webinar – intro to adverse event review
Wednesday, July 18, 2018 | 11:00 AM PST / 1:00 PM EST
Duration: 60 Minutes
This webinar will introduce why safety reviews are essential in the entire life cycle of product development.
- Describe the history of how the concept of safety reviews evolved since its first conception
- Describe the FDA guidelines pertaining to safety monitoring
- Describe the components of AE review as it pertains to screening for reportability and adjudicability
- Describe how individual AE reviews impact the “big picture” in meeting regulatory requirements for safety reporting beyond product approval
- Parties (CEC, DSMB, dose-escalation committee, product performance, medical affairs, etc.) in ensuring patient safety
- Signal detection, trending, AOSE (analysis of similar events)
Laurie Mitchell | Founder/President of Criterion Edge, a global regulatory writing services firm serving the medical device, pharmaceutical, and biotech industries. She has over 25 years experience in medical writing, pharmacovigilance management, and regulatory reporting. Prior to Criterion Edge, Laurie founded Mitchell Research Group, a successful site management organization, and acted as a Clinical Safety consultant for Abbott Vascular for almost a decade. Laurie brings extensive experience creating and training Data Safety Monitoring Boards and Clinical Event Committees and working with global cross-functional teams. Having worked for three of the four major medical device sponsors, she maintains expertise in many therapeutic areas. She holds a BS in Nursing and an MS as a Cardiopulmonary Clinical Nurse Specialist from UCLA.
Who should attend?
Senior professionals working with adverse events reporting:
- Clinical Scientist
- Clinical Safety Specialist
- Clinical Trial Project Managers
- Clinical Data Managers
- Clinical Research Associates (CRAs)
- Medical Monitors
- Drug Safety Specialist
- Pharmacovigilance Professionals