European Regulatory Science and Regulatory Science Expert Training Project

Background@#Need for regulatory science is emerging with the development of pharmaceutical industry. It is essential to train regulatory science experts to meet the needs of technology and regulations to evaluate advanced products. Major regulatory science countries are conducting the regulatory science activities and fostering the experts. @*Methods@#Published literature and the relevant website of European Union (EU) were reviewed and criteria were developed. In particular, we focused on in depth descriptions of the Innovative Medicines Initiative program, which was conducted twice. @*Results@#EU is striving to provide funding and training experts for the development of the regulatory science by horizon 2020 and regulatory science to 2025. Innovative medicines initiative (IMI) is a public-private partnership aimed at the development of the pharmaceutical industry, including the regulatory science. IMI education and training projects have provided various education and training course including short-term curriculum and master and doctoral course. The difference between South Korea’s regulatory science expert training project in 2021 and the EU’s IMI education and training projects is participation of pharmaceutical companies. While the pharmaceutical companies participate in the IMI project to select project topics and form a community, South Korea’s project is focused on the Ministry of Food and Drug Safety and universities. @*Conclusion@#Through successful active networks with regulatory party, pharmaceutical companies, and universities, a great innovative advance of regulatory science in South Korea is expected.

Analysis of Trends in Regulatory Science and Regulatory Science Experts Training Projects: US, Japan, Singapore, and Korea

Background@#The need for regulatory science development to evaluate advanced regulatory products is gradually increasing without hindering the technological development. Creating a research environment and fostering experts through the establishment of regulatory agency-led policies are essential for the development of regulatory science. Method: This is a comparative study of the United States, Japan, Singapore, and Korea. The literature and websites of each regulatory agency were reviewed, and the focus was on advantages and comparing advantages based on definition, development trends, and expert training projects. @*Results@#The United States is striving to develop regulatory science in response to changes in the new pharmaceutical industry through the regulatory science report, and to foster expert both inside and outside the Food and Drug Administration (FDA). Japan is promoting regulatory science centered on regulatory science centers, and is focusing on researching work-related regulatory science within the Pharmaceuticals and Medical Devices Agency (PMDA) and improving employees’ ability to make regulatory decisions. Singapore was aiming to improve Southeast Asia’s regulatory capabilities under the leadership of Centre of Regulatory Excellence (CoRE) within Duke-NUS University. In 2021, Korea is in its early stages, starting to run a university's degree program related to regulatory science this year. @*Conclusion@#Regulatory science should be developed with the aim of improving the regulatory ability of the Ministry of Food and Drug Safety with Korea’s independent concept of regulatory science.

European Regulatory Science and Regulatory Science Expert Training Project

Background@#Need for regulatory science is emerging with the development of pharmaceutical industry. It is essential to train regulatory science experts to meet the needs of technology and regulations to evaluate advanced products. Major regulatory science countries are conducting the regulatory science activities and fostering the experts. @*Methods@#Published literature and the relevant website of European Union (EU) were reviewed and criteria were developed. In particular, we focused on in depth descriptions of the Innovative Medicines Initiative program, which was conducted twice. @*Results@#EU is striving to provide funding and training experts for the development of the regulatory science by horizon 2020 and regulatory science to 2025. Innovative medicines initiative (IMI) is a public-private partnership aimed at the development of the pharmaceutical industry, including the regulatory science. IMI education and training projects have provided various education and training course including short-term curriculum and master and doctoral course. The difference between South Korea’s regulatory science expert training project in 2021 and the EU’s IMI education and training projects is participation of pharmaceutical companies. While the pharmaceutical companies participate in the IMI project to select project topics and form a community, South Korea’s project is focused on the Ministry of Food and Drug Safety and universities. @*Conclusion@#Through successful active networks with regulatory party, pharmaceutical companies, and universities, a great innovative advance of regulatory science in South Korea is expected.

A Vasculitis, Caused by Neurocysticercosis, Can Mimic Moyamoya Disease

Neurocysticercosis (NCC) is the most common central nervous system parasite infection, frequently produces seizure, headache, or hydrocephalus as clinical manifestations. Cerebral vasculitis is an infrequent complication of the clinical phenotype of NCC. Moreover, NCC involving basal cerebral arteries, including distal internal carotid artery or middle cerebral artery, has rarely been reported. Therefore, we present a case of NCC with moyamoya-like basal cerebral arterial steno-occlusive disease with an emphasis on the differential diagnosis.

Sleep and Nocturia in Under Age 50 Male Patients with Obstructive Sleep Apnea Syndrome

Objectives@#To investigate the prevalence of nocturia in young patients with obstructive sleep apnea syndrome (OSAS) and to find out the risk factors of nocturia in the patients. @*Methods@#We enrolled 415 untreated male OSAS patients (apnea-hypopnea index, AHI ≥5/h on polysomnography) who were under 50 years old (mean age 37.5±8.0 years). Participants completed Korean version of Beck depression inventory II (K-BDI-II), Pittsburgh sleep quality index-Korean (PSQI-K), insomnia severity index (ISI), and Epworth sleepiness scale (ESS). Participants were classified into nocturia and non-nocturia group according to the following question “Do you find yourself waking up to urinate more than twice each night?” All information was compared between two groups. @*Results@#22.7% (94/415) of patients reported to have nocturia. Patients with nocturia had higher score of K-BDI-II, PSQI-K, ISI, and ESS although their age and the proportion of consumption of alcohol or caffeine and metabolic diseases were not different from patients without nocturia. AHI was not significantly higher in nocturia group (38.0±29.2/h) than non-nocturia group (32.8±25.7/h, p=0.118), however, parameters indicating sleep quality were worse in nocturia group, i.e. lesser non-rapid eye movement sleep stage 3 (N3) sleep % and higher arousal index, total apnea index, and 90% oxygen desaturation index (ODI). 90% ODI and N3 sleep % were revealed to be independent factors associated with nocturia. @*Conclusions@#Considerable numbers of male OSAS patients who are under 50 years suffer from nocturia and they have worse sleep quality compared to non-nocturia patients. Higher oxygen desaturation and lesser N3 sleep % are highly predictive factors for nocturia rather than AHI in these patients.

