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"Praktek kerja profesi di Badan Pengawas Obat dan Makan Republik Indonesia Periode Maret 2018 bertujuan untuk memperoleh pengetahuan tentang organisasi, tugas dan fungsi Badan POM khususnya di Direktorat Registrasi Obat. Praktik kerja profesi juga bertujuan untuk memberikan pemahaman terhadap calon apoteker terhadap peranan, tugas dan tanggung-jawab apoteker di Badan POM serta ketrampilan dan pengalaman praktis dalam pelaksanaannya. Praktik kerja profesi juga memberikan gambaran terhadap calon apoteker tentang gambaran nyata permasalahan kefarmasian di Badan POM. Praktik kerja profesi dilakukan selama satu bulan dengan tugas khusus yaitu ldquo;Kajian Status Bioekivalensi Tamoxifen rdquo; yang bertujuan untuk mengetahui apakah Tamoxifen perlu dimasukan ke dalam daftar obat yang wajib melakukan bioekivalensi. Tugas khusus dilakukan dengan mengumpulkan referensi mengenai Tamoxifen dan kemudian menganalisis referensi tersebut terhadap peraturan-peratuan bioekivalensi yang berlaku.

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Internship at di Badan Pengawas Obat dan Makan Republik Indonesia Period March 2018 aims to understand about organization, task, and function of Badan POM, especially in Direktorat Registrasi Obat. Internship also aims to give understanding for apotechary candidate about the roles, tasks, and responsibilities of apothecary in Badan POM, also skils and experiences to do it. Internship also gives apotechary candidate an insight of real problems in Badan POM. Internship was conducted for one month with special assignment ldquo;Review on Bioequivalency Status of Tamoxifen rdquo; that aims to know whether Tamoxifen needs to be included on list of drug that required to do bioequivalence bioequivalence test or not. Special assignment was conducted by collecting references about Tamoxifen and then analyse them based on regulations about bioquivalence."

"Profesi Apoteker memegang beragam peranan penting di Badan Pengawas Obat dan Makanan (POM) sebagai salah satu lembaga pemerintah melalui implementasi ilmu kefarmasian dan non-kefarmasian yang dimiliki dalam rangka pengembangan kompetensi yang harus dimiliki oleh profesi Apoteker. Kajian pengawasan obat dan makanan merupakan suatu proses pengawasan yang menyeluruh dari proses hulu hingga proses hilir, yang mencakup pengawasan premarket dan post market yang seluruhnya ditujukan untuk melindungi masyarakat dari peredaran produk yang sub-standar. Direktorat Standardisasi Produk Terapetik (PT) dan Perbekalan Kesehatan Rumah Tangga (PKRT) berperan dalam pengawasan pre-market yakni melalui pemberian layanan bimbingan industri farmasi, penyusunan standar, pedoman, dan regulasi terkait produk terapetik dan PKRT, serta penilaian dan evaluasi laporan dan protokol uji Bioekivalensi (BE) terhadap produk obat tertentu sebagai bagian persyaratan registrasi obat.

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Pharmacist hold a variety of important roles in Indonesia Food and Drug Regulatory Agency Badan POM as one of the government agencies through the implementation of the science of pharmacy and non pharmacy owned in order to develop competencies that should be possessed by the pharmacist profession Study of drug and food control is a process of thorough scrutiny of the upstream and downstream processes which includes pre market monitoring and post market surveillance which are all aimed to protect public from sub standard products Standardization Directorate of Threapeutics Products and Household Health plays a role in pre market monitoring through the provision of guidance to pharmaceutical industry preparation of standards guidelines and regulations related to therapeutic products and household health as well as assessment and evaluation reports and bioequivalence test protocols against certain drug products as part of drug registration requirements."

"ABSTRAKPraktek Kerja Profesi Apoteker di Badan Pengawas obat dan Makanan bertujuan untuk calon apoteker mampu memahami tugas dan tanggung jawab apoteker dalam lembaga pemerintahan, memberikan gambaran nyata tentang permasalahan pekerjaan kefarmasiaan di lembaga pemerintahan. Tugas khusus yang diberikan berjudul Pengkajian Penerapan Fast Track Registrasi Orphan Drugs di Indonesia . Tujuan dari tugas khusus ini adalah untuk mengetahui kekurangan dan kelebihan penerapan fast track di Indonesia

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ABSTRAKProfession Internship at Indonesia National Agency of drug and Food Control aiming for that prospective pharmacists are able to understand the duties and responsibilities of pharmacists in the government agencies, and have a real picture of the issues pharmaceutical practice and learn the strategies and activities that can be done in the framework of the development of pharmacy practice. Given the special task entitled Assessment Implementation Fast track registration of orphan drugs in Indonesian. The purpose of this special task is to know the advantages and disadvantages of the implementation of the fast track in Indonesia."

