Bridging the Gap

Promoting Safe and Effective Prescription Drug Use in Geriatric Patients

Including Geriatric Patients in Clinical Studies and Communicating Geriatric Information in Labeling

November 13, 2020 | 2:00 p.m. - 4:00 p.m. Eastern

This webinar is FREE.

REGISTER

This webinar will discuss FDA’s geriatric clinical data initiatives to increase the quantity and quality of information about the use of prescription drugs in geriatric patients (particularly clinical studies in patients for the treatment of cancer), and help ensure that appropriate geriatric use information is consistently placed in prescription drug labeling so that the information is accessible to health care practitioners and guides the safe and effective use of prescription drugs in geriatric patients.

INTENDED AUDIENCE

This webinar is intended for industry, academia, and healthcare practitioners, including geriatricians, who:

Design and conduct clinical studies (with a focus on clinical studies in patients with cancer)
Develop, submit, review, or use prescription drug labeling

TOPICS COVERED

FDA’s initiatives to increase the enrollment of older adults (including patients 75 years of age and older) in clinical studies for the treatment of cancer
How to incorporate geriatric use information in the Geriatric Use subsection of labeling when a drug is approved for use in adult patients (including geriatric patients)
Geriatric use information in other sections and subsections in the labeling
Omitting, revising, and/or updating geriatric use information in labeling
Prescription drug labeling resources

CONTINUING EDUCATION

Real-time attendance is required for the certificate of attendance. Certificates are only available during the three weeks post-event. This course:

has been pre-approved by RAPS as eligible for up to two credits towards a participant’s RAC recertification upon full completion.
has been pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
has been pre-approved by SQA as eligible for 0.25 non-GCP or non-GLP units for every 1 hour of instructional time towards a participant’s RQAP re-registration.
has been approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.