An Unexpected Death Related to Accidental Gasoline Inhalation / 대한법의학회지

Gasoline is a chemical compound of aliphatic and aromatic hydrocarbons, and it easily vaporizes because of its volatile characteristics. Gasoline inhalation may occur accidentally or intentionally in various situations which could result in acute non-lethal or lethal intoxication. Given that gasoline is widely used in everyday life, it is surprising that deaths related to gasoline inhalation rarely occur. We presented a rare case of unexpected death related to gasoline inhalation with the postmortem findings and features.

Spontaneous Extracranial Vertebral Artery Dissection in a Neurofibromatosis 1 Patient with Bilateral Intrathoracic Spinal Meningoceles around the Scoliosis: Report of an Autopsy Case / 대한법의학회지

Neurofibromatosis 1 (NF1) is a common autosomal dominant disorder that causes several systemic diseases. Many studies have reported that NF1 is associated with intrathoracic meningoceles and scoliosis. The incidence of vertebral artery dissection is estimated to be 1-1.5 per 100,000 population. We experienced an autopsy case of massive intrathoracic hemorrhage due to spontaneous vertebral artery dissection in a patient with NF1, who had intrathoracic spinal meningoceles and scoliosis. A 47-year-old man was found dead at his home in the morning. He had a history of NF1 including numerous cutaneous neurofibromas and hyperpigmented macules, scoliosis, and deformity of the leg. The autopsy revealed the dissection and rupture of the left vertebral artery, and a pseudocyst that had formed due to arterial leakage on the wall of the meningocele on the left side. The pseudocyst had eventually ruptured and leaked blood, resulting in a massive hemothorax on the left side. Thus, it was revealed that the patient had suffered from NF1-associated intrathoracic meningoceles and scoliosis, and we concluded that the cause of his death was a massive hemothorax on the left side, caused by the dissection and rupture of the left vertebral artery.

Death due to Gastrointestinal Hemorrhage Associated with Dieulafoy's Lesion / 대한법의학회지

Dieulafoy's lesion is a rare condition that may cause intermittent or massive gastrointestinal bleeding. It is characterized by the exteriorization of an arterial vessel into the lumen of the affected organ, generally the upper digestive tract, through an apparently normal mucosa or a small tear or erosion. We report two patients with Dieulafoy's lesions, one in whom the lesion was misdiagnosed as a submucosal tumor and endoscopic biopsy resulted in fatal bleeding.

Ruptured Subvalvular Aortic Aneurysm of a Person Who Has Bicuspid Aortic Valve / 대한법의학회지

Subvalvular aortic aneurysms are rare but can be a cause of sudden death. This case report involves a 36-year-old male who died suddenly from rupture of a subvalvular aortic aneurysm with resultant hemopericardium with tamponade. He had a bicuspid aortic valve with acute infective endocarditis. A review of the literature enlightens the association between bicuspid aortic valve and subvalvular aortic aneurysm. The pathogenesis of the diseases of the aortic root will be discussed.

Drowning Death due to an Epileptic Attack of a Patient with Sturge Weber syndrome: An Autopsy Report / 대한법의학회지

Sturge Weber syndrome (SWS) is a rare, congenital neurocutaneous syndrome. We rarely experienced neurocutaneous disorders in forensic practice but there are unexpected sudden deaths of patients with SWS due to epilepsy, intracranial hemorrhage, thromboses and secondary accident. We introduce a case of drowning death probably due to an epileptic attack of a person diagnosed as a patient of SWS by an autopsy. We review some of the neurocutaneous syndromes and a discussion of autopsy approach is presented.

Xanthogranulomatous Cholecystitis Not Associated with Gallstone in a 9-year-old Girl

Xanthogranulomatous cholecystitis (XGC) is known to be a rare, variant type of chronic cholecystitis and more frequently found in the adults with a prevalence of 0.7 to 13.2% of all cholecystitis, moreover very rare in children. Clinically, this usually presents as chronic or acute cholecystitis associated with gallstones, but biliary colic is unusual. Although it requires surgery for management, it may accompany some difficulties during cholecystectomy and postoperative complications such as biliary fistula. It could also give rise to higher conversion rates than other diseases of the gallbladder during laparoscopic procedures. We experienced a very rare pediatric case of xanthogranulomatous cholecystitis not associated with gallstones, successfully managed by laparoscopic cholecystectomy and hereby report it with literature reviews.

Operative Treatment for Cardiac Tamponade with Ventricular Rupture of PostMyocardial Infarction without Cardiopulmonary Bypass: A case report / 대한흉부외과학회지

Ischemic ventricular rupture is one of the most fatal complications following myocardial infarction, and this requires prompt diagnosis and operation. A 75-year-old female was admitted to the ER in a semicomatous mentality with cyanotic extremities. Cardiac echography was carried out in the ER, and a 1.5~2 cm thickness of effusion in the pericardium was seen. Because the patient's heart had declined to 35 times per min, an emergency operation was started while giving cardiac massage. After observing a 1 cm rupture on the right ventricular wall and a necrotic hemorrhagic scar with a rupture on the left ventricular apical wall, repair of the ruptured areas with a large Satinsky clamp was carried out to control bleeding without cardiopulmonary bypass. On the 28th day after surgery, she was discharged home with a minimal degree of dyspnea.