"[Kegiatan PKP (Praktek Kerja Profesi) dilaksanakan di Badan Pengawas Obat dan Makanan memiliki tujuan memahami peranan, tugas, dan tanggung jawab apoteker di instasi pemerintahan, menambah pengalaman praktis mengenai pekerjaan kefarmasian di Badan POM, serta memiliki gambaran nyata mengenai masalah kefarmasian di instansi pemerintah. Praktek kerja dilaksanakan di salah satu unit penunjang Badan POM yaitu Pusat Riset Obat dan Makanan (PROM). Mahasiswa melakukan pengkajian dokumen untuk meningkatkan mutu instansi dan kinerja dari personel. Mahasiswa juga melakukan verifikasi terhadap metode uji bahan tambahan pangan berbahaya dalam produk pangan yaitu, formalin dan rhodamin b . Tugas khusus yang diberikan adalah melakukan pengkajian terhadap riset penggunaan polimer nanokomposit biodegradable sebagai bahan kemasan pangan yang ramah lingkungan. Berdasarkan pengkajian riset tersebut dapat dibuktikan bahwa modifikasi antara polimer sintetik dan polimer alam dapat mempercepat degradasi polimer sehingga dapat mengatasi masalah pencemaran lingkungan.Apothecary Internship Program at the Food and Drug Administration (Badan POM) had the goal to understanding the role and responsibilities of pharmacists in government, gain experience about pharmacy jobs in Badan POM, and has a real picture of the pharmaceutical problem in government agencies. Apothecary internship program carried out in one of the supporting section in Badan POM namely Research Centre for Drugs and Food (PROM). Students had given task to review the documents to improve the quality performance of personnel agencies. Students also conducted verification of the identification method food additives in food products, for example to identification formalin and rhodamine b. Student had Given the special task is to reviewed a research study on the use of biodegradable polymer nanocomposite as a food packaging material. Based on these research studies can be proven that the modifications between synthetic polymers and natural polymers can accelerate the degradation of the polymer so as to overcome the problem of environmental pollution.; ABSTRACT Name Carmelita Dissa Wardhani NPM 1406525016 Study Program Apothecary Title Apothecary Internship Program at Badan Pengawas Obat dan Makanan March 2015 Apothecary Internship Program at the Food and Drug Administration Badan POM had the goal to understanding the role and responsibilities of pharmacists in government gain experience about pharmacy jobs in Badan POM and has a real picture of the pharmaceutical problem in government agencies Apothecary internship program carried out in one of the supporting section in Badan POM namely Research Centre for Drugs and Food PROM Students had given task to review the documents to improve the quality performance of personnel agencies Students also conducted verification of the identification method food additives in food products for example to identification formalin and rhodamine b Student had Given the special task is to reviewed a research study on the use of biodegradable polymer nanocomposite as a food packaging material Based on these research studies can be proven that the modifications between synthetic polymers and natural polymers can accelerate the degradation of the polymer so as to overcome the problem of environmental pollution ; ABSTRACT Name Carmelita Dissa Wardhani NPM 1406525016 Study Program Apothecary Title Apothecary Internship Program at Badan Pengawas Obat dan Makanan March 2015 Apothecary Internship Program at the Food and Drug Administration Badan POM had the goal to understanding the role and responsibilities of pharmacists in government gain experience about pharmacy jobs in Badan POM and has a real picture of the pharmaceutical problem in government agencies Apothecary internship program carried out in one of the supporting section in Badan POM namely Research Centre for Drugs and Food PROM Students had given task to review the documents to improve the quality performance of personnel agencies Students also conducted verification of the identification method food additives in food products for example to identification formalin and rhodamine b Student had Given the special task is to reviewed a research study on the use of biodegradable polymer nanocomposite as a food packaging material Based on these research studies can be proven that the modifications between synthetic polymers and natural polymers can accelerate the degradation of the polymer so as to overcome the problem of environmental pollution , ABSTRACT Name Carmelita Dissa Wardhani NPM 1406525016 Study Program Apothecary Title Apothecary Internship Program at Badan Pengawas Obat dan Makanan March 2015 Apothecary Internship Program at the Food and Drug Administration Badan POM had the goal to understanding the role and responsibilities of pharmacists in government gain experience about pharmacy jobs in Badan POM and has a real picture of the pharmaceutical problem in government agencies Apothecary internship program carried out in one of the supporting section in Badan POM namely Research Centre for Drugs and Food PROM Students had given task to review the documents to improve the quality performance of personnel agencies Students also conducted verification of the identification method food additives in food products for example to identification formalin and rhodamine b Student had Given the special task is to reviewed a research study on the use of biodegradable polymer nanocomposite as a food packaging material Based on these research studies can be proven that the modifications between synthetic polymers and natural polymers can accelerate the degradation of the polymer so as to overcome the problem of environmental pollution ]"

