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Abstrak :
ABSTRAK
Praktik Kerja Profesi Apoteker PKPA di PT Johnson Johnson Indonesia bertujuan untuk memahami peranan apoteker di industri salah satunya mengenai lingkup kerja, tugas, dan peran seorang regulatory officer. Regulatory officer bertugas untuk mendaftarkan produk ke Badan POM. Obat yang beredar di Indonesia wajib dilakukan registrasi untuk melindungi konsumen dan menjamin mutu dan keamanan obat. Oleh sebab itu penting bagi apoteker untuk mengetahui dan menjalani praktik kerja di bidang registrasi obat.

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ABSTRACT
Internship at PT Johnson Johnson Indonesia aims to understand the role of pharmacists in the industry, one of which concerns the scope of work, duties, and the role of a regulatory officer. Regulatory officer is the person that responsibility to register the product to regulator BPOM . Drugs circulating in Indonesia must be registered to protect consumers and ensure the quality and safety of drugs. Therefore it is important for pharmacists to know and practice of working in the field of drug registration.

Abstrak :
ABSTRAK
Praktik Kerja Profesi Apoteker PKPA di PT Johnson Johnson Indonesia bertujuan untuk memahami peranan apoteker di industri salah satunya mengenai lingkup kerja, tugas, dan peran seorang regulatory officer. Regulatory officer bertugas untuk mendaftarkan produk ke Badan POM. Obat yang beredar di Indonesia wajib dilakukan registrasi untuk melindungi konsumen dan menjamin mutu dan keamanan obat. Oleh sebab itu penting bagi apoteker untuk mengetahui dan menjalani praktik kerja di bidang registrasi obat.

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ABSTRACT
Internship at PT Johnson Johnson Indonesia aims to understand the role of pharmacists in the industry, one of which concerns the scope of work, duties, and the role of a regulatory officer. Regulatory officer is the person that responsibility to register the product to regulator BPOM . Drugs circulating in Indonesia must be registered to protect consumers and ensure the quality and safety of drugs. Therefore it is important for pharmacists to know and practice of working in the field of drug registration.Internship at PT Johnson Johnson Indonesia aims to understand the role of pharmacists in the industry, one of which concerns the scope of work, duties, and the role of a regulatory officer. Regulatory officer is the person that responsibility to register the product to regulator BPOM . Drugs circulating in Indonesia must be registered to protect consumers and ensure the quality and safety of drugs. Therefore it is important for pharmacists to know and practice of working in the field of drug registration.

Abstrak :
ABSTRAK
Praktik Kerja Profesi Apoteker di PT Johnson Johnson Indonesia bertujuan agar mahasiswa profesi apoteker mengetahui dan memahami tugas, peran, dan tanggung jawab apoteker di bagian regulatory affairs suatu industri farmasi. Selain itu, kegiatan Praktik Kerja Profesi juga memfasilitasi mahasiswa dalam memahami gambaran nyata permasalahan kefarmasian di industri farmasi, khususnya pada bagian regulatory affairs. Tugas khusus yang diberikan berjudul Kajian Implementasi Perkembangan Perubahan Peraturan Kriteria dan Tata Laksana Registrasi Obat terhadap Pelaksanaan Registrasi Variasi Minor Dengan Notifikasi. Tujuan dari tugas khusus ini adalah untuk mengetahui dampak dan perbedaan ketentuan peraturan perundang-undangan registrasi obat antara peraturan terbaru dengan peraturan terdahulu serta membuat dokumen registrasi untuk Registrasi Variasi Minor dengan Notifikasi.

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ABSTRACT
Internship at PT Johnson Johnson Indonesia aims to make the pharmacist 39 s professional students know and understand the duties, roles and responsibilities of the pharmacist in the regulatory affairs section of a pharmaceutical industry. In addition, internship also facilitates students to understand the real picture of pharmaceutical problems in the pharmaceutical industry, especially in the regulatory affairs section. Specific assignment given is entitled Implementation Study of Development and Change of Regulation of Criteria and Procedure of Drug rsquo s Registration to Registration of Variation Minor with Notification. The purpose of this particular assignment is to examine the impacts and differences in the provisions of drug regulatory legislation between the latest regulations with the previous regulation and to make registration documents for Minor Variation Registration with Notifications.

Abstrak :
Praktek Kerja Profesi di PT Johnson Johnson Indonesia Periode Bulan Maret - April Tahun 2018 bertujuan untuk memahami tugas dan tanggung jawab apoteker di bagian Regulatory Affairs. Selain itu calon apoteker juga dapat memiliki gambaran nyata tentang permasalahan pekerjaan kefarmasian di industri farmasi, memiliki wawasan, pengetahuan, keterampilan, dan pengalaman praktis untuk melakukan pekerjaan kefarmasian di industri farmasi. Tugas khusus yang diberikan yaitu berjudul ldquo;Analisis Implementasi Undang-Undang Jaminan Produk Halal Pada Industri Farmasi rdquo;. Tujuan dari pelaksanaan tugas khusus di PT Johnson Johnson Indonesia adalah agar industri farmasi bisa dengan matang dalam mepersiapkan diri menghadapi era halal. Setelah melakukan praktek kerja di PT Johnson Johnson Indonesia, penulis telah mendapatkan kemampuan untuk memahami peran, tugas, wawasan dan tanggung jawab apoteker dan memberikan solusi pada permasalahan di bagian Regulatory Affairs. ......Internship at PT Johnson Johnson Indonesia Period March - April 2018 aims to understand the duties and responsibilities of pharmacists at Regulatory Affairs section. In addition, the pharmacist candidate can also have the insight, knowledge, skills and practical experience to undertake pharmaceutical work in the pharmaceutical industry. The special assignment given is ldquo;Analysis of Jaminan Produk Halal Law rsquo;s Implementation for Pharmaceutical Industries rdquo;. The purpose of this special assignment is to make so that the pharmaceutical industry can make a good preparation for the halal era. After working at PT Johnson Johnson Indonesia, the author has gained the ability to understand the role, duties, insights and responsibilities of the pharmacist and provide solutions to problems in the Regulatory Affairs section.

