Asia Partnership Conference of Pharmaceutical Associations (APAC) Report on Regulatory Agility Implemented During the COVID-19 Pandemic: Inspiring Partnerships and Recommendations for the Way Forward.

PURPOSE: Asia Partnership Conference of Pharmaceutical Associations (APAC) promote regulatory agility of four important best practices i.e. reliance, digital platform, accepting electronic document and process integration. Dialogues and strong partnership witnessed reforms and efficiencies amidst the pandemic. In tracking the progress of regulatory agility, APAC identifies areas for improvement and recommends prioritizing these areas for change. METHODS: As one voice, 13 main industry associations under the umbrella of APAC sent joint letters to our National Regulatory Authorities (NRAs) with a call to maintain regulatory agility and consider new ways of working. Consequently, APAC surveyed its member associations to measure regulatory agilities implemented by the NRAs during 2020 and 2021 in view of the pandemic. RESULTS: This paper reports progress in implementing regulatory agility, e.g. the number of economies that can accept electronic Certificate of Pharmaceutical Products (eCPP) has reached 100% for the economies that require CPP and more than 90% can waive onsite inspection in the presence of Good Manufacturing Practice (GMP) certificate and/or inspection report. The paper also features the progress made in Malaysia, the Philippines, and the ASEAN (Association of South East Asian Nations) regional reliance initiative to reduce inefficiencies and duplications. CONCLUSIONS: We have demonstrated the power of working together to enable regulatory agilities and efficiencies. APAC will continue to track the progress of all economies including India within the areas for improvement prioritized and discussed in this paper. APAC is also committed to working with key stakeholders including our NRAs in Asia to sustain and enable a new era of innovation ushered in by COVID-19 to benefit patients.

Characteristics of Upper-Limb Pull Power and Power Endurance in Japanese Female Wrestlers.

ABSTRACT: Naka, T, Kanno, M, Shidochi, S, Sakae, K, and Shima, N. Characteristics of upper-limb pull power and power endurance in Japanese female wrestlers. J Strength Cond Res 36(5): e82-e87, 2022-This study aimed at elucidating the characteristics of upper-limb physical strength required by female wrestlers by comparing the pull power, power endurance, and number of repetitions between female wrestlers at world and national levels. The subjects were 20 female wrestlers (8 Olympic- and/or world-class and 12 national-class top-ranking individuals). The subjects assumed a lying prone (face down) position on a bench and pulled a bar from arms length until contact with underside of bench. The weight load was increased in 10-kg steps and the upper-limb pull power was measured for each lift. To measure power endurance, the power to achieve the repetition maximum and the maximum number of repetitions were measured at the load at which they exerted their maximum power. All measurements were obtained using a GymAware power meter (Kinetic Performance Technology, Canberra, Australia). Pull power was greater at 20, 30, 40, and 50 kg in world-class wrestlers than in national-class wrestlers. No difference was observed in the time course of power endurance between the groups; however, the power in world-class wrestlers declined slower than in national-class wrestlers. Repetition maximum also tended to be higher in world-class wrestlers than in national-class wrestlers. Female wrestlers were observed to have greater upper-limb pull power in a range from low to high loads and were able to preserve repetition ability while maintaining high power. Their competitive performance seems to be related to these abilities.

[Ectopic mediastinal parathyroid adenoma].

We experienced 3 surgical cases with ectopic mediastinal parathyroid adenoma. All patients checked elevated serum calcium levels and parathyroid hormone levels above normal range so we diagnosed their illness as primary hyperparathyroidism. Two had treated urinary tract lithiasis for long time, and the other had no symptoms by hypercalcemia. To determine the location of abnormal parathyroid glands, 99mTc-methoxy-isobutyl-isonitrile (MIBI) scintigraphy, chest computed tomography (CT) scan and/or magnetic resonance imaging (MRI) were done, then posterior and anterior mediastinal tumors were revealed. Especially MIBI scintigraphy was very useful as diagnostic procedure for small ectopic parathyroid adenoma. It's considered that large tumor in the posterior mediastinum like case 1 is originated from upper parathyroid gland, and small tumor in the anterior mediastinum like case 2, 3 is originated from lower parathyroid gland. Tumors were resected via small thoracotomy with thoracoscope, cervical incision and partial median sternotomy respectively. Serum calcium and parathyroid hormone levels were normalized immediately. If we can detect the accurate location of small ectopic parathyroid adenoma using some intraoperative method, the tumor is resected by less invasive procedure.

Rupture of infectious aneurysm of the thoracic aorta into the lung after radical esophageal cancer surgery.

A 60-year-old male underwent radical operation for esophageal cancer 45 days prior to complaining of several incidents of hemoptysis. The hemoptysis was found to be caused by infectious aneurysm of the descending thoracic aorta penetrating the lung. The aneurysm was resected and the aortic wall was sutured directly under percutaneous circulatory pulmonary support system. The sutured thoracic aorta was wrapped with the pedicle of an intercostal muscle flap to prevent reinfection. Forty-eight days after the aortic wall suture operation, however, the patient experienced massive hemoptysis and went into shock. Angiography was reveal no arterial lesions, so emergency left lower lobectomy was performed on suspicion of lung vessel rupture. Immediately after the lower lobectomy, recurrence of the aortic wall rupture caused uncontrollable bleeding. The patient died intraoperatively.

Clinical effects of percutaneous cardiopulmonary support in severe heart failure: early results and analysis of complications.

Between January 1993 and December 2001, we employed percutaneous cardiopulmonary support (PCPS) in 35 patients. PCPS was used for postcardiotomy in 25 of these patients who could not be weaned from cardiopulmonary bypass (CPB) because of severe cardiogenic shock. In the other 10 patients, PCPS was used for a non-surgical disease. Twenty-nine patients (82.9%) were weaned from PCPS, and 28 (80.0%) survived. The other 7 patients (20.0%) died due to postoperative complications. The causes of death were multiple organ failure (MOF) due to wound bleeding, low cardiac output syndrome (LOS), myonephropathic metabolic syndrome (MNMS) with severe lower limbs ischemia, cerebrovascular accident (CVA), and sepsis. The first cause for the complications was postoperative sustained severe heart failure. To improve the survival rate, it was necessary to prevent bleeding and begin PCPS at an earlier stage.