"Praktek Kerja Profesi (PKP) di pemerintahan bertempat di Badan Pengawas Obat dan Makanan Jakarta Pusat. Khususnya di Direktorat Pengawasan Narkotika, Psikotropika dan Zat Adiktif. Kegiatan ini berlangsung selama tiga minggu dari tanggal 8 sampai dengan tanggal 30 September 2015. PKP di BPOM bertujuan agar mahasiswa apoteker mengerti tugas dan tanggung jawab apoteker, memiliki pengetahuan tentang tugas pokok dan fungsi BPOM, memiliki wawasan, pengetahuan, keterampilan dan pengalaman praktis melakukan pekerjaan di BPOM serta memiliki gambaran nyata akan permasalahan pekerjaan kefarmasian di BPOM. Berdasarkan kegiatan PKP yang dilakukan, Apoteker bertanggung jawab penuh atas seluruh kegiatan pengawasan obat dan makanan. Mahasiswa apoteker telah memiliki pengetahuan dan pengalaman mengenai proses inspeksi, sertifikasi dan pengaturan. Berdasarkan pengamatan selama pelaksanaan PKP masalah yang terjadi di BPOM khususnya di Direktorat Pengawasan Narkotika, Psikotropika dan Zat Adiktif salah satunya kurang responnya Dinas Kesehatan Provinsi atau Kabupaten/Kota terhadap Rekomendasi Tindak Lanjut Hasil Pengawasan yang dikirimkan Direktorat Pengawasan Narkotika, Psikotropika dan Zat Adiktif.

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Profession Internship at government at Badan Pengawas Obat dan Makanan, Jakarta Pusat especially at Direktorat Pengawasan Narkotika, Psikotropika dan Zat Adiktif. This activity was held for three weeks from September 8th until September 30th 2015. Profession Internship at BPOM aims to make apothecary student understand the duties and responsibilities of pharmacists, have knowledge of the basic tasks and functions of BPOM, insight, knowledge, skills and practical experience doing work in BPOM and have a real picture of the issues of pharmacy jobs in BPOM. Based on the activities, Pharmacists are fully responsible for all activities of drug and food control. Student pharmacists already have the knowledge and experience of the inspection, certification and regulation. Based on observations during the implementation of the PKP the problems that occur in BPOM especially in the Directorate of narcotics, psychotropic and addictive substances one less response to the Provincial Health Office or District / Town on Oversight Recommendations Follow-up results are sent Directorate of narcotics, psychotropic and addictive substances."

