This Webinar will introduce the drug safety landscape, regulatory changes that have increased reporting requirements, and how the application of data standards and reporting standards work together to enhance the quality of safety data.
- Appreciate the drug safety landscape
- Understand the basics of pharmacovigilance
- Understand the basics of drug safety
- Appreciate the application of data standards and reporting standards in drug safety and pharmacovigilance
Who Should Attend:
Data management professionals, who may be receiving
a broad overview of drug safety and pharmacovigilance.
Meet the Instructor
Ling Chin, MD, MPH
President & Medical Director
GDU Clinical Trials Consulting, LLC
Ling Chin has 22 years of experience in clinical trials drug development as FDA medical reviewer, medical monitor, NIH clinical trials research program director, DSMB executive administrator, head of safety and pharmacovigilance. Throughout her career, Ling directed and implemented the strategic revision of safety & pharmacovigilance processes, reviews and regulatory compliance, both in-house and in contract CROs. Working as a Clinical Trials Consultant since 2012, her main projects included safety and pharmacovigilance monitoring and implementation, analysis of safety data, safety data standards and data acquisition. Ling received several awards including CDISC Special Achievement Award 2013, NIDA’s Director’s Award and special recognitions at FDA and NIH.
Participants are eligible to receive CEUs upon attendance and successful completion of a web-based assessment within 30 days after the webinar. CEUs are not granted after the 30-day assesment deadline.
SCDM is authorized by IACET to offer 0.2 CEUs for this program.
For more information, please contact firstname.lastname@example.org