Overall Eval for Event Page
- CDER Track: Conference Evaluation & Certificate
- CDRH Track: Conference Evaluation & Certificate
- CBER Track: Conference Evaluation & Certificate
Session Evaluations
CDER (Drugs) Session Evaluations:
- Selective Safety Data Collection in Clinical Trials – Mary T. Thanh Hai
- Enhancing Clinical Trial Innovation – Kevin Bugin
- AI in Drug Development – Tala Fakhour
- ClinicalTrials.gov: Meeting Transparency and Reporting Requirements – Laurie Muldowney
- Diversity in Clinical Trials: Drug Trials Snapshot Perspective – Aden S. Asefa
- Combination Products – Updates and Best Practices – Kristina Lauritsen
- Introduction to SBIA – Renu Lal
- Key Information in Informed Consent (Clinical Trials) – Alyson Karesh and Suzanne R. Pattee
- FDA eCTD v4 Implementation Update and CDER NextGen Portal Update – Jonathan Resnick and Seyoum Senay
- Electronic Submission Gateway (ESG) Modernization: ESG NextGen – Jessica Bernhardt
- Artificial Intelligence (AI) | Machine Learning (ML): The New Frontier of Drug Development and Regulation – Qi Liu
- Reimagining Clinical Research: The Transformation of Trial Design & Conduct – Dave Burrow
- Advanced Manufacturing Technologies (AMT) Designation Program – Ranjani Prabhakara
- Jill P. Furman – Jill P. Furman
CDRH (Devices) Session Evaluations:
- Foundations of Medical Device Regulation in a World of Change – Kendra Holter
- Accelerating Medical Device Innovation with Regulatory Science Tools – Edward Margerrison
- Recognized Consensus Standards: The Ultimate Weapon to Streamline Conformity Assessment and Advance Innovation – Simon Choi
- Regulation of Medical Device Clinical Trials and Innovation in Clinical Evidence Generation – Christina Savisaar
- The 510(k) Program: Overview and Updates – Kathryn J De Laurentis
- Advancing Innovation in Healthcare with Combination Products – Hina Pinto
- Overview of the Final Rule and the Quality Management System Regulation – Joseph Tartal
- An Innovative Approach to Navigating the Quality Management System Regulation – Tonya A. Wilbon
- UDI for Patient Safety and Transformation – Indira Rao Konduri
- Global Market Innovation with Medical Device Export Certificates – Ruth Bediakoh
- Medical Device Reporting: Viewing Adverse Events as Opportunities for Transformation – Dianna Kenner-Staves
- Innovations in Medical Device Remanufacturing and Servicing – Katelyn Bittleman
- Step into the Closing Meeting: Navigating an FDA Closeout and Beyond – Sara Onyango
CBER (Biologics) Session Evaluations:
- Regulatory Approach for Gene Therapies: Incorporating Human Somatic Genome Editing – Brian Stultz
- Facilitating Development of Gene Therapies for Rare Diseases – Gopa Raychaudhuri
- Overview of CBER’s Office of Communication, Outreach and Development – Lorrie McNeill
- HCT/P Donor Screening/Testing and Requests for Exemption – Scott A. Brubaker
- Types of Regulatory Submissions – Cara Pardon
- Patient Engagement – Karen Jackler
- Use of Real-World Evidence in Accelerated Approval – Hector S. Izurieta
- Artificial Intelligence Challenges for Regulating Vaccine Development – Peter J. Weina
- CBER’s Advanced Manufacturing Programs for Sponsors – Sudhakar Agnihothram
- Postmarketing Surveillance for Product Safety in Pregnancy – Meghna Alimchandani
- Update on the ICH E2D(R1) Guideline: Post-Approval Safety Data – Craig Zinderman
- Blood Regulation and Safety – Orieji Illoh
- FDA Regulation of HIV Tests – Julia Tait Lathrop
- CBER Bioresearch Monitoring Program – Triet M. Tran
- CBER’s Perspective on Evaluation and Implementation of Rapid Microbial Methods – Seth Schulte
Virtual Attendance 1: *** Sunday thru 10:00 AM on Wednesday ***
Welcome, Keynote, and Plenary
Access to the broadcast will begin at ~8:00 AM (Eastern)
Both Logins track attendance for CE
Login issues? Not claiming CE?Use this link to skip login
There are no slides to download for these sessions
CDER (Drugs) Track
Logins will be activated at ~10:10 AM (Eastern)
CDER Login 1
CDER Login 2
Both Logins track attendance for CE
Login issues? Not claiming CE?Use this link to skip login
CDER Evaluation& Certificate
Evaluation link will beactivated at end of Day 1
CDRH (Devices) Track
Logins will be activated at ~10:10 AM (Eastern)
CDRH Login 1
CDRH Login 2
Both Logins track attendance for CE
Login issues? Not claiming CE?Use this link to skip login
CDRH Evaluation& Certificate
Evaluation link will beactivated at end of Day 1
CBER (Biologics) Track
Logins will be activated at ~10:10 AM (Eastern)
CBER Login 1
CBER Login 2
Both Logins track attendance for CE
Login issues? Not claiming CE?Use this link to skip login
CBER Evaluation& Certificate
Evaluation link will beactivated at end of Day 1
Virtual Attendance 2: *** 10:00 AM on Wednesday until 3:00 PM on Wednesday ***
CDER (Drugs) Track
Both Logins track attendance for CE
Login issues? Not claiming CE?Use this link to skip login
CDER Evaluation& Certificate
Evaluation link will beactivated at end of Day 1
CDRH (Devices) Track
Both Logins track attendance for CE
Login issues? Not claiming CE?Use this link to skip login
CDRH Evaluation& Certificate
Evaluation link will beactivated at end of Day 1
CBER (Biologics) Track
Both Logins track attendance for CE
Login issues? Not claiming CE?Use this link to skip login
CBER Evaluation& Certificate
Evaluation link will beactivated at end of Day 1
Virtual Attendance 3: *** 3:00 PM on Wednesday until 5:00 PM on Thursday ***
CDER (Drugs) Track
Logins will be activated at ~10:10 AM (Eastern)
Both Logins track attendance for CE
Login issues? Not claiming CE?Use this link to skip login
CDRH (Devices) Track
Logins will be activated at ~10:10 AM (Eastern)
Both Logins track attendance for CE
Login issues? Not claiming CE?Use this link to skip login
CBER (Biologics) Track
Logins will be activated at ~10:10 AM (Eastern)
Both Logins track attendance for CE
Login issues? Not claiming CE?Use this link to skip login
Virtual Attendance 0: *** Everything active for TESTING – Never published ***
Welcome, Keynote, and Plenary
Access to the broadcast will begin at ~8:00 AM (Eastern)
Both Logins track attendance for CE
Login issues? Not claiming CE?Use this link to skip login
There are no slides to download for these sessions
CDER (Drugs) Track
Logins will be activated at ~10:10 AM (Eastern)
Both Logins track attendance for CE
Login issues? Not claiming CE?Use this link to skip login
Evaluation link will beactivated at end of Day 1
CDRH (Devices) Track
Logins will be activated at ~10:10 AM (Eastern)
Both Logins track attendance for CE
Login issues? Not claiming CE?Use this link to skip login
Evaluation link will beactivated at end of Day 1
CBER (Biologics) Track
Logins will be activated at ~10:10 AM (Eastern)
Both Logins track attendance for CE
Login issues? Not claiming CE?Use this link to skip login
Evaluation link will beactivated at end of Day 1