Conférences  >  Médecine & Soins de Santé  >  Législation en médecine et pharmacologie

Health Care Compliance Association (HCCA)

Health Care Compliance Association (HCCA)

Health Care Compliance Association (HCCA)

Health Care Compliance Association (HCCA)

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 #510k Writers #FDA Compliance #FDA Regulations

Health Care Compliance Association (HCCA)

Cambridge healthtech Institute

Experience the Future of Biotherapeutic Drug Development Welcome to PEGS Boston The world’s largest gathering of protein engineering and biotherapeutics experts is back in Boston! PEGS Boston Summit is the leading biologics event with comprehensive programming covering all aspects of biologic drug development with in-depth presentations on protein and antibody engineering, immunotherapy, oncology, expression, analytics, immunogenicity, and more. Harness the power of in-person events, form genuine connections, create valuable relationships with peers, and become part of the PEGS community.

Cambridge healthtech Institute;     Tél.: [7819725400];     Email.: reg@healthtech.com

Academic Research, Analytical Research, Big Data, Biochemical, Bioengineering, Bioinformatic, Biological Science, Biomedicine, Bioprocessing, Biopsy, Biosciences, Biotech, Biotechnology, Cancer Research, Cell, Data, Data Management, Data Science, Discovery, Diseases, Disorders, Drug, Expo, Gene, Health, Health & Medicine, Healthcare, Manufacturers, Medical, Medical Science, Medicine, Research, research symposium, Science, Science and Technology, Scientific, Stem Cell, Tissue Repair,

Pharmacogénétique, Médecine personnalisée,    Biotechnologie

Health Care Compliance Association (HCCA)

FDAMap

​Clinical trials are highly regulated multi-dimensional projects that require constant interactions between the regulators and the sponsors, investigators, other personnel, and even patients involved in the conduct of a given trial. There are many diverse tasks involved in the conduct of a clinical trial starting from the development of a clinical trial protocol, finding and starting clinical trial sites, filing of an IND or IDE application, approvals from IRBs, numerous documents need to be collected to demonstrate compliance with regulations; managing supplies, collecting data, writing reports, and many other things. Clinical project managers need to understand, implement, and trouble-shoot practically all aspects of the clinical trial under them. Clinical project managers have to build teams and have clear perspective of what may be needed for assuring compliance with FDA requirements of a given clinical trial at all times. This one-of-a-kind program will train you in regulatory affairs, clinical operations, monitoring, patient recruitment and retention, planning, medical writing, safety monitoring and practically all major aspects of running a clinical trial.

#FDA #Clinical Trials #Clinical Studies #Clinical Research #Clinical Operations #Clinical Development #Clinical Trial Protocol #Clinical Project Management #Clinical Trial Sites #Clinical Project Managers #FDA Compliance #FDA Regulation

Pharmacologie et développement des médicaments,    Médecine translationnelle, essais cliniques

Health Care Compliance Association (HCCA)

Health Care Compliance Association (HCCA)

Health Care Compliance Association (HCCA)

Health Care Compliance Association (HCCA)

Health Care Compliance Association (HCCA)

Health Care Compliance Association (HCCA)

Health Care Compliance Association (HCCA)