Biosimilar epoetin for cancer and chemotherapy-induced anaemia in the US

Biosimilars are biological drug products that are highly similar to reference products in analytic features, pharmacokinetics and pharmacodynamics, immunogenicity, safety and efficacy. Biosimilar epoetin received US Food and Drug Administration (FDA) approval in 2018 [1]. The manufacturer received an FDA non-approval letter in 2017, despite receiving a favourable review by the FDA’s Oncologic Drugs Advisory Committee (ODAC) and an FDA non-approval letter in 2015 for an earlier formulation.

Limitation of Harbormaster Responsibility in Ship Accidents

As the government in the port, the harbormaster has the responsibility to guarantee the safety and security of shipping. In shipping, the harbormaster, shipowner and captain are the trident of the security and safety of shipping. This research is a normative-legal research using a statute, comparative and conceptual approaches. The research results indicate that the concept of limiting the responsibility of a harbormaster in a ship accident is a ship accident not necessarily a criminal offense prior to the preliminary examination by the harbormaster and a further examination by the shipping court, if the results of the examination indicate a criminal act, the parties The police can conduct investigations into ship accident events based on the results of the examination by the harbormaster and the shipping court. In the event of a ship accident, the harbormaster has a relative or limited responsibility to the fulfillment and compliance of the implementation of maritime safety, security and safety of shipping in the form of the issuance of a sailing approval letter for ships leaving the port in accordance with applicable rules and procedures so that the harbormaster is not absolutely responsible for the circumstances that occur after the ship leaves port, but it has become the authority and responsibility of the ship commander. Received: 17 January 2021 / Accepted: 9 April 2021 / Published: 10 May 2021

TINJAUAN PROSEDUR PENANGANAN SURAT KELUAR PADA DIVISI HUMAN CAPITAL DI KIMIA FARMA (PERSERO) TBK

ABSTRAK Aktivitas penanganan surat di setiap instansi atau perusahaan menjadi salah satu kegiatan yang mendukung kegiatan utama di instansi atau perusahaan. Salah satu penanganan surat adalah surat keluar. Penangangan surat keluar harus dilaukan dengan baik karena berhubungan dengan pihak eksternal atau instansi lain. Prosedur penanganan surat yang baik merupakan salah satu peranan penting bagi kegiatan surat menyurat. Penanganan surat ini bertujuan agar surat terdokumentasi dengan rapih sehingga dapat ditemukan kembali dengan cepat dan mudah. Adapun manfaat penanganan surat apabila ditangani dengan baik yaitu surat-surat yang ditangani akan tercatat dengan baik, prosedur penanganan surat jelas, surat akan tersimpan baik sehingga mudah untuk ditemukan, rahasia isi surat akan terjaga. Penelitian dilakukan dengan menggunakan metode kualtitif dengan analisis secara deskriptif. Data primer yang diolah merupakan hasil obeservasi, interview atau wawancara dengan narasaumber pada bagian Unit Talent Acquisition divisi Human Capital. Prosedur penanganan surat keluar yang dilakukan oleh PT Kimia Farma (Persero) Tbk adalah penyiapan konsep surat, pengetikan dan penyuntingan surat, persetujuan surat, pengiriman surat. Hasil penelitian menyatakan bahwa prosedur penanganan surat keluar belum diterapkan sesuai dengan kebijakan perusahaan dimana prosedur yang diterapkan dianggap lebih ringkas dan lebih efektif. Prosedur penanganan surat keluar yang di perusahaan meliputi penyiapan konsep, pengetikan dan penyuntingan surat, persetujuan surat dan pengiriman surat. Kata-kata Kunci: Prosedur, Penanganan surat, Surat Keluar, Konsep Surat. ABSTRACT The activity of handling letters in each agency or company is one of the activities that support the main activities of the agency or company. One of the handling of mail is outgoing mail. Outgoing mail handling must be done properly because it relates to external parties or other agencies. Good mail handling procedures are an important role for correspondence activities. The purpose of handling this letter is so that the letter is neatly documented so that it can be recovered quickly and easily. As for the benefits of handling letters if handled properly, namely the letters handled will be recorded properly, the procedures for handling letters are clear, the letters will be stored properly so that they are easy to find, the secret of the contents of the letters will be protected The research was conducted using a qualitative method with descriptive analysis. Primary data that is processed is the result of observations, interviews or interviews with sources in the Talent Acquisition Unit of the Human Capital division. The procedures for handling outgoing letters carried out by PT Kimia Farma (Persero) Tbk are preparation of letter drafts, typing and editing letters, letter approval, letter delivery. The results of the study stated that the procedure for handling outgoing mail had not been implemented in accordance with company policy where the procedures applied were considered more concise and more effective The procedure for handling outgoing mail in the company includes drafting, typing and editing letters, letter approval and letter delivery. Keywords: Procedures, Mail Handling, Outgoing Mail, Draft Letter

