Wednesday, December 07, 2022
UNC CHER: The Color of Care Screening
All day
The Color of Care Screening
The Color of Care chronicles how people of color suffer from systemically substandard healthcare. COVID-19 exposed what they have long understood and lived: they do not receive the same level of care. Produced by Oprah Winfrey’s Harpo Productions and directed by Oscar-nominated and Emmy-winning director Yance Ford.
You can watch The Color of Care between December 5-December 12 in the Community Campus Partnership for Health Screening Room. Please note the access code is case sensitive, please enter it exactly as shown.
Access code for screening room: ccph
FDA: Virtual Clinical Investigator Training Course (CITC) 2022 - Day 1
Wed. 7 Dec, 2022 11:00 am - 3:35 pm
Overview
This course is designed to promote professionalism in the clinical trial industry for individuals involved with FDA submissions (Investigational New Drug (IND) Application, New Drug Application (NDA), Biologic License Application (BLA), and Investigational Device Exemption (IDE)), and to familiarize stakeholders with the regulatory and scientific issues involved in the development and approval of medical products. Participants will acquire a practical understanding of FDA’s approach to the evaluation of clinical trials, associated regulatory requirements, and other scientific issues related to investigational medical products.
Intended Audience
This is a clinical investigator training course targeted to all stakeholders in the clinical trial enterprise including industry, academia, and regulators (both local and foreign).The course is designed for clinical investigators, health care professionals (physicians, nurses, pharmacists, other healthcare workers), and individuals involved in biomedical research and the development of medical products.
Topics Covered
- Design and conduct of clinical trials
- Determining appropriate endpoints in clinical trials
- Efforts to advance diversity in trial populations
- Statistical evaluation of clinical trials
- Innovative trial designs
- Interpretation of the investigator brochure
- Clinical trial quality
Continuing Education
This webinar has been:
- pre-approved by RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
- 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.
- pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
- approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.
For more information about the event, please click here.
NIH: Human Subjects - Policies, Clinical Trials, and Inclusion
Wed. 7 Dec, 2022 12:00 pm - 4:00 pm
Overview
-What are the basic HHS regulations and NIH policies that apply to research involving human subjects, including clinical trials?
-How do you prepare a research proposal for review that addresses the regulatory requirements?
-What are some strategies for developing realistic and scientifically acceptable inclusion plans?
Join experts from the NIH Division of Human Subjects Research and HHS Office of Human Research Protections (OHRP) for answers to these questions and additional valuable information and resources. During this 2-day event, these NIH and HHS experts will share policies, resources, guidance, and case studies in this informative and engaging, live event.
For more information about the event, please click here.
In partnership with:
Contact Us
Brinkhous-Bullitt, 2nd floor
160 N. Medical Drive
Chapel Hill, NC 27599
919.966.6022
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