Conférences  >  Médecine & Soins de Santé  >  Médecine translationnelle, essais cliniques

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.

E CTD, E CTD Submissions, FDA Compliance, FDA Regulation

Législation en médecine et pharmacologie,    Pharmacologie et développement des médicaments

FDAMap

SOP deficiencies are one of the top 5 findings in FDA audits. The entire Quality Management System (QMS) of an organization could be severely compromised due to SOP defects. Formal written Standard Operating Procedures (SOPs) are required both by the FDA and EMA. Almost every deficiency identified in FDA’s 483s and Warning Letters can be traced back to deficiencies in SOPs at an organization. SOPs are often inadequate, miss important elements, do not contain important tools to increase compliance with the SOPs and, many times, are hard for the personnel who follow them to understand. They are frequently poorly written, communicated, monitored and enforced. This workshop will provide step by step instructions to create SOPs for FDA-regulated organizations.

FDA, SOPs, Quality Management System, Clinical Trials, Clinical Studies, Clinical Research, Clinical Development, FDA Regulation, FDA Complience

Législation en médecine et pharmacologie,    Pharmacologie et développement des médicaments

Virtue Insight

15th Annual Clinical Trials Summit 2024 will provide a platform to discuss on the futuristic advancements in Clinical Trials and clinical research. This multidisciplinary program involves broad participation of people from Clinical Trials community who are focused on learning more about clinical research, Clinical Trials planning & management. This event opens discussion of timely topics of mutual theoretical and practical interest for clinical trial investigators who are developing new drugs and biologics. This groundbreaking platform continues the conversation between business, academics, patient advocacy, and regulatory agencies to discuss new methods and solutions to statistical challenges relevant to the design and analysis of Clinical Trials collaboratively in the real world. It is high time that we look into innovative strategies, new technologies, effective and quality collaborations to address these issues, which can cater to the needs of the patient and the industry.

Email.: Kavitha@virtueinsight.co.in

clinical trials, clinical research, CROs, Clinical studies, drugs, regulatory, patients, clinical R&D, Medical Affairs, Regulatory Affairs, Quality control, pharma, pharmaceuticals

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.

This hands-on workshop is done by one of the industry’s top regulatory expert. The trainer has performed numerous reviews of 510(k) submissions over the last 15 years, and has analyzed the reasons that most often lead to delays in getting submissions ultimately cleared by FDA. This hands-on workshop will walk the attendees through the structure and key elements of the 510(k) submission and explains in clear language the most common pitfalls to avoid in the development of your 510(k) submission to the FDA.

FDA, 510 K Submission, 510 K Writers, FDA Compliance, FDA Regulations,

Législation en médecine et pharmacologie,    Pharmacologie et développement des médicaments

European Society for Medical Oncology (ESMO)

Brought to you by the European Society for Medical Oncology (ESMO), the congress will be the place to present very impactful new data in GI oncology. The scientific sessions will be complemented with high quality educational sessions and excellent networking opportunities.

In recent years we have seen remarkable progress in the treatment options available for patients with GI cancers and ESMO is committed to ensuring that there is a clear roadmap to help facilitate the implementation of new practice changing discoveries in the clinic for the benefit of all patients with GI cancers and whose wellbeing is our primary concern. The ESMO Gastrointestinal Cancers Congress will provide global visibility for original clinical and translational research.

Tél.: [+41 (0)91 973 19 62];     Email.: gicongress@esmo.org

Esophageal Cancer, Gastric Cancer, Hepatocellular Cancer, Pancreatic Cancer, Biliary Tract Cancer, Neuroendocrine Tumors, Colon Cancer, Rectal Cancer, GIST, Anal Cancer, Gastrointestinal Cancers

Cancérologie,    Gastro-entérologie

University of Granada

The IWBBIO 2024 (11th International Work-Conference on Bioinformatics and Biomedical Engineering) seeks to continue the good synergy obtained in the previous edition, providing a discussion forum for scientists, engineers, educators and students about the latest ideas and realizations in the foundations, theory, models and applications for interdisciplinary and multidisciplinary research encompassing disciplines of computer science, mathematics, statistics, biology, bioinformatics, and biomedicine. The aims of IWBBIO 2024 is to create a friendly environment that could lead to the establishment or strengthening of scientific collaborations and exchanges among attendees, and therefore, IWBBIO 2024 solicits high-quality original research papers (including significant work-in-progress) on any aspect of Bioinformatics, Biomedicine and Biomedical Engineering.

Email.: iwbbio@ugr.es

bioinformatics, bioimaging devices, biomedical, biomedical signal processing, biomedical computing, artificial intelligence, biotechnology,

Génomique et bio-informatique,    Génie biomédical

Johner Institut GmbH

Die Medical Device Days sind eine Speed-Consulting Konferenz für Medizinproduktehersteller, auf welcher sich die Teilnehmenden in kürzester Zeit zu sämtlichen regulatorischen Themen beraten lassen und weiterbilden können. Dabei stehen die Beantwortung der individuellen Fragen sowie der Austausch mit anderen Teilnehmenden und unserem Team im Vordergrund.

Email.: events@johner-institut.de

MDR, IVDR, Biokompatibilität, Risikomanagement, Künstliche Intelligenz, UDI, EUDAMED, Usability Engineering, QM, IT-Security, klinische Studien, klinische Bewertung, Regulatory Affairs, DiGA, Zulassung