| November 13 | 2:00 - 4:00 p.m. Eastern This webinar is FREE. | | Topics Include: - Geriatric Patients in Clinical Studies
- Communicating Geriatric Information in Labeling
The goals of this webinar are to: - 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.
| 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
| | 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 2 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.
| | The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance, education and regular updates for regulated industry. This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, please contact us at CDERSBIA@fda.hhs.gov or 1-866-405-5367 or (301) 796-6707. | | | |
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