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"This book guides the reader through FDA regulation guidelines and outlines a comprehensive strategy for cost reduction in regulatory affairs and compliance. This book explains six strategies to cost-effectively comply with FDA regulations while maintaining product safety and improving public access through cost controls. It provides useful and practical guidance through industry case studies from pharmaceutical, biotech, and medical device industries."

"Biofilm Eradication and Preventions presents the basics of biofilm formation on medical devices, diseases related to this formation, and approaches pharmaceutical researchers need to take to limit this problem. Split into three parts, the first deals with the development and characterization of biofilm on the surfaces of implanted or inserted medical devices. Questions as to why biofilms form over medical device surfaces and what triggers biofilm formation are addressed. In the second section, the author discusses biofilm-mediated chronic infections occurred in various organs (eyes, mouth, wounds) and pharmaceutical and drug delivery knowledge gained from research in these area. The third part explores pharmaceutical approaches like lipid-and polymer-based drug delivery carriers for eradicating biofilm on device-related infections. In addition, this section also explores the topic of novel small molecule (like iron and its complexes/metal chelators) and a quorum-sensing inhibitors to control medical biofilm formation."

"Persaingan yang ketat mendorong perusahaan untuk membangun manajemen hubungan pelanggan yang kuat untuk mempertahankan loyalitas pelanggan. Penggalian informasi terkait dengan customer lifetime value (CLV) mendukung perusahaan untuk memperlakukan setiap pelanggan secara berbeda berdasarkan kontribusi pelanggan terhadap keuntungan perusahaan. Penelitian ini bertujuan untuk mengidentifikasi karakteristik dan nilai dari masing-masing kelompok pelanggan berdasarkan customer lifetime value menggunakan model length, recency, frequency, dan monetary (LRFM), sehingga memberikan wawasan bagi perusahaan untuk menghasilkan strategi retensi pelanggan yang sesuai. Dalam studi ini, CLV dievaluasi di perusahaan distribusi farmasi dan alat Kesehatan di Indonesia. Pertama, algoritma k-means diterapkan untuk melakukan klasterisasi pelanggan. Terdapat delapan klaster yang terbentuk dalam penelitian ini. Selanjutnya, metode analytic hierarchy process (AHP) digunakan untuk mendapatkan informasi terkait dengan bobot kepentingan model LRFM. Hasil perhitungan AHP menunjukkan bahwa frekuensi adalah variabel yang paling penting di sektor ini. Selanjutnya, CLV dihitung dan diberi peringkat untuk delapan klaster optimal yang dihasilkan. Hasil penelitian menunjukkan bahwa klaster 3, klaster 6, dan klaster 8 adalah pelanggan yang paling bernilai bagi perusahaan. Pada tahap akhir, dilakukan penentuan jenis strategi retensi yang sesuai terhadap klaster yang terbentuk.

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Dealing with intense competition encourages companies to build strong customer relationship management to maintain customer loyalty. Extracting information related to customer lifetime value (CLV) supports the company to treat each customer differently based on their contribution to the company profits. This study aims to identify the characteristics and values of each customer group based on customer lifetime value using the length, recency, frequency, and monetary (LRFM) model, hence providing insights for the company to generate suitable customer retention strategies. In this study, CLV is evaluated at the pharmaceutical and medical device distribution company in Indonesia. First, k-means algorithm was applied to cluster customers. There are eight clusters formed in this study. Subsequently, the analytic hierarchy process (AHP) method was used to gain information related to the weight of importance of LRFM model. AHP results demonstrated that frequency is the most important variable in this sector. CLV was finally calculated and ranked for the resulting eight optimum clusters. The results showed that cluster 3, cluster 6, and cluster 8 were the most valuable customers for the company. Appropriate retention strategies were also determined for the clusters formed."

"Praktek Profesi Apoteker di Direktorat Jenderal Kefarmasian dan Alat Kesehatan Kementerian Kesehatan Republik Indonesia bertujuan untuk memahami peranan, tugas, dan tanggung jawab apoteker di Direktorat Jenderal Kefarmasian dan Alat Kesehatan, khususnya Direktorat Pengawasan Alat Kesehatan dan Perbekalan Kesehatan Rumah Tangga PKRT , memiliki pengetahuan tentang tugas pokok dan fungsi Direktorat Jenderal Kefarmasian dan Alat Kesehatan khususnya Direktorat Pengawasan Alat Kesehatan dan PKRT di bidang farmasi, memiliki wawasan, pengetahuan, keterampilan dan pengalaman praktis melakukan pekerjaan di Direktorat Jenderal Kefarmasian dan Alat Kesehatan khususnya Direktorat Pengawasan Alat Kesehatan dan PKRT, serta memiliki gambaran nyata tentang permasalahan kefarmasian di Direktorat Jenderal Kefarmasian dan Alat Kesehatan khusunya Direktorat Pengawasan Alat Kesehatan dan PKRT. Praktek kerja profesi dilakukan selama dua minggu di Direktorat Pengawasan Alat Kesehatan dan PKRT. Pada pelaksanaan praktek kerja terdapat tugas khusus berupa Kodefikasi Produk Alat Kesehatan di Provinsi Yogyakarta

