This webinar will provide participants with an understanding of the regulatory reporting requirements when Adverse Drug Reaction (i.e. Adverse Events) occurs at the investigational stage of a Clinical Trial.
Adverse event identification and reporting requirements will be reviewed, as well as FDA training and ICH roles in the drug safety process. The webinar will also discuss ICH training guidelines and current regulatory issues regarding adverse event reporting requirements specific to the United States.
Why Should You Attend
Understand what Adverse Events, Serious Adverse Events and Unanticipated Problems are, and why reporting them is important to a study hypothesis and is key to keeping subjects safe while on a clinical trial
Learn the responsibilities of the Sponsor, Site/Clinical Investigator and Regulatory Agency in the reporting of Adverse Events
Become familiar with current issues regarding Adverse Event reporting specific to the United States
Have an understanding of what role the FDA and ICH Guidelines play in determining the safety of a drug
Areas Covered in this Webinar
Adverse Event (AE) and Serious Adverse Event Terminology: Definitions
Roles & Responsibilities of the Sponsor and the Regulatory Agency in AE reporting
Exclusions from SAE Reporting
Investigator Notification Letters/ IND Safety Reports
Case Studies and Scenarios
Identify when a Serious Adverse Event does not require reporting
Understand what the site obligations are in both assessing causality of adverse events as well as reporting these events to the sponsor
Learn the circumstances under which Investigator Notification Letters are released as well as responsibilities for notification of clinical sites as well as the FDA
Who Will Benefit
Clinical Research Professionals
Safety Surveillance Personnel
Regulatory Affairs Personnel
Medical Affairs Personnel
Nicole began her career in Clinical Research over 17 years ago as a Clinical Research Associate for a small Clinical Research Organization. The “accidental” career that began after receiving her undergraduate degree has proven to be rewarding, challenging and continues to inspire her to do more and learn more in the field of Clinical Research.
Nicole has held roles such as CRA, Lead CRA, Project Manager, Regional Operations Manager, and Auditor.
In 2013 she started Harmony Clinical Consulting, providing consulting services to the pharmaceutical and biotech industries.
Nicole has experienced working for “Big Pharma” as well as small Biotech companies. Her focus is in Oncology, rare disease and orphan drugs has provided her with the opportunity of being a contributor in the development of Myleran® (Busulfan) for Pediatric BMT, Herceptin® (Trastuzumab) for Metastatic Breast Cancer, TYKERB® (Lapatinib) for Breast Cancer and MYALEPT® (metreleptin) for Lipodystrophy.
Nicole is currently working as an independent consultant for Acerta Pharma BV in collaboration with The Ohio State University on a second generation BTK inhibitor to treat Chronic Lymphocytic Leukemia.