition. If aspiration is not observed, the nasogastric tube was removed. A functional dysphagia scale was used to analyze the VFSS images, and the scores were statistically calculated. The mean score of patients with nasogastric tubes was 49.79 ± 9.431, thereby indicating aspiration risk, whereas the group without nasogastric tubes showed a mean score of 11.20 ± 1.932, which indicated low risk of aspiration. These results demonstrated that a significantly low score was associated with nasogastric tube removal. Mann-Whitney's test was performed to assess the significance of both the groups, and the results were statistically significant with a P value <0.001. In conclusion, VFSS can effectively assess the movements and structural abnormalities in the oral cavity, pharynx, and esophagus. It can also be used to determine the aspiration status and ascertain the appropriate diet or swallowing posture for the patient. Therefore, VFSS can potentially be used as a reliable standard test to assess swallowing in order to determine nasogastric tube removal.

[P2-18] Effect of Harvest Time and Leal Size on Catechin Contents of Jang-Gun Cha, a Green Tea Produced in Gimhae

Mee-Young Lee,Ji-Na Choi,Ji-Min Park,Chul-Ho Jung,Jung-Yeon Kwon,Jung-In Kim,Myo-Jeong Kim 한국식품영양과학회 2007 한국식품영양과학회 학술대회발표집 Vol.2007 No.10

증감약제를 투여한 마우스에 고에너지 방사선 조사 후 혈액학적 변화에 관한 연구

정묘영(Jung Myo-Young),지연상(Ji Yeon-Sang),동경래(Dong Kyung-Rae) 한국콘텐츠학회 2009 한국콘텐츠학회 종합학술대회 논문집 Vol.7 No.1

최근 노인인구의 증가와 평균수명의 연장으로 암 발생빈도가 증가 추세에 있고, 암환자를 위한 방사선치료가 증가되면서 장해의 인식과 중요성이 널리 알려져 있다. 본 연구에서는 미량의 선량부터 고 선량의 방사선을 마우스에 조사하여 급성장해로 나타나는 혈액세포의 변화를 비교 실험함으로 종양치료 환자들의 조혈기계 장해를 알 수 있었다. 따라서 증감제 투여는 말초혈액 성분의 많은 장해를 초래할 수 있으므로 종양환자 치료 시 조혈기계 장해의 위험성을 고려해야 될 것으로 사료되며, 합리적인 방사선 치료가 이루어질 것으로 판단된다. The current population of elderly is increasing and the with an extended average lifespan, the frequency of cancerous occurrences have also increased, with these increases and the increase in radiotherapy for cancer patients, recognitions of harm and importance have become known. This article was known tumor treatment of patients with hematopoietic disorder by doing a comparative study on the changes in blood cells caused by the acute effects of trace dose to high dose of radiation exposed to mice. According to the sensitizer injection may give rise to harm to the components of peripheral blood. This material needs to be considered when for treating tumor patients and the risks of hematopoietic harm and believe that radiation therapy will be reasonable.

심장혈관 조영술에서 씨네(cine)촬영의 프레임변화에 따른 ESD와 DAP 및 영상의 SNR·CNR 관계 분석: 10f/s과 15f/s을 중심으로

정묘영 ( Myo-young Jung ),서영현 ( Young-hyun Seo ),송종남 ( Jong-nam Song ),한재복 ( Jae-bok Han ) 한국방사선학회 2018 한국방사선학회 논문지 Vol.12 No.5

