The Regulatory Writing course at Landmark Research provides specialized training in creating essential documents for regulatory submissions.

This course covers the preparation of clinical evaluations, clinical investigations, and comprehensive regulatory documents in line with global standards.

The training emphasizes the importance of adhering to regulatory requirements, ensuring document accuracy, and maintaining ethical standards in clinical regulatory writing.

ISO 14155: Clinical investigation of medical devices for human subjects

This ISO 14155 course provides a comprehensive overview of clinical research standards and ethical considerations, highlighting the scope, planning, conduct, and closeout of clinical investigations. It delves into the responsibilities of sponsors and principal investigators, emphasizing adherence to Good Clinical Practice (GCP) principles, ensuring participant safety, and maintaining regulatory compliance throughout the study lifecycle.

Clinical Evaluation Guideline and Regulation for Medical Devices in the EU Region

This course provides an in-depth overview of how medical devices reach the market, focusing on regulatory bodies, conformity assessments, and key terminologies. It covers the clinical evaluation process under EU MDR 2017/745, detailing the stages of clinical evaluation, the role of clinical evaluators, and key principles. Additionally, it discusses guidelines and EU regulations pertinent to clinical evaluations and medical device classifications.

Clinical Investigation for Medical Devices and ISO 14155

This course provides a detailed introduction to clinical research for medical devices, covering Good Clinical Practice (GCP) and ISO 14155 guidelines. It outlines the development, regulatory requirements, and risk management of medical devices, as well as the planning, start-up, conduct, and termination of clinical studies. It details the responsibilities of sponsors and investigators and addresses the financial aspects of managing clinical investigations.