Conférences  >  Médecine & Soins de Santé  >  Législation en médecine et pharmacologie  >  États-Unis

FDAMap

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.

Cro, Clinical Trial, Clinical Research Organizations, FDA Regulations, FDA Compliance

FDAMap

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.

FDA, Gmp, Clinical Trials, FDA Regulations, FDA Compliance,

Pharmacologie et développement des médicaments,    Médecine translationnelle, essais cliniques

FDAMap

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.

Cro, Clinical Research Organizations, Good Clinical Practice, Clinical Trial Management

Pharmacologie et développement des médicaments,    Médecine translationnelle, essais cliniques

CHI

Medtech MVP is an annual gathering of the leading innovators, investors and executives from around the nation discussing the timeliest issues and opportunities. This conference features candid discussions (panels or 1-on-1 conversations) that explore relevant topics for medtech innovators and business leaders as well as ample networking in a tight community. The many years of successful Medtech MVP programming have relied on insightful and beneficial perspectives and recommendations from our various keynotes and panels.

Tél.: [781.972.5400];     Email.: chi@healthtech.com

FDAMap

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.

FDA, 510(k) Submissions, FDA Regulations, FDA Compliance

Pharmacologie et développement des médicaments,    Médecine translationnelle, essais cliniques

Cambridge Healthtech Institute is proud to present the 17th Annual Next Generation Dx Summit which will take place at the Capital Hilton in Washington, D.C. on August 18-20, 2025. The Next Generation Dx Summit is the nexus for international thought leaders to discuss diagnostic advancement and technology innovation. This year’s event provides a valuable window on the state-of-the art, forecasting and future trends in point-of-care and decentralized testing, infectious disease, liquid biopsy, multi-cancer early detection, reimbursement, regulation, and companion diagnostics to improve standard of care in medicine. This must-attend Summit offers incomparable networking and complete coverage of the most timely and important topics for the industry.

Tél.: [781.972.5400];     Email.: chi@healthtech.com

Magnus Group

Prepare to immerse yourself in the 5th Edition of the International Vaccines Congress (IVC 2025), taking place from October 23-25, 2025, in the vibrant city of Orlando, Florida, USA! This highly anticipated International Vaccines Congress 2025 will offer a unique hybrid format, seamlessly blending onsite and online experiences to maximize global reach and participation. Dive deep into the latest advancements and transformative trends in vaccine science under the theme: From Discovery to Distribution: The Path of Vaccines.

Tél.: [17029882320];     Email.: vaccines@magnusconference.com