Meetings/Workshops on Clinical trials in the United States (USA)
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CHI's Clinical Trial Innovation Summit
24 Apr 2017 - 26 Apr 2017
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.
James Prudhomme; Phone: [781-972-5400]; Email: firstname.lastname@example.org
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
FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials
18 May 2017 - 19 May 2017
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.
Referral; Phone: ; Email: email@example.com
FDA GMP workshop, FDA GMP Expectations, Phase I, First-in-Man Clinical Trials, CMC Requirements, IND Study, Raw Material Management
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
27 May 2017 - 28 May 2017
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.
Peter Brown; Phone: [410-501-5777]; Email: firstname.lastname@example.org
Clinical Trials, GMP Phase 1, FDA GMP Regulations, FDA GMP Guidance
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Last updated: 29 March 2017