Found in:
Clinical Safety & Pharmacovigilance
Advanced digital tools foster a more practical approach to obtaining complete adverse event information versus iterative communication
Found in:
Regulatory, Clinical Safety & Pharmacovigilance
Information Pertaining to Additional Safety Protections Regarding Use of Fecal Microbiota for Transplantation: Screening Donors for COVID-19 and Exposure to SARS-CoV-2 and Testing for SARS-CoV-2
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Article, Clinical Development & Operations, Quality Assurance, Quality Control, Clinical Safety & Pharmacovigilance, Clinical Supplies, Data & Data Standards, Medical Affairs, Medical Writing, PE / Quality of life / Health, Preclinical & Early Phase Research, Project Management & Strategic Planning, Regulatory, Rare Disease & Special Populations, Statistics, Value & Access
When you hear about investing, you may think about savings and stock accounts. But when it comes to investing in your career, the focus may shift to education, including degrees, didactic courses, certifications, and trainings.
Found in:
Clinical Safety & Pharmacovigilance
The Canadian opioid crisis is being treated as a public health emergency, and, given its breadth and urgency, a broad range of creative actions are being pursued in the areas of prevention, treatment, harm reduction, and enforcement.
By Jonathan P. Jarow, MD; Steven Lemery, MD, MHS; Kevin Bugin, MS, RAC; Naomi Lowy, MD
Found in:
Article, Regulatory, Clinical Safety & Pharmacovigilance
The purpose of this study was to describe the role of the US Food and Drug Administration (FDA) in ensuring the safety of...
By Bert P. van Leeuwen, MD; Christine Prendergast, MSc; Brian Edwards, MD, MRCP; Barbara Dawson, BSc(Hons)
Found in:
Article, Clinical Safety & Pharmacovigilance, Outsourcing
Outsourcing in pharmacovigilance has grown in the past decade. However, standards are lacking in this area, both for...
By Marina Lengsavath, MSc; Anne Dal Pra, PharmD; Anne-Marie de Ferran, PharmD; Sabine Brosch, MPharm, RN; Dr. Linda Härmark, PharmD, PhD; Victoria Newbould, MSc; Susana Goncalves, PharmD
Found in:
Article, Regulatory, Clinical Safety & Pharmacovigilance
In the context of the European Union’s Innovative Medicines Initiative (IMI) project titled Web-Recognizing Adverse Drug...
By Dr. Tatsuo Kurokawa, DIA President
Found in:
Article, Clinical Safety & Pharmacovigilance
When I was a young boy in pharmacy school, I thought that a pharmaceutical company involved nothing more than the R&D of new...
By Yasuo Sugitani, MSc; Yukio Udagawa, BS; Shinichi Matsuda, MSc; Kana Yamada, MSc; Natsuko Miyawaki, MSc; Ichiro Konishi, MD, PhD, MBA
Found in:
Article, Clinical Safety & Pharmacovigilance
While benefit-risk (B-R) assessment in the real-world setting is an important challenge for pharmacovigilance, few studies...