A Legal Review of Sailing Approval Letter: Systems and Procedures

Every ship that is going to sail is required to have a sailing approval letter issued by the harbormaster as an effort to control the security and safety of shipping. This research is a normative-legal research using a statute, comparative and conceptual approaches.The results show that the harbormaster as a government official at the port carries out and supervises efforts to fulfill shipping safety and security as a government administrative action by issuing a state document in the form of a sailing approval letter through a system of procedures for issuing a sailing approval letter. This letter is given to every ship that will sail or leave the port by ensuring that the ship, crew and cargo have technically-administratively fulfilled all sailworthiness requirements. The compliance of all parties in implementing the procedure for the issuance of the sailing approval will lead to the achievement of safety and security in shipping.

CRIMINAL LIABILITY OF FISHERY PERPETRATOR ACCORDING TO FISHERY LAW NUMBER 45 OF 2009 CONCERNING AMENDMENT TO LAW NUMBER 31 OF 2004

Many occurrences of fisheries criminal offenses make the writer interested to learn about criminal provisions and the responsibility of the perpetrators according to Law No. 45 of 2009 concerning amendments to Law No. 31 of 2004 concerning Fishery. By studying, understanding, and analyzing these articles of law, the author significantly obtains the picture of whether this Fishery Law is appropriate and able to force the perpetrator of their responsibility for their actions. The purposes of this paper are 1) To analyze the patterns of fishery criminal so the perpetrators could be charged their responsibilities according to Law No. 45 of 2009, 2) To study and analyze how to determine the penalties according to the Law No. 45 of 2009. This paper is a qualitative descriptive. The method of this research is normative law with conceptual and institutional approaches. The result of the study showed that legislation in Indonesia relating to Fisheries, administratively, there are still several articles that are sticking out and controversy according to Law No. 45 of 2009 concerning amendments to Law No. 31 of 2004 concerning Fishery. For small fishermen who do not have a Yachting Approval Letter (SPB) in Indonesia should be subjected to administrative sanctions such as paying compensation. If administrative sanctions are not implemented, then the principle of ultimum remedium can be applied as a last choice in violations of fisheries and there are still several articles that are detrimental to the interests of the State as well as the interests of local fishermen which, if seen from criminal liability, may be imposed.

PENERBITAN SURAT PERSETUJUAN BERLAYAR KAPAL PERIKANAN PADA KANTOR UNIT PENYELENGGARA PELABUHAN BANGGAI

In the context of shipping protection and safety, it is necessary to obtain approval of the Sailing Agreement by Syahbandar. This paper is to find out the procedures approved by the Fishing Boat Approval Letter at the Banggai Port Operator Unit Office, and to find out and analyze the factors that influence it. The research used is empirical juridical with primary, secondary and tertiary data collection. Procedures for approving Fishing Vessel Approval Letters at the Banggai Port Operational Unit Office, approving applications for approval of Sailing (SPB), checking the administration and physical condition of vessels, and issuing Sailing Approval Letters (SPB). As a factor influencing the Fishing Boat Sail Approval Letter in the Banggai Port Operator Unit Office, it consists of supporting factors, namely legal factors and supporting factors. While the inhibiting actors are the Number of Human Resources and the inaccuracy of applicants.