"Apoteker merupakan profesi tenaga kesehatan yang berperan dalam pelayanan kesehatan dan produksi obat. Untuk bidang pelayanan kesehatan, seorang apoteker dapat menjalankan perannya di fasilitas kesehatan seperti apotek dan rumah sakit. Untuk produksi obat, seorang apoteker dapat menjalankan perannya di fasilitas produksi farmasi seperti industri farmasi. Selain sektor produksi dan pelayanan, apoteker juga memiliki peran dalam regulasi obat yang beredar di Indonesia. Untuk menciptakan seorang apoteker yang profesional dalam melakukan pekerjaannya, salah satu hal penting untuk dilakukan adalah pelatihan dengan cara berpartisipasi langsung dalam melaksanakan pekerjaan kefarmasian melalui Praktik Kerja Profesi Apoteker (PKPA). Praktik Kerja Profesi Apoteker (PKPA) dilakukan sebagai persiapan calon apoteker dalam melaksanakan tugas dan perannya baik di sector pelayanan, produksi obat farmasi, maupun regulasi obat di Indonesia. Praktik Kerja Profesi Apoteker dilaksanakan di Rumah Sakit Universitas Indonesia selama periode Januari – Maret 2021, di Badan Pengawas Obat dan Makanan Republik Indonesia pada periode Maret 2021 dan di Apotek Atrika selama periode April 2021. Melalui program Praktik Kerja Profesi Apoteker (PKPA) diharapkan calon apoteker mendapat gambaran peran apoteker di dunia kerja dan dapat menambah wawasan, keterampilan, serta pengalaman calon apoteker.

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Pharmacists are health professionals who play a role in health services and drug production. In the field of health services, a pharmacist can carry out his role in health facilities such as pharmacies and hospitals. For drug production, a pharmacist can carry out his role in pharmaceutical production facilities such as the pharmaceutical industry. In addition to the production and service sectors, pharmacists also have a role in the regulation of drugs circulating in Indonesia. To create a pharmacist who is professional in doing his job, one of the important things to do is training by participating directly in carrying out pharmaceutical work through the Pharmacist Professional Work Practice (PKPA). The Pharmacist Professional Work Practice (PKPA) is carried out as a preparation for prospective pharmacists in carrying out their duties and roles both in the service sector, pharmaceutical drug production, and drug regulation in Indonesia. The Pharmacist Professional Work Practice is held at the University of Indonesia Hospital during the period January – March 2021, at the Food and Drug Supervisory Agency of the Republic of Indonesia in the March 2021 period and at the Atrika Pharmacy during the April 2021 period. Through the Pharmacist Professional Work Practice (PKPA) program, it is hoped that prospective pharmacists will get an overview of the role of pharmacists in the world of work and can add insight, skills, and experience to prospective pharmacists."

"[ABSTRAKBadan Pengawas Obat dan Makanan (BPOM) merupakan Lembaga Pemerintah Non Kementerian (LPNK) yang bertanggung jawab kepada Presiden dan melaksanakan tugas pemerintahan di bidang pengawasan Obat dan Makanan sesuai dengan ketentuan peraturan Perundang-Undangan yang berlaku. Kegiatan praktik kerja di Badan Pengawas Obat dan Makanan bertujuan agar calon apoteker : mampu memahami peranan, tugas, dan tanggung jawab apoteker di Badan Pengawas Obat dan Makanan; memiliki pengetahuan tentang tugas pokok dan fungsi Badan Pengawas Obat dan Makanan di bidang farmasi; memiliki wawasan, pengetahuan, keterampilan, dan pengalaman praktis melakukan pekerjaan di Badan Pengawas Obat dan Makanan; memiliki gambaran nyata tentang permasalahan kefarmasian di Badan Pengawas Obat dan Makanan. Mengingat bahwa penyalahgunaan narkotika, psikotropika, dan zat adiktif merupakan tantangan terutama bagi generasi muda di Indonesia, salah satu direktorat di Badan Pengawas Obat dan Makanan (BPOM) yaitu Direktorat Pengawasan NAPZA (Narkotik, Psikotropik, dan Zat Adiktif) bertugas melaksanakan kegiatan pengawasan terhadap Narkotika, Psikotropika, Prekursor, dan Rokok secara komprehensif dari hulu ke hilir. Selain itu, Direktorat Pengawasan NAPZA juga melakukan pengawasan terkait rokok, termasuk produk rokok dan iklan rokok.