Abstrak :
Profesi Apoteker berperan penting dalam menjaga khasiat, keamanan dan mutu obat yang beredar di masyarakat. Kegiatan Praktek Kerja Profesi yang dilaksanakan di PT Johnson & Johnson Indonesia bertujuan agar mahasiswa calon apoteker dapat mengerti peranan, tugas, dan tanggung jawab apoteker di industri farmasi tersebut. Selain itu, mahasiswa diharapkan dapat memiliki wawasan, pengetahuan, ketrampilan, dan pengalaman praktis untuk melakukan pekerjaan kefarmasian di industri farmasi terutama di bagian Regulatory Affair, memahami registrasi obat secara keseluruhan, khususnya pada registrasi variasi dan registrasi ulang, dan memiliki gambaran nyata tentang permasalahan pekerjaan kefarmasian di industri farmasi. Registrasi obat terdiri dari registrasi baru, registrasi variasi dan registrasi ulang, dimana pengajuan registrasi dilakukan dengan menyusun dossier registrasi yang diserahkan ke BPOM untuk dievaluasi. Permasalahan pekerjaan kefarmasian yang dialami Regulatory Affair adalah seringkali terdapat ketidak sesuaian dokumen yang diberikan oleh pembuat dokumen dengan persyaratan dokumen yang dibutuhkan BPOM. Tugas khusus yang diberikan saat Praktek Kerja Profesi di Industri Farmasi adalah Kajian Kelengkapan Dossier Registrasi Obat dari Global Regulatory Affair Johnson & Johnson terhadap Ketentuan Kelengkapan Dokumen Registrasi Obat di Indonesia. Tugas khusus ini memiliki tujuan agar mahasiswa dapat menghitung persentase ketidaklengkapan dossier registrasi yang diberikan Global RA kepada Lokal RA, serta melakukan analisis penyebab ketidaklengkapan dossier tersebut. ...... Pharmacists profession plays an important role in maintaining efficacy, safety and quality of medicines that circulating in community. Professional Internship Programs that held in PT Johnson & Johnson Indonesia aims that pharmacists can understand the role, duties and responsibilities of pharmacists in pharmaceutical industry. In addition, students are expected to have the insight, knowledge, skills and practical experience to do the work of pharmacy in pharmaceutical industry, especially in Regulatory Affair, understanding drug registration, particularly on the registration variations and re-registration, and have a real picture of the work pharmacy problems in the pharmaceutical industry. Drug registration consists of a new registration, registration variations and re-registration, which submitted for registration by drafting a registration dossier to BPOM to be evaluated. Problems in Regulatory Affair is theres often a discrepancy documents provided by author of the document with BPOMs required paperwork. Special assignment given at the Professional Internship Programs is the Study of Drug Registration Dossier completeness of Global Regulatory Affair Johnson & Johnson against Drug Registration Document Completion Conditions in Indonesia. The purpose of this special assignment to allow students calculate incompleteness percentage of registration dossier given from Global RA to Local RA, and analyze the cause of dossier incompletenes.

Abstrak :
Praktik kerja profesi di Johnson & Johnson Indonesia Periode Agustus – September Tahun 2018 bertujuan untuk mengetahui tugas dan tanggung jawab apoteker di industri farmasi dan memahami penerapan Cara Pembuatan Obat yang Baik (CPOB) di Industi Farmasi. Selain itu, calon apoteker juga dapat memiliki gambaran nyata tentang permasalahan pekerjaan kefarmasian di industri farmasi, memiliki wawasan, pengetahuan, keterampilan, dan pengalaman praktis untuk melakukan pekerjaan kefarmasian di industri farmasi khususnya sebagai regulatory affairs . Tugas khusus yang diberikan yaitu berjudul “Updating terhadap Manajemen Registrasi Variasi Berdasarkan PerKaBPOM No.24 Tahun 2017 melalui Sistem RIACS di PT. Johnson & Johnson Indonesia”. Tujuan dari pelaksanaan tugas khusus di Johnson & Johnson Indonesia adalah untuk mengenal sistem RIACS di PT. Johnson & Johnson Indonesia dan memperbaharui sistem database RIACS berdasarkan PerKaBPOM No.24 Tahun 2017. ......Internship at Johnson & Johnson Indonesia Period August – September 2018 aims to determine the duties and responsibilities of pharmacists in the pharmaceutical industry and understand the application of Good Drug Manufacturing Practices (CPOB) in the Pharmaceutical Industry. In addition, prospective pharmacists can also have a real picture of the problems of pharmaceutical work in the pharmaceutical industry, have insight, knowledge, skills, and practical experience to do pharmaceutical work in the pharmaceutical industry especially as regulatory affairs. The specific task given is entitled "Updating the Management of Variation Registration Based on PerKaBPOM No.24 of 2017 through the RIACS System at PT. Johnson & Johnson Indonesia ". The purpose of implementing a special task at Johnson & Johnson Indonesia is to get to know the RIACS system at PT. Johnson & Johnson Indonesia and renewing the RIACS database system based on PerKaBPOM No.24 of 2017.