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FDAMap

FDA now requires all DMFs be submitted only in the electronic CTD format which creates a huge burden on owners of most submissions. Converting to eCTD format requires special skills, software and resources, the cost of which could be prohibitive to small manufacturers. Our speaker, Dr. Mukesh Kumar, in this workshop will go over the details of the latest guidance on eCTD submission and explain the key takeaways.

ECTD Submissions, Regulatory Affairs, FDA Regulations, FDA Compliance

Legislation in der Medizin und Pharmakologie,    Translationale Medizin, Klinische Studien

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,

Legislation in der Medizin und Pharmakologie,    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 Research Organizations, Good Clinical Practice, Clinical Trial Management

Legislation in der Medizin und Pharmakologie,    Translationale Medizin, Klinische Studien

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

Legislation in der Medizin und Pharmakologie,    Translationale Medizin, Klinische Studien

CHI

Join a global community of thought leaders and innovators shaping the future of bioprocessing. Dive into cutting-edge research, share insights with industry experts, and tackle the challenges of bioprocess R&D, scale-up, quality, and analytics.

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

CHI

In its 23rd year Discovery on Target is the premier event highlighting “hot” drug targets and emerging modalities, technologies and strategies for pursuing those targets. The numerous conferences, symposia, courses and training seminars offer key insights for the successful discovery and development of novel therapeutics, from small molecules to biologics to chimeras and conjugates. The 4 day event covers innovations in target identification and lead generation, which includes cancer therapies, protein degradation, induced proximity, AI/machine learning, membrane proteins, translational models, synthetic biology and other relevant topics. New this year is an increased coverage of GLP-1, MASH and obesity, ADCs and bispecifics and on small molecules targeting DNA.

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

Onkologie,    Biotechnologie

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