Division of Clinical Research

Office of the Vice President and Innovation

Category results for: training

Searchable Database for Training Resources on FDA’s Updated CDER SBIA Learn Webpage

FDA’s CDER Small Business and Industry Assistance (SBIA) has revamped its CDER SBIA Learn webpage to include a comprehensive, searchable, easy-to-use database containing hundreds of training resources including recordings to webinars and conferences. This searchable database includes webinar and conference recordings from SBIA’s YouTube playlists from 2021, 2020, 2019 and 2018. SBIA also posts new conferences, webinars, and recordings on the SBIA LinkedIn page.

Jan-March 2021 CDER Meetings and Conferences

January Jan. 14 CDER Compliance Conference Jan. 26 Non-clinical Immunogenicity Assessment of Generic Peptide Products: Development, Validation, and Sampling Jan. 27 OTC Monograph Reform in the CARES Act: Safety Orders, Webinar Jan. 27 Public Meeting: Interim Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act Jan. 29 Regulatory Perspectives for Development of Drugs […]

Virtual CReSS Workshop

Corrective and Preventive Action (CAPA): What is it and when to use it Tuesday, August 4 from 3:00 p.m. – 4:30 p.m. Wednesday, August 5 from 9:00 a.m. – 10:30 a.m. For speaker information, learning objectives, and more information please see event flyer:

Replies to Inquiries to FDA on Good Clinical Practice

GCP inquiries submitted by the public to the FDA’s Good Clinical Practice Program’s gcp.questions@fda.hhs.gov e-mail account are now available online. FDA on GCP Link: https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/replies-inquiries-fda-good-clinical-practice Visit this FDA page to search through years of answers to GCP related questions on: Adverse Events Inquiries Computer Questions Device Study Inquiries FDA Forms 1571 and 1572 Financial Disclosure Inquiries Foreign […]

Fall 2019 Society of Clinical Research Associates (SOCRA) Certification Review and Exam

Friday, Aug. 16, 2019 – Informational Session for SOCRA Certification Exam 11:30 am – 12:30 pm, MMEC 11-102; sponsored in collaboration with Wright Center Translational Workforce Development Program and Massey Cancer Center.  Contact local SOCRA chapter co-chairs Patti Feldt,pafeldt@vcu.edu or Shirley Helm, shirley.helm@vcuhealth.org for additional information. SOCRA for Success 2019:  Registration open and is restricted to those registered for the […]

Managing Research with Open Science Framework

Managing Research with the Open Science Framework’ Tuesday, Jul. 25, 2017 from 10 a.m. to noon The VCU Data Science Lab holds a Reproducible Research Workshop in the Molecular Medicine Research Building, Room 1013. Participants will learn easy, practical steps researchers can take to increase the reproducibility of their work using the Open Science Framework. […]

Upcoming SoCRA Chapter Meeting (July 14)

Central Virginia SoCRA* Chapter Meeting Friday, July 14, 2017 from 11:30 a.m. to 12:30 p.m. The Wright Center for Clinical and Translational Research and VCU Massey Cancer Center present “Common Audit Findings and Ways to Avoid Them” in the McGlothlin Medical Education Building, Rooms 11-101 and 11-102. Participants will understand the purpose and goals of […]

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