Crime of Illegal Fishing in Indonesian Exclusive Economic Zone in the Perspective of Economic Crime

The losses arising from illegal fishing in Indonesian EEZ are IDR 101,040,000,000. Economic losses related to fisheries resources are a form of violation in the economic field so that it can be included in terms of crime in the economic field. The problems raised in this study include what are the legal consequences of the crime of illegal fishing in Indonesia’s exclusive economic zone and how it is viewed from an economic crime perspective. This study applies a normative juridical method by reviewing the relevant legal materials of legislation and theories to the results of the research as the following: 1) fishing in the area of the Exclusive Economic Zone, based on jurisdictional theory, can be regulated by the Indonesian state as a sovereign coastal country where the regulation is strictly in accordance with Article 5 of the Indonesian Exclusive Economic Zone Law; moreover, if the obligation to have a Fishing Approval Letter (SIPI) and a Fish-Carrier Ship Approval Letter (SIKPI) is violated, violators will be subject to punishment in accordance with Articles 93, 94 and 94A of Law No. 45 of 2009, 2) losses incurred as a result of the crime of illegal fishing in the Exclusive Economic Zone can be detrimental to the country’s economy in the field of fisheries resources; so, according to the theory of economic approaches and broad economic crime definitions, the crime of illegal fishing in EEZ Indonesia is part of economic crime.

Kajian Penyederhanaan Penerbitan "Surat Persetujuan Kegiatan Pekerjaan Salvage Dan Surat Persetujuan Kegiatan Pekerjaan Bawah Air"

The rapid advancement of science, information and communication technology as well as changes in the strategic environment demands for reform of government bureaucracy and tailored to the demands of the community dynamics. Therefore it should be taken the steps that are fundamental, comprehensive and systemic so that goals and targets that can be achieved effectively and efficiently. Assessment Approval for Issuance of Salvage Job Activity and Job Approval Underwater Activities that took place in Jakarta is intended to provide licensing services that are transparent, accountable, faster and ensure legal certainty and certainty for actors in the field of transportation. Sampling was conducted on 17 companies salvage and underwater works in Jakarta and surrounding areas. Analysis of simplification and analysis of public satisfaction index (IKM) is used to measure people's satisfaction. From the results of the study appear in the overall value of the index is 3.02 expressed satisfaction both categories because they are on the range of values from 2.51 to 3.25. Highest satisfaction scores are at the service of security elements (3.5) is very good and the lowest satisfaction scores are at the speed of service element (2.7) and certainty of service charges (2.7), this value is still in good assessment scores for respondents. Simplification of the analysis, the publication "approval letter salvage work activities and work activities subpoena under water" still can be simplified, include: processing time, the implementation of one-stop service, and application of ICT. Keywords: Salvage, regulation, public satisfaction index Pesatnya kemajuan ilmu pengetahuan, teknologi informasi dan komunikasi serta perubahan lingkungan strategis menuntut birokrasi pemerintahan untuk direformasi dan disesuaikan dengan dinamika tuntutan masyarakat. Oleh karena itu harus segera diambil langkah-langkah yang bersifat mendasar, komprehensif, dan sistemik sehingga tujuan dan sasaran yang telah ditetapkan dapat dicapai dengan efektif dan efisien. Kajian Penerbitan Surat Persetujuan Kegiatan Pekerjaan Salvage dan Surat Persetujuan Kegiatan Pekerjaan Bawah Air yang mengambil lokasi di Jakarta dimaksudkan untuk dapat memberikan pelayanan perizinan yang transparan, akuntabel, cepat dan menjamin kepastian hukum serta kepastian berusaha bagi pelaku di bidang transportasi. Pengambilan sampel dilakukan terhadap 17 perusahaan salvage dan pekerjaan bawah air di DKI Jakarta dan sekitamya. Analisis simplikasi dan analisis indek kepuasan masyarakat (IKM) digunakan untuk mengukur kepuasan masyarakat. Dari hasil penelitian terlihat secara keseluruhan nilai indek kepuasan masyarakat adalah 3,02 menyatakan kategori baik karena berada pada rentang nilai 2,51-3,25. Nilai kepuasan tertinggi berada pada unsur keamanan pelayanan (3,5) sangat baik dan nilai kepuasan terendah berada pada unsur kecepatan pelayanan (2,7) dan kepastian biaya pelayanan (2,7), nilai ini masih dalam skor penilaian baik bagi reponden. Dari hasil analisis simplikasi, penerbitan "surat persetujuan kegiatan pekerjaan salvage dan surat persetujuan kegiatan pekerjaan bawah air" masih dapat disederhanakan, meliputi; waktu pengurusan, penerapan pelayanan satu atap, dan penerapan TIK.Kata kunci: Salvage, regulasi, indek kepuasan masayrakat (IKM)

