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1
FDA’s GMP Expectations — FDA’s GMP Expectations for Phase I and First-in-Man Clinical Trials
05 Jun 2025 - 06 Jun 2025 • Washington DC, United States
Organizer:
FDAMap
Abstract:
Manufacturing an investigational product for the initial pilot clinical trials can be a complex and costly endeavor for developers. These first-in-man and pilot clinical trials, usually conducted with a small number of healthy participants, are primarily aimed at establishing safety. Therefore, they do not require a significant amount of investigational material. Recognizing this, the US FDA allows developers to test early-stage investigational products under relaxed GMP requirements.
Topics:
FDA, Gmp, Clinical Trials, FDA Regulations, FDA Compliance,
Event listing ID:
1662332
2
CRO Oversight — CRO Oversight for a Successful Clinical Trial
12 Jun 2025 - 13 Jun 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 Research Organizations, Good Clinical Practice, Clinical Trial Management
Event listing ID:
1662312
3
510(k) Submissions — 510(k) Submissions to the FDA: Hands-On Workshop
24 Jul 2025 - 25 Jul 2025 • Washington DC, United States
Organizer:
FDAMap
Abstract:
Each year FDA receives about 3000 applications for new devices via the 510k process, and about 60% of them are rejected either for poor quality application that cannot even be reviewed or for other technical reasons. Submissions to the FDA that are poorly organized, do not follow current practices, contain inconsistencies between documents, have missing or incomplete content, or poor structure will result in significant delays in the clearance process. With multiple review cycles, up to 90 days each, rejections by FDA could stretch the 510k clearance time-lines to 8 months or more. Most of the refuse-to-accept deficiencies are due to the inexperience of the 510k writers, who ignore the FDA rules. Writing and assembling a complete and well structured 510(k) submission will certainly improve the likelihood of FDA clearance on the first round.
Topics:
FDA, 510(k) Submissions, FDA Regulations, FDA Compliance
Event listing ID:
1662364


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Last updated: 14 May 2025