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FDAMap

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.

Gmp, Clinical Trials, FDA Regulations, FDA Compliance,

Pharmakologie und Arzneimittelentwicklung,    Translationale Medizin, Klinische Studien

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

Uventia Global

The Visual Inspection in Parenterals summit is a premier event that brings together experts from the pharmaceutical and biotechnology sectors to explore best practices, technologies and advancements in the visual inspection of parenteral products. Parenterals, which include injectable drugs and biologics, require stringent quality control measures to ensure their safety and efficacy. This conference will cover a wide range of topics such as the latest innovations in automated and manual visual inspection techniques, detection of particulate matter, container-closure integrity and regulatory requirements. Attendees will gain insights into cutting-edge technologies, industry standards and case studies aimed at enhancing the accuracy and reliability of visual inspections. The event will also provide valuable networking opportunities for professionals to collaborate and share expertise, fostering improvements in product quality and patient safety. This conference is essential for anyone involved in the manufacturing, testing and regulation of parenteral products.

Email: info@uventia.com

Regulatory and Compendial Requirements for Visual Inspection, Lifecycle Approach in Visual Inspection and Particle Management, Risk-Based Validation Case Studies, Inspector Training and Qualification, Deep Learning (DL) and Artificial Intelligence (AI) for Visual Inspection, Defect Classifications: Categorizing Defects and Nonconformities, Particulate Matter: Classification, Characterization & Control, Container Integrity Inspection and Leak Detection, New solutions for quality control of difficult to inspect parenterals

Pharmakologie und Arzneimittelentwicklung,    Biotechnologie

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.

Tel.: [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.

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