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ABSTRACTNational Agency of Drug and Food Control is a Non-Government Organization that is responsible to the President and carry out government duties in the field of Food and Drug supervision in accordance with the provisions of the applicable Legislation. Activity in the working practices of Food and Drug Supervisory Agency aims to prospective pharmacists: able to understand the role, duties and responsibilities of pharmacists in the Food and Drug Administration; have knowledge of basic tasks and functions of the Food and Drug Administration in the field of pharmacy; has the insight, knowledge, skills, and practical experience doing the job at the Food and Drug Administration; have knowledge about the problems of pharmacy at the Food and Drug Supervisory Agency. Given that the abuse of narcotics, psychotropic and addictive substances is a challenge, especially for the younger generation in Indonesia, one of the directorates in the National Agency of Drug and Food Control, namely the Directorate of Drugs (Narcotics, Psychotropic and Addictive Substances) in charge of conducting surveillance of Narcotics , Psychotropic Substances, Precursors, and Cigarettes comprehensively from upstream to downstream. In addition, the Directorate of Drug Control also monitors related to cigarettes, including cigarettes and cigarette advertising products.;National Agency of Drug and Food Control is a Non-Government Organization that is responsible to the President and carry out government duties in the field of Food and Drug supervision in accordance with the provisions of the applicable Legislation. Activity in the working practices of Food and Drug Supervisory Agency aims to prospective pharmacists: able to understand the role, duties and responsibilities of pharmacists in the Food and Drug Administration; have knowledge of basic tasks and functions of the Food and Drug Administration in the field of pharmacy; has the insight, knowledge, skills, and practical experience doing the job at the Food and Drug Administration; have knowledge about the problems of pharmacy at the Food and Drug Supervisory Agency. Given that the abuse of narcotics, psychotropic and addictive substances is a challenge, especially for the younger generation in Indonesia, one of the directorates in the National Agency of Drug and Food Control, namely the Directorate of Drugs (Narcotics, Psychotropic and Addictive Substances) in charge of conducting surveillance of Narcotics , Psychotropic Substances, Precursors, and Cigarettes comprehensively from upstream to downstream. In addition, the Directorate of Drug Control also monitors related to cigarettes, including cigarettes and cigarette advertising products., National Agency of Drug and Food Control is a Non-Government Organization that is responsible to the President and carry out government duties in the field of Food and Drug supervision in accordance with the provisions of the applicable Legislation. Activity in the working practices of Food and Drug Supervisory Agency aims to prospective pharmacists: able to understand the role, duties and responsibilities of pharmacists in the Food and Drug Administration; have knowledge of basic tasks and functions of the Food and Drug Administration in the field of pharmacy; has the insight, knowledge, skills, and practical experience doing the job at the Food and Drug Administration; have knowledge about the problems of pharmacy at the Food and Drug Supervisory Agency. Given that the abuse of narcotics, psychotropic and addictive substances is a challenge, especially for the younger generation in Indonesia, one of the directorates in the National Agency of Drug and Food Control, namely the Directorate of Drugs (Narcotics, Psychotropic and Addictive Substances) in charge of conducting surveillance of Narcotics , Psychotropic Substances, Precursors, and Cigarettes comprehensively from upstream to downstream. In addition, the Directorate of Drug Control also monitors related to cigarettes, including cigarettes and cigarette advertising products.]"

"ABSTRAKIndonesia harus memiliki sistem pengawasan obat dan makanan yang efektif dan efisien yang mampu mendeteksi, mencegah dan mengawasi produk termaksud untuk melindungi keamanan, keselamatan dan kesehatan masyarakat. Untuk itu dibentuk Badan POM yang memiliki jaringan serta kewenangan penegakan hukum dan memiliki kredibilitas profesional yang tinggi. Praktek Kerja Profesi yang dilaksanakan di Badan POM bertujuan untuk memahami tugas, fungsi, serta ruang lingkup kegiatan dari institusi pemerintah di bidang pengawasan obat dan makanan, khususnya di Direktorat Pengawasan Distribusi Produk Terapetik dan Perbekalan Kesehatan Rumah Tangga. Dengan demikian calon Apoteker dapat memiliki pengetahuan, keterampilan, dan pengalaman nyata mengenai pekerjaan pemerintahan di Badan POM.

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ABSTRACT Indonesia should have an effective and efficient drug and food control system with capability to detect, prevent and control such products in order to protect the consumers security and health. Therefore, National Agency of Drug and Food Control is established with a networking, authority to conduct law enforcement and highly credible professionalism. The internship at NA-DFC was aimed to understand the duties, functions, and roles of NA-DFC, specifically at Direktorat Pengawasan Distribusi Produk Terapetik dan Perbekalan Kesehatan Rumah Tangga. Therefore, the pharmacist would have extensive knowlege, insight, and good practical experience of NA-DFC. "