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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

Pharmakologie und Arzneimittelentwicklung,    Translationale Medizin, Klinische Studien

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.

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

Uventia

Join us for the 2nd Cleaning Validation Summit, a premier two-day event dedicated to best practices, regulatory expectations and emerging trends in pharmaceutical cleaning validation. This summit will bring together industry experts, regulatory professionals and practitioners to discuss critical topics, from regulatory guidelines (FDA, EMA, PIC/S) to risk-based cleaning validation strategies.

Tel.: [+420 732 640 977];     Email: info@uventia.com

Cleaning Validation, Containment, Bioprocessing, Aseptic Processing, Regulatory Affairs, Analytical Development, Quality Control, QC, Quality Assurance, QA, Risk Management, Drug, Sterility Assurance

Pharmakologie und Arzneimittelentwicklung,    Biochemie und Medizinische Chemie, Toxikologie

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