Meetings/Workshops on Regulation in Medicine and Pharmacology in the United States (USA)

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Canada (1) - India (2) - Turkey (1) - United Kingdom (1) - United States (4) - ALL COUNTRIES (9)

1
FDA’s GMP Expectations for Phase I and First-in-Man Clinical Trials — FDA’s GMP Expectations for Phase I and First-in-Man Clinical Trials
09 May 2019 - 10 May 2019 • Boston, United States
Abstract:
Manufacturing an investigational product for the initial pilot clinical trials could pose a considerable logistical and financial challenge to developers. The first-in-man and pilot clinical trials are usually conducted in very small number of healthy participants with lower doses primarily to establish safety and hence do not need a significant amount of investigational material. The US FDA allows developers to test early stage investigational products under relaxed GMP requirements. The manufacturing requirements for early stage clinical trials are designed to assure adequate quality of the investigational product being tested without the excessive regulatory burden of full-scale GMP manufacturing. This workshop will present the current regulations, guidance documents and regulatory strategies available for manufacturing an early development stage product for Phase I and first-in-man clinical trials. Also discussed will be logistical issues with managing the supply of an early stage investigational product, and requirements for stability testing, storage and shipping, labeling, and documentations. Perspectives for different classes of products will be presented using case studies.
Contact:
Phone: [+410 501 5777];     Email: pkumar@fdamap.com
Event listing ID:
1196627
2
Clinical Project Management Training — One Day Online Training in Clinical Project Management
20 May 2019 • Washington DC, United States
Abstract:
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.
Contact:
Phone: [+410 501 5777];     Email: pkumar@fdamap.com
Event listing ID:
1196581
3
510(k) Submissions to the FDA: Hands-On Workshop
11 Jul 2019 - 12 Jul 2019 • Boston, United States
Abstract:
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.

Contact:
Phone: [+410 501 5777];     Email: pkumar@fdamap.com
Topics:
FDA 510(k) Approval, 510(k) Clearance, FDA 510(k) Submission, FDA Submissions, 510(k) Application, FDA 510(k) Strategy, FDA Clarence, FDA Approval
Event listing ID:
1200327
4
ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop
23 Sep 2019 - 25 Sep 2019 • Washington, D.C., United States
Organizer:
American Statistical Association
Event listing ID:
1145547

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Last updated: 24 February 2019