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1
FDA’s GMP Expectations for Phase I — FDA’s GMP Expectations for Phase I and First-in-Man Clinical Trials
24 Apr 2025 - 25 Apr 2025 • Washington DC, United States
Organizer:
FDAMap
Abstract:
By participating in this training, you will gain a deep understanding of the FDA's GMP expectations for Phase I and First-in-Man Clinical Trials. You will learn practical strategies that will enable you to navigate the regulatory landscape more effectively, ensuring FDA compliance while optimizing your resources.
Topics:
Gmp, Clinical Trials, FDA Regulations, FDA Compliance,
Event listing ID:
1659316
2
ISCT 2025
07 May 2025 - 10 May 2025 • New Orleans, United States
Organizer:
International Society for Cell & Gene Therapy
Event listing ID:
1651653
3
CRO Oversight — CRO Oversight for a Successful Clinical Trial
29 May 2025 - 30 May 2025 • Washington DC, United States
Organizer:
FDAMap
Abstract:
Many pharmaceutical, biotechnology, and medical device companies engage one or more Clinical Research Organizations (CROs) to conduct their clinical trials. However, managing a study through a CRO presents unique challenges compared to in-house operations, yet companies frequently lack formal training for this transition. Moreover, the recent update to the ICH Good Clinical Practice (GCP) guidelines underscores the Sponsor's responsibility to actively oversee their trials. Regulatory agencies are increasingly scrutinizing this aspect, identifying it as a potential weakness within Sponsor companies. This workshop addresses these critical issues by providing comprehensive training on effective CRO oversight. Participants will gain the knowledge and skills necessary to navigate the complexities of managing CRO-run projects, ensuring regulatory compliance, and optimizing trial outcomes. Through interactive sessions and practical insights, attendees will learn how to enhance their oversight practices and strengthen their organization's approach to clinical trial management.
Topics:
Cro, Clinical Trial, Clinical Research Organizations, FDA Regulations, FDA Compliance
Event listing ID:
1659685


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Last updated: 31 March 2025