X선 장비를 이용한 심장혈관 조영술 시 프레임 변화에 따른 입사 표면 선량과 흡수선량을 비교·분석하여 피폭의 차이를 알아보고자 하였고 image J를 통한 촬영 영상의 SNR과 CNR을 측정·분석하여 프레임 변화가 영상 화질에 주는 영향을 비롯해 검사에 있어 적절한 프레임 선택의 방안을 모색하고자 하였다. 2017년 6월부터 2017년 10월까지 본원에서 CAG를 시행한 30명(남19, 여11)을 대상으로 하였고, 환자들의 연령대는 49-82세(평균 65±9세), 몸무게45-91kg (평균 67±8.9kg), 키 150-179cm (평균 165.1±8.9kg), BMI 19.5-30.5(평균 24.5±2.9)이었다. 입사표면선량 및 흡수선량은 후향적으로 Air kerma값과 DAP를 획득하여 비교·분석 하였고 SNR과 CNR은 Image J를 통하여 측정·분석 한 후 공식에 대입하여 결과 값을 도출하였다. 통계분석을 통한 상관관계 확인을 위해 통계프로그램은 SPSS를 사용하여 프레임 변화에 따른 입사표면선량과 흡수선량 및 SNR · CNR의 상관관계 등을 분석하였다. 10프레임으로 촬영할 때와 15프레임으로 촬영 할 때 모두 입사표면선량과 흡수선량관계는 통계적으로 유의하지 않았다(p>0.05). SNR과 CNR의 관계에선 10프레임으로 촬영했을 때의 SNR(3.374±2.1297)과 CNR(0.234±0.2249)이 15프레임에서의 SNR(4.929±2.8532)과 CNR(0.391±0.3025)보다 SNR1.43±0.4861, CNR 0.132±0.0555로 낮았으나 통계적으로는 유의하지 않았다(p>0.05). 상관관계 분석결과에서는 BMI와 air kerma, DAP간에, air kerma와 DAP간에, SNR과 CNR간에 통계적으로 유의한 결과를 얻었다(p<0.001, p<0.001). 결론적으로 심장혈관 조영술 시 10프레임과 15프레임으로 변화를 주어 촬영하여도 입사표면선량과 흡수선량은 큰 차이를 나타내지 않았으며, 10프레임보다 15프레임 촬영에서의 SNR과 CNR이 증가하였으나 통계적으로는 유의하지 않았기에 본 논문을 통해 환자와 시술자 모두 10프레임과 15프레임 촬영으로 인한 X선 피폭 문제뿐 아니라 영상의 화질감소에 관한 우려 역시 줄어들 수 있을 것으로 사료된다. This study aimed to investigate the difference of X-ray exposure by comparing and analyzing entrance surface dose and absorbed dose according to the frame change in coronary angiography using an X-ray machine. Moreover, appropriate frame selection measures for examination, including the effect of frame change on the image quality, were sought by measuring and analyzing the SNR and CNR of the image through image J. The study was conducted on 30 patients (19 males and 11 females) who underwent CAG at this hospital from June 2017 to October 2017. In regard to the patients, their age range was 49-82 years (mean of 65±9 years), body weight was 45-91 kg (mean of 67±8.9 kg), height was 150-179cm (mean of 165.1±8.9 kg), and BMI was 19.5-30.5(mean of 24.5±2.9). For the entrance surface dose and absorbed dose, air kerma value and DAP were obtained and analyzed retrospectively. The SNR and CNR were measured and analyzed through imageJ, and the result values were derived by applying the values to the formula. As for the statistical analyses, the correlations between the entrance surface dose and absorbed dose, and between the SNR and CNR were analyzed by using the SPSS statistical program. The relationship between the entrance surface dose and absorbed dose was not statistically significant for both 10 f/s and 15 f/s (p>0.05). In terms of the relationship between the SNR and CNR, the SNR (3.374±2.1297) and CNR (0.234±0.2249) in 10 f/s were 1.43±0.4861 and 0.132±0.0555 lower, respectively, than the SNR (4.929±2.8532) and CNR (0.391±0.3025) in 15 f/s, which were not statistically significant (p>0.05). In the correlation analysis, statistically significant results were obtained among the BMI, air kerma, and DAP; between air kerma and DAP; and between SNR and CNR (p<0.001, p<0.001). In conclusion, there was no significant difference between the entrance surface dose and absorbed dose even when the images were taken by changing the frame from 10 f/s to 15 f/s at the time of the coronary angiography. SNR and CNR increased at 15 f/s than at 10 f/s, but they were not statistically significant. Therefore, this study suggests that the concern of the patient and practitioner regarding image quality degradation, as well as the problem of X-ray exposure caused by imaging at 10 f/s and 15 f/s, may be reduced.

의료제품의 장기추적조사 관련 제도현황과 중장기 추진방향

심다영(Da-Young Shim),이정은(Jeong-Eun Lee),최남경(Nam-Kyong Choi),정선영(Sun-Young Jung),김희진(Hee-Jin Kim),김선하(Seon-Ha Kim),김묘송(Myo-Song Kim),성희진(Hee-Jin Seong),신주영(Ju-Young Shin) 대한약학회 2020 약학회지 Vol.64 No.5

As the safety issues of medical products have been continuously generated, the need for long-term safety management, such as long term follow-up (LTFU), has been emerged. Current laws and regulations in Korea, however, have limitations to implement LTFU and track medical products immediately. This review examines the current status of safety management of medical products in Korea to propose future plan for establishing medical products LTFU system in Korea. We review the laws and regulations for safe use of medical products and compare regulations, definitions and processes in the following laws: Pharmaceutical Affair Act, Medical Device Act, Act on Safety and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals. In case of medicinal products except Advanced Biopharmaceuticals, regulations are needed to be developed and enforced even though there is legal basis for LTFU in Pharmaceutical Affair Act. In Medical Devices Act, there is no legal basis for conducting LTFU. Thus, establishing safety management regulation for LTFU in medical devices is essential. On the other hand, LTFU on advanced biopharmaceutical has implemented since this August with the new law. In order to conduct a LTFU and registry management, the regulatory science center should have a systematic process and manpower. Furthermore, to establish a LTFU system for all medical products, running pilot project is essential to evaluate feasibility. Public relations activities and training expertise to induce stakeholder participation is indispensable for successful implementation of LTFU.