Patient safety in clinical trials and the safety of patients taking drugs and biologics already in the US market have become increasingly important, not only to patients, their health care providers, and FDA, but increasingly to the general public and US Congress as news reports relay drug safety problems. FDA regulations and guidance, corresponding requirements in other countries, as well as guidance by the International Conference on Harmonisation (ICH) are continually changing and can be confusing or even, contradictory. In addition, patient advocacy groups, the US Congress, and those unfamiliar with the complexity of drug development are exerting more and more pressure on FDA and sponsors to shorten drug development timeframes yet guarantee no serious adverse drug effects—an impossibility. So what should a sponsor do?
In this two day workshop, participants will learn best practices for meeting FDA and broader real world safety requirements as time and cost efficiently as possible, and how to devise robust systems for collecting and reporting these data. In-class exercises will help attendees write better short safety reports of various types and become aware of the most common problems FDA spots so as to avoid them.
Through case studies, the course will examine best practices to develop for the first time, or to improve, your company’s clinical safety reporting to FDA. Additionally, case studies will demonstrate how your signal monitoring and analysis practices can help or hurt your relationship with FDA, health-care providers, and the general public.
- Understand what safety information FDA wants and when
- Know best practices for setting up reliable safety reporting systems internationally, when the US/FDA is just one part
- Be able to prepare concise and accurate safety reporting documents required at any stage of drug development in the US
- Understand what FDA is looking for in safety reporting and what are red flags for FDA that you want to avoid
Who will Benefit:
This course is designed for those responsible for developing, maintaining and/or overseeing clinical safety/pharmacovigilance duties or filing clinical trial or marketing application submissions to FDA. The following personnel will benefit from the course:
- Human Safety/Pharmacovigilance Staff
- Submissions Medical Writers and Editors
- Clinical Operations
- Regulatory Affairs
- Regulatory Operations
- Project Managers
- Data Management
- US Agents
- Compliance Professionals
- Process Owners
- Document Control Specialists