Meetings/Workshops on Clinical trials in the United States (USA)

Conference-Service.com offers, as part of our business activities, a directory of upcoming scientific and technical meetings. The calendar is published for the convenience of conference participants and we strive to support conference organisers who need to publish their upcoming events. Although great care is being taken to ensure the correctness of all entries, we cannot accept any liability that may arise from the presence, absence or incorrectness of any particular information on this website. Always check with the meeting organiser before making arrangements to participate in an event!

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1.
 
CHI's Clinical Trial Innovation Summit
ID
875830
Dates
24 Apr 2017 - 26 Apr 2017
Location
Boston, United States
Abstract
Cambridge Healthtech Institute's 6th Annual Clinical Trial Innovation Summit brings together leaders from across pharma, biotech and academia to share case studies and best practices on effective clinical trial management and vendor oversight. The program focuses on key issues and opportunities in the clinical trial industry, including Patient Recruitment, Site Selection, Data Integration, Existing Data Sources, Mobile Tech, Project Management, Outsourcing, Vendor Management, Budgeting and Contracting, Quality (QbD) in Trial Conduct, Risk-Based Monitoring and Clinical Auditing.
Contact
James Prudhomme;     Phone: [781-972-5400];     Email: jprudhomme@healthtech.com
Topics
Patient Recruitment, Site Selection, Data Integration, Existing Data Sources, Mobile Tech, Project Management, Outsourcing, Vendor Management, Budgeting and Contracting, Quality (QbD) in Trial Conduct, Risk-Based Monitoring, Clinical Auditing
2.
 
FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials
ID
878164
Dates
18 May 2017 - 19 May 2017
Location
Tampa, United States
Abstract
Because a phase 1 clinical trial initially introduces an investigational new drug into human subjects, appropriate CGMP help ensure subject safety. It is important to implement quality control (QC) principles to the manufacture of phase 1 investigational drugs (i.e., interpreting and implementing CGMP consistent with good scientific methodology), which foster CGMP activities that are more appropriate for phase 1 clinical trials, improve the quality of phase 1 investigational drugs, and facilitate the initiation of investigational clinical trials in humans while continuing to protect trial subjects. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
FDA GMP workshop, FDA GMP Expectations, Phase I, First-in-Man Clinical Trials, CMC Requirements, IND Study, Raw Material Management
3.
 
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
ID
897943
Dates
27 May 2017 - 28 May 2017
Location
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. 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
Peter Brown;     Phone: [410-501-5777];     Email: pbrown@fdamap.com
Topics
Clinical Trials, GMP Phase 1, FDA GMP Regulations, FDA GMP Guidance

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Last updated: 29 March 2017