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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.

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, 510k, 510k Submission, FDA Compliance, FDA Regulations

Virtue Insight

Our conference provides the foundation for strong strategic planning and practical decision-making in your pharmacovigilance programs. This year’s conference will address the current thinking on predicting and assessing risks such as drug-induced liver injury, and the assessment of expectedness of serious adverse reactions during clinical development. Experts will present approaches and engage in dialogs around more extensive and impactful uses of real world data and generation of RWE for safety assessments. A full-day will be devoted to the development, implementation, and assessment of risk management strategies for drugs approved in multiple regions.

Tel.: [9361957193];     Email: kavitha@virtueinsight.co.in

Pharmacovigilance, regulatory affairs, Drug Safety, Drug Development, patient safety, RiskManagement, Pharmaceuticals, healthcare

Global Insight Conferences

Drive Progress By Harnessing The Patient Voice & Effectively Collaborating With Advocacy Groups ● Engage Key Stakeholders To Focus On Mutually-Beneficial Healthcare Outcomes ● Capitalise On Automation, New Tech & Digital Channels To Drive Engagement ● Break Down Industry Barriers & Overcome Disengagement To Reach More Patients

Marketing Manager;     Tel.: [+442034792299];     Email: info@patientengagementconference.com

Health Care Compliance Association (HCCA)