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Apoteker Internship at the Directorate General of Pharmaceutical and Medical Devices Ministry Republic of Indonesia aims to understand the role, duties and responsibilities of pharmacists in the Directorate General of Pharmaceutical and Medical Devices, especially the Directorate of Medical Devices and Household Health Supplies PKRT The main duties and functions of the Directorate General of Pharmaceutical and Medical Devices, especially the Directorate of Medical Devices and PKRT in the field of pharmacy, have insight, knowledge, skills and practical experience of performing work in the Directorate General of Pharmaceutical and Medical Devices, especially the Directorate of Medical Device Monitoring and PKRT, Real on pharmaceutical issues in the Directorate General of Pharmaceutical and Medical Devices especially the Directorate of Medical Device Monitoring and PKRT. The professional work practice is conducted for two weeks at the Directorate of Medical Device Monitoring and PKRT. In the implementation of work practices there is a special task in the form of Health Product Product Code in Yogyakarta Province "

"This book offers comprehensive, easy to understand guidance for medical device technology innovators on how to work through the United States FDA regulatory review process, while also providing insight on the various intellectual property concerns that many medical device innovators face. In the first portion of this book, readers are introduced to important concepts concerning FDA compliance for medical devices, as well as strategies for successfully navigating the FDA regulatory review process. Specifically, the first portion discusses the expansive range of medical devices and then walks through the most common routes to market: the PMA and 510(k) application processes. In the second portion of this book, readers are introduced to the various types of intellectual property rights that are available for medical device technology inventions and innovations, and can explore ways to overcome unique intellectual property challenges faced by many medical device technology innovators. In the third portion of the book, specific strategies are discussed to navigate the interface between the FDA regulatory process and the process of obtaining intellectual property protection.This book also includes a number of descriptive examples, case studies and scenarios to illustrate the topics discussed, and is intended for use by medical device designers, developers and innovators."

"Peningkatan pelayanan kesehatan selalu diupayakan oleh Pemerintah mengingat semakin berkembangnya ilmu pengetahuan dan teknologi dalam dunia kesehatan. Upaya untuk meningkatkan pelayanan kesehatan dapat melalui pelayanan kefarmasian yang professional. Apoteker memiliki peran dan tanggung jawab dalam mendukung tercapainya sasaran program kesehatan, terutama dibidang kefarmasian. Melalui kegiatan Praktek Kerja Profesi Apoteker PKPA ini diharapkan calon apoteker dapat lebih memahami peran dan tugas Apoteker dalam melakukan pekerjaan kefarmasian di Direktorat Jenderal Kefarmasian dan Alat Kesehatan Kementerian Kesehatan Republik Indonesia, khususnya Direktorat Produksi dan Distribusi Kefarmasian. Praktek kerja profesi ini dilaksanakan mulai dari tanggal 22 Mei ndash; 2 Juni 2017. Berdasarkan PKPA yang telah dilakukan, Direktorat Produksi dan Distribusi Kefarmasian merupakan tempat bagi seorang apoteker untuk dapat menjalankan profesi apoteker yang berkaitan dengan kepentingan perikemanusiaan terutama dalam bidang kesehatan. Apoteker di lingkup pemerintahan, khususnya Direktorat Produksi dan Distribusi Kefarmasian dapat memberikan perannya di bidang regulasi, penyusunan norma, standar, prosedur dan kriteria, serta pemberian bimbingan yang berkaitan dengan produk dan distribusi produk farmasi, kosmetika dan makanan.

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Improving health services is always strived by the government given the growing development of science and technology in the world of health. Efforts to improve health services can be through professional pharmaceutical services. Pharmacists have a role and responsibility in supporting the achievement of health program targets, especially in the field of pharmaceuticals. Through this internship activity, the pharmacist candidate can better understand the role and duty of pharmacist in performing pharmaceutical work in Directorate General of Pharmaceutical and Medical Device Ministry of Health of the Republic of Indonesia, especially the Directorate of Pharmaceutical Production and Distribution. This internship is carried out from May 22nd to June 2nd, 2017. Based on internship that has been done, the Directorate of Pharmaceutical Production and Distribution is a place for a pharmacist to be able to run the pharmacist profession related to the interests of humanity, especially in the field of health. Pharmacists in the scope of government, especially the Directorate of Pharmaceutical Production and Distribution can provide its role in the field of regulation, compilation of norms, standards, procedures and criteria, as well as providing guidance related to the product and distribution of pharmaceutical products, cosmetics and foods."

"This book describes the way that pharmaceutical projects and programs are currently managed, and offers views from many highly experienced practitioners from within the industry on future directions for drug program management. The book integrates portfolio, program, and project management processes as fundamental for effective and efficient drug product development. Contributing expert authors provide their view of how the projectization approach can be taken forward by the drug industry over the coming years."