Background

Real-World Data (RWD) are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. Real-World Evidence (RWE) is the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD. RWD can be analyzed to produce RWE on the usage and/or benefits and risks of a medication or a medical product. RWD and RWE offer the possibility to bring about novel insights on patients’ clinical care, regulatory decision-making, and health technology assessment. Detailed information on data sources, data standards, data reliability, how to generate evidence, and regulatory considerations can be found on FDA’s document titled Framework for FDA’s Real-World Evidence Program (U.S. FDA, 2018). RWE has the potential to supplement information derived from clinical trials, providing accessible data in a shorter time and at lower costs. This is especially relevant to pediatrics, where the evidence base to guide medication use in children may be insufficient. Studies using RWD offer the opportunity to assess long-term effects and the safety of medications that are used to treat pediatrics population (Lasky et al., 2020). read more

Background

Real-World Data (RWD) are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. Real-World Evidence (RWE) is the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD. RWD can be analyzed to produce RWE on the usage and/or benefits and risks of a medication or a medical product. RWD and RWE offer the possibility to bring about novel insights on patients’ clinical care, regulatory decision-making, and health technology assessment. Detailed information on data sources, data standards, data reliability, how to generate evidence, and regulatory considerations can be found on FDA’s document titled Framework for FDA’s Real-World Evidence Program (U.S. FDA, 2018). Randomized Controlled Trials have limited external validity since the results from a study conducted in a specially selected homogeneous patient subpopulation, and carried out under ideal circumstances, may not necessarily extend well to the general (heterogeneous) patient population with complex care needs, multiple comorbidities, or concomitant medications (Katkade et al, 2018). read more

Background

Data related to patient health status and/or the delivery of health care routinely collected from a variety of sources have been defined as Real-World Data (RWD) by the FDA. On the other hand, Real-World Evidence (RWE) is described as clinical evidence about the usage and potential benefits or risks of a medical product derived from an analysis of RWD. RWD and RWE offer the possibility to bring about novel insights on patients’ clinical care, regulatory decision-making, and health technology assessment. Detailed information on data sources, data standards, data reliability, how to generate evidence, and regulatory considerations can be found on FDA’s document titled Framework for FDA’s Real-World Evidence Program (U.S. FDA, 2018). In oncology, RWE refers to evidence derived from the use and analysis of real-world data, which are data obtained outside the context of conventional randomized controlled trials (Khozin et al., 2017). read more

Departemen Farmakologi dan Terapi FK-KMK UGM menyelenggarakan workshop dan webinar 4th Jogjakarta Annual Meeting of Pharmacology en Therapy (JAPEMETHE)  dengan Tema ” Obat Modern Asli Indonesia (OMAI): From Bench to Bedside ”

1. Workshop  diselenggarakan pada:

Program Studi Magister Ilmu Biomedik (MIB), Fakultas Kedokteran, Kesehatan Masyarakat, dan Keperawatan UGM (FK-KMK UGM) kembali mengadakan kegiatan webinar series dengan judul Kegiatan Perbincangan dan seminar berbasis biomedis atau disingkat dengan (PSBB). Kegiatan ini merupakan wadah untuk berbagi ilmu dan pengetahuan dalam lingkup keimuan kedokteran dasar sekaligus menjadi sarana promosi dan diseminasi informasi mengenai minat-minat program pasca sarjana ilmu biomedik yang berada lingkungan FK-KMK UGM read more

Departemen Farmakologi dan Terapi, FK-KMK UGM kembali membersembahkan seminar daring ke-3 dari serial seminar dengan tema “The Importance of Big Data in Improving the Quality of Healthcare”. Seminar kali ini membahas tentang “Therapeutic Risk Management (Manajemen Risiko Terapetik)”.

Seminar ini bertujuan untuk meningkatkan kesadaran akan pentingnya manajemen risiko terapeutik dalam peningkatan kualitas pelayanan kesehatan, baik pelayanan kesehatan rutin, perumusan kebijakan, dan penelitian. Selain itu, diskusi akan berlanjut dengan usaha mendefinisikan masalah kualitas pelayanan kesehatan dan evaluasi obat, pemahaman tentan manajemen risiko alat kesehatan, serrta rencana kerja pengendalian risiki di bidang kesehatan read more

Departemen Farmakologi dan Terapi, FK-KMK UGM menyelenggarakan Rapat Kerja Departemen 2021-2025 pada hari Jumat, 29 Januari 2021, secara daring. Pertemuan ini dihadiri oleh seluruh keluarga besar Departemen Farmakologi dan Terapi, yang meliputi dosen aktif, dosen luar biasa dan tenaga kependidikan di lingkungan departemen. Agenda penting pertemuan ini adalah pembahasan laporan kegiatan 2016-2020 dan target kerja departemen dalam 5 tahun ke depan (2021-2025). Acara dibuka oleh Kepala Departemen Farmakologi dan Terapi, Dr. dr. Eti Nurwening Sholikhah, M.Kes., M.Med.Ed. yang berlanjut dengan penyampaian laporan kegiatan departemen periode 2016-2020, perumusan visi misi, dan pembaharuan struktur organisasi. Koordinator masing-masing divisi kemudian memaparkan hasil kerja dan target divisi dalam beberapa tahun ke depan terutama dalam penyelenggaraan Tri Dharma Perguruan Tinggi. Dalam pertemuan tersebut, segenap civitas akademika Departemen Farmakologi dan Terapi bersepakat untuk terus meningkatkan kinerja departemen dalam bidang Tri Dharma, termasuk peningkatan SDM, peningkatan penelitian-publikasi-pengabdian masyarakat, dan modifikasi pembelajaran daring di masa Pandemi. read more

Terkait dengan pemberitaan penarikan obat antihipertensi yang mengandung zat aktif Valsartan, berikut klarifikasi dari BPOM:

“Sehubungan dengan penarikan obat antihipertensi yang mengandung zat aktif valsartan di Uni Eropa dan berdasarkan informasi dari lembaga pengawas obat dan makanan di beberapa negara, BPOM RI memandang perlu memberikan penjelasan sebagai berikut: