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All Journal JISIP: Jurnal Ilmu Sosial dan Pendidikan Pharmaceutical Journal
Putri, Tiara Ananda
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Arts Humanities Dentistry Education Law, Crime, Criminology & Criminal Justice Medicine & Pharmacology Nursing Public Health Social Sciences Other

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Dampak Harmonisasi Regulasi Farmasi terhadap Akses Obat dan Keamanan Pasien Aminudin; Azzahra, Naila; Putri, Tiara Ananda; Aprianto, Yakobus
Pharmaceutical Journal Vol. 1 No. 2 (2025): August Editions
Publisher : Program Studi Farmasi Sekolah Tinggi Ilmu Kesehatan Sambas

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Abstract

This study is a literature review that aims to comprehensively examine health and drug regulation from three perspectives: the implementation of Real-World Evidence (RWE), the application of Good Regulatory Practices for Medicines (CROB), and a comparison of health regulations across countries. Using a literature review method, the findings indicate that Indonesia faces significant challenges in integrating RWE into its drug approval system, particularly due to limited data infrastructure, regulatory gaps, and data ethics issues. On the other hand, the CROB guidelines issued by the National Agency of Drug and Food Control (BPOM) represent a crucial effort to build a regulatory system that is transparent, accountable, and evidence-based. Furthermore, cross-country comparisons affirm that strict regulations positively impact the quality of healthcare services, enhancing patient safety and the competence of medical personnel. This study concludes that adaptive, integrated, and consistent regulation is essential to ensure the quality of medicines and healthcare services, and that harmonizing policies across sectors and countries is necessary to address global health challenges.
WORKSHOP TARI JAIPONGAN DI KBRI WINA DITINJAU DARI PRESPEKTIF DIPLOMASI KEBUDAYAAN Putri, Tiara Ananda
JISIP: Jurnal Ilmu Sosial dan Pendidikan Vol 6, No 2 (2022): JISIP (Jurnal Ilmu Sosial dan Pendidikan)
Publisher : Lembaga Penelitian dan Pendidikan (LPP) Mandala

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.58258/jisip.v6i2.3152

Abstract

Penelitian ini bertujuan untuk mengkaji norma hukum tertulis mengenai Ekspresi Budaya Tradisional dalam Undang-Undang Hak Cipta, dan Undang-Undang Pemajuan Kebudayaan. Penelitian ini secara khusus dilakukan untuk menganalisa kegiatan Workshop Tari Tradisional Jaipongan yang dilakukan di KBRI Wina mengunakan prespektif Undang-Undang Hak Cipta, dan Undang-Undang Pemajuan Kebudayaan. Penelitian ini akan dianalisis secara kualitatif. Data yang dihasilkan adalah data deskriptif analitis. Melalui kegiatan Workshop Tari Jaipongan yang dilaksanakan oleh KBRI Wina, Pemerintah telah melaksanakan tugasnya dalam Pemajuan Kebudayaan yang tertera di UU Pemajuan Kebudayaan dan sebenarnya setiap orang dapat melakukan Pemanfaatan Objek Kebudayaan
Co-Authors AMINUDIN Aprianto, Yakobus Azzahra, Naila