ANALISIS PROSEDUR PENERBITAN SURAT PERSETUJUAN PENGELUARAN BARANG (SPPB) PADA KANTOR PENGAWASAN DAN PELAYANAN BEA DAN CUKAI TIPE MADYA PABEAN C MANADO

The one way to be able to control and supervise issuance of Approval Letter of Expenditure of Goods (SPPB) of import by carrying out the procedures and rules that apply. In the regulation of the Director General of Customs and Excise No. PER-16/BC/2016 concerning Hints Implementation Spending Goods Import For Used, explain about system work service Notice Import Goods (PIB) to on publishing Letter Approval Spending Goods (SPPB). Aim research this is for knowing procedure publishing Letter Objection Spending Goods (SPPB) on Oversight Office and Customs and Excise Type Madya Customs C Manado already corresponding or not yet corresponding with regulations director General of Customs and Excise No. PER-16 / BC / 2016. Research this use method research qualitatively. Results from research this that is procedure publishing Letter Approval Spending Goods (SPPB) already corresponding with rules director Jen deral Customs and Excise Number: PER -1 6 / BC / 2016. D iharapkan K antor Supervision and Customs and Excise Type Madya Customs C Manado continue improve quality in publishing Letter Approval Spending Goods (SPPB) imports, because now this so many goods imports coming in dae rah customs and need accuracy in p examination from stage importer fill and make Notice Import (PIB) to publishing Letter Approval Spending Goods (SPPB) so as not happen import prohibited goods sign in to in area customs and no reduce State revenue.Keywords : Procedures, rules, SPPB, import.

Human research review committee requirements in medical journals

Purpose: Independent ethical review committees safeguard participants in human research. The purpose of this study was to describe the current ethical guidelines for human research requirements in the Instructions to Authors of the English language medical journals previously studied in 1995. Methods: The instructions to authors of English language medicine journals from the Abridged Index Medicus were searched for any policies regarding guidance on the ethical treatment of human subjects in research. Results: More medical journals require independent ethics committee approval of human research now [84/101 (83%)] than 10 years ago [48/102 (47%) (P < 0.001)], and most journals continue to require that this disclosure appear in the manuscript [71/84 (85%) vs. then 37/48 (77%) (P=0.29)]. Fewer medical journal instructions to authors provide no ethical guidelines for human research now [8/101 (8%)] than 10 years ago [25/102 (24%) (P < 0.001)]. No journal required submission of the study approval letter or of the approved protocol. Conclusions: Although medicine journals increasingly require disclosure statements of independent ethics committee approval for human research, they fail to verify such approval beyond taking authors for their word.