Clinical Research Conference with ACRP and NWABR
Purchase contact hours here.
See event flyer here
Speakers:
Sholeh Ehdaivand, CEO and President, LMK Clinical Research Consulting
Raymond Nomizu, JD, Co-Founder & Co-CEO for Clinical Research IO
Wes Fishbourne, Product Manager for IBM
Rick Arlow, CEO and President, Complion
Ryan Jones, CEO Florence Health Care
Stephanie Williams, Regulatory Affairs for Cincinnati Children's Hospital
Dominic Chiarelli, Manager of Legal Affairs for Quorum Review IRB
Emily Gebbia, JD, Policy Staff Director with CDER (FDA)
Program Agenda:
- 8 – 8:30 am: Registration and Networking
- 8:30 – 8:45 am: Opening remarks from PNACRP and NWABR chapter presidents
- 8:45 – 9:45 am: Preparing for an FDA Audit
- 9:45 – 10 am: Break
- 10 – 11:15 am: (1) eSource for Sites, (2) Uses for CTMS at a Site, and (3) Getting on the Same Page: Improving Regulatory, Quality, & Efficiency with Standards
- 11:15 am – 12:15 pm: eRegulatory / eSource 2.0: Enabling Real-time Sponsor-Site Connectivity
- 12:15 – 1:15 pm: Lunch
- 1:15 – 2:15 pm: Increasing Clinical Trial Participation within Underrepresented Communities
- 2:15 – 3:15 pm: Regulatory Updates
- 3:15 – 3:30 pm: Break
- 3:30 – 4:45 pm: CDER BIMO Compliance and Enforcement: What You Need to Know
- 4:45 – 5 pm: Q&A with Emily Gebbia, JD (Policy Staff Director with CDER)
Program Description: Join the Pacific Northwest Chapter of ACRP and NWABR for the second annual Clinical Research Professionals Conference.
This year’s conference will highlight FDA audit readiness by featuring speakers on the topics of: Preparing for an FDA audit, improving quality and efficiency with e-source, CTMS, and e-regulatory binders, representative studies, newest updates in the regulations, and directly from the FDA on recent trends with audit findings.
The program will begin at 8 am, and will conclude at 5 pm after a Q&A with our speaker from CDER at FDA.
Upon completion of this Seminar, attendees should be able to:
- Establish a plan for what to do before, during, and after a regulatory inspection
- Describe the key trends underlying adoption of electronic source by research sites
- Identify a framework for managing the documents required to demonstrate compliance with ICH GCP
- Understand the importance of minority participation in clinical research and identify barriers to recruitment
Target Audience:
- CRCs
- CRAs
- Investigators
- Auditors
- Project Managers
- Regulatory Affairs/Compliance
- Data Managers (Site, Sponsor, CRO)
- Medical Monitor, Medical Officer, Project Physician
- Quality Assurance
- Clinical Research Administrators
Registration Cost:
- ACRP Members: $96
- Non-Members: $126
Contact hours: 6.5 ACRP contact hours have been approved for this presentation.
Membership is not required for online registration of contact hours.
To receive contact hours:
Purchase the contact hours at https://bit.ly/2RFGh8X, sign in at the event, and attend the program. Log on to the ACRP website then “My Learning Portal” to complete the evaluation no later than 30 days following the event and obtain the online certificate.
Contact Hour Cost:
- $0 Chapter Members
- $35 ACRP Members
- $50 Non-Members
Purchase contact hours here.
Refund Policy: None
Level: Med-level discussion